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| column | value |
|---|---|
| 類別 | 臨床試驗類,藥品生體可用率及生體相等性試驗準則 |
| 法規性質 | 行政解釋 |
| 法規名稱 | 公告生體相等性試驗之受託研究機構管理規範及查核表草案 |
| 條文內容 | <div class="WordSection1" style="layout-grid: 18pt none;"><p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 20pt;">生體相等性試驗之受託研究機構管理規範草案</span></b><b> </b></p><p><b><span style="font-family: 標楷體; font-size: 16pt;">壹、總則</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">為認定受託研究機構執行生體相等性試驗之操作及分析標準，健全受託研究機構之管理，依藥品生體可用率及生體相等性試驗準則第九條第四項之規定，訂定本規範。</span> </p><p><span style="font-family: times new roman, serif;">二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">本規範用詞，定義如下：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">不良事件</span><span style="font-family: times new roman, serif;">(adverse event)</span><span style="font-family: 標楷體;">：受試者參加試驗後所發生之任何不良情況</span><span style="font-family: 標楷體;">。</span><span style="font-family: 標楷體;">此項不良情況與試驗藥品間不以具有因果關係為必要。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗稽核</span><span style="font-family: times new roman, serif;">(audit of a trial)</span><span style="font-family: 標楷體;">：指由不直接涉及試驗之人員進行系統性檢查，以評估試驗的實施是否與法規</span><span style="font-family: 標楷體;">、</span><span style="font-family: 標楷體;">標準作業程序及試驗計畫書相符，資料報告是否與現場記錄一致，如：個案報告表中的資料報告和記錄是否與醫院病歷或原始記錄相符合。</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相等性</span><span style="font-family: 標楷體;">（</span><span style="font-family: times new roman, serif;">Bioequivalence</span><span style="font-family: 標楷體;">）</span><span style="font-family: 標楷體;">：指二個藥劑相等品或藥劑替代品，於適當研究設計下，以相同條件、相同莫耳劑量（molar dose）給與人體時，具有相同之生體可用率。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個案報告表</span><span style="font-family: times new roman, serif;">(case report form)</span><span style="font-family: 標楷體;">：指按試驗計畫書設計的報告表格，用以記錄受試者在試驗過程中的資料。資料收集過程必需確保資訊得以良好保存、維護並且可再取得，且方便驗證、稽核與查核。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">對照品</span><span style="font-family: times new roman, serif;">(comparator product)</span><span style="font-family: 標楷體;">：指臨床試驗中做為參考品之一種製劑或是其他產品（可以是安慰劑）。</span> </p><p><span style="font-family: times new roman, serif;">(六) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">委託</span><span style="font-family: times new roman, serif;">(contract)</span><span style="font-family: 標楷體;">：指一個由研究者、研究機構和臨床試驗委託者對財務問題與責任的授權與分配達成一致同意並共同簽章並註明日期之文件。包含以上資訊之試驗計畫並由責任人簽字，則可視為委託。</span> </p><p><span style="font-family: 標楷體;">(七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構</span><span style="font-family: times new roman, serif;">(contract research organization)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">和試驗委託者締約以承擔臨床試驗一部或全部工作之個人或機構。</span><span style="font-family: 標楷體;">此種委託必須有書面約定。 </span></p><p><span><span style="font-family: calibri;">(八) </span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">人體試驗委員會</span><span style="font-family: times new roman, serif;">(ethics committee or institutional review board)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">由具醫學背景之專業人員與非醫學背景之社會公正人士所共同組成之委員會，其責任在保護受試者之權利、安全與福祉</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: times new roman, serif;">(九) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">最終報告</span><span style="font-family: times new roman, serif;">(final report)</span><span style="font-family: 標楷體;">：指臨床試驗完成後對試驗所做的綜合描述。包括試驗方法和分析方法的描述，試驗用的材料，試驗結果的描述與分析，統計分析，還有一個嚴謹的合乎倫理與統計的臨床評估。</span> </p><p><span style="font-family: times new roman, serif;">(十) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥品優良臨床試驗準則</span><span style="font-family: times new roman, serif;">(good clinical practice)</span><span style="font-family: 標楷體;">：一套有關臨床試驗的設計、執行、監測、終止、稽核、分析、報告和記錄的標準，該標準乃為確保臨床試驗具科學性且符合倫理；並保證其臨床特性正確記錄，所得數據正確可信。</span> </p><p><span style="font-family: times new roman, serif;">(十一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥物非臨床試驗優良操作規範</span><span style="font-family: times new roman, serif;">(good laboratory practice)</span><span style="font-family: 標楷體;">：一套關於非臨床實驗室對於健康與環境安全研究之計畫、執行、監測、記錄、報告和檔案的組織架構和條件的品質系統。</span> </p><p><span style="font-family: times new roman, serif;">(十二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者同意書</span><span style="font-family: times new roman, serif;">(informed consent)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">受試者於受告知並了解將參與之臨床試驗之相關訊息，且參酌是否參與試驗之所有因素後，自願簽署願意參加試驗之文件</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: 標楷體;">(十三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">查核(inspection)：指藥品主管機關對一項臨床試驗進行的官方檢查，（檢閱包括品質管制、人員參與、授權與稽查等資料），查核作業可以在試驗單位、臨床試驗委託者或受託研究機構之處所進行，以證明</span><span style="font-family: 標楷體;">符合藥品優良臨床試驗準則</span><span style="font-family: 標楷體;">與</span><span style="font-family: 標楷體;">非臨床試驗優良操作規範</span><span style="font-family: 標楷體;">之規定</span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: times new roman, serif;">(十四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗用藥品的標籤</span><span style="font-family: times new roman, serif;">(investigational labelling)</span><span style="font-family: 標楷體;">：臨床試驗中試驗藥品的專用標籤。</span> </p><p><span style="font-family: times new roman, serif;">(十五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品</span><span style="font-family: times new roman, serif;">(investigational product or study product)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">臨床試驗中用來試驗之藥品，或當作參考之活性成分製劑或安慰劑。</span><span style="font-family: times new roman, serif;"> </span></p><p><span style="font-family: times new roman, serif;">(十六) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人</span><span style="font-family: times new roman, serif;">(investigator)</span><span style="font-family: 標楷體;">：試驗機構執行臨床試驗之負責人。指實施臨床試驗並對受試者權益、健康及福利負責的人。試驗主持人必須符合醫療法與藥事法相關規定要求之資格與能力。</span> </p><p><span style="font-family: times new roman, serif;">(十七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測員</span><span style="font-family: times new roman, serif;">(monitor)</span><span style="font-family: 標楷體;">：由臨床試驗委託者任命並對臨床試驗委託者或</span><span style="font-family: times new roman, serif;">CRO</span><span style="font-family: 標楷體;">負責之具備相關知識人員，其任務是監測及報告試驗的進行情況和核實資料。</span> </p><p><span style="font-family: times new roman, serif;">(十八) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥品</span><span style="font-family: times new roman, serif;">(pharmaceutical product)</span><span style="font-family: 標楷體;">：指使用於診斷</span><span style="font-family: 標楷體;">、</span><span style="font-family: 標楷體;">治療，減輕或預防人類疾病之原料藥或製劑。</span> </p><p><span style="font-family: times new roman, serif;">(十九) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">總試驗主持人</span><span style="font-family: times new roman, serif;">(principal investigator)</span><span style="font-family: 標楷體;">：指負責協調數個臨床試驗（如多中心臨床試驗）的試驗主持人。</span> </p><p><span style="font-family: times new roman, serif;">(二十) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書</span><span style="font-family: times new roman, serif;">(protocol)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">記載臨床試驗之目的、設計、方法、統計考量與編制等事項之文件，並得載明試驗之相關背景及理論。</span> </p><p><span style="font-family: times new roman, serif;">(二十一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗的品質保證</span><span style="font-family: times new roman, serif;">(quality assurance relating to clinical trials)</span><span style="font-family: 標楷體;">：為了確保臨床試驗之操作與資料之產出符合藥品優良臨床試驗準則與藥物非臨床試驗優良操作規範所建立的系統與品質管制程序。包括確保符合倫理和專業的臨床操作、標準作業程序、報告及人員的專業資格和技能等。</span> </p><p><span style="font-family: times new roman, serif;">(二十二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">原始資料</span><span style="font-family: times new roman, serif;">(raw data)</span><span style="font-family: 標楷體;">：指在臨床試驗當中用來重建或評估試驗的所有最初的觀察資料，臨床發現或臨床試驗中的其他活動的記錄或簽章的影本。這些資料包括：實驗室筆記，備忘錄，計算結果與文檔，還包括那些自動儀器的資料記錄與某些精確而簽章過的影本（比如：影印或縮影膠片形式的檔）。原始資料也包括相片底片，縮影膠片，磁介質（如電腦磁片）和光學介質（如</span><span style="font-family: times new roman, serif;">CD-ROMs</span><span style="font-family: 標楷體;">）。</span> </p><p><span style="font-family: times new roman, serif;">(二十三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">嚴重不良事件</span><span style="font-family: times new roman, serif;">(serious adverse event)</span><span style="font-family: 標楷體;">：指臨床試驗過程中發生包括死亡、危及生命</span><span style="font-family: 標楷體;">、</span><span style="font-family: 標楷體;">導致病人住院或延長病人住院時間、造成永久性殘疾、先天性畸形及其他需作處置以防永久性傷害的不良事件。</span><span style="font-family: times new roman, serif;"> </span></p><p><span style="font-family: times new roman, serif;">(二十四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗委託者</span><span style="font-family: times new roman, serif;">(sponsor)</span><span style="font-family: 標楷體;">：臨床試驗之發起及管理者。</span> </p><p><span style="font-family: times new roman, serif;">(二十五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作業程序</span><span style="font-family: times new roman, serif;">(standard operating procedures</span><span style="font-family: 標楷體;">；</span><span style="font-family: times new roman, serif;">SOP)</span><span style="font-family: 標楷體;">：為有效地實施和完成某一特定的臨床試驗中每項工作所擬定的標準和詳細的書面規程。</span> </p><p><span style="font-family: 標楷體;">(二十六) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">研究主持人</span><span style="font-family: times new roman, serif;">(study director)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">在生體相等性試驗，研究主持人負責主導試驗中生物檢體分析之工作。 </span></p><p><span style="font-family: times new roman, serif;">(二十七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者</span><span style="font-family: times new roman, serif;">(trial subject)</span><span style="font-family: 標楷體;">：指參加臨床試驗而接受試驗藥品或對照藥品之個人。這個人可以是：</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">願意參加試驗的健康受試者。</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個體情況與使用試驗藥品無關的人。</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個體情況與使用試驗藥品有關的人（通常是病人）。</span> </p><p><span style="font-family: times new roman, serif;">(二十八) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確效作業</span><span style="font-family: times new roman, serif;">(validation)</span><span style="font-family: 標楷體;">：確效作業系指有文件證明的作業程序，依據藥品優良臨床試驗準則與藥物非臨床試驗優良操作規範，證實任何步驟、處理、設備（包括使用的軟、硬體）、物料、進行之活動和系統確實一致且可致預期之結果。</span> </p><p><span style="font-family: times new roman, serif;">(二十九) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料驗證</span><span style="font-family: times new roman, serif;">(verification of data)</span><span style="font-family: 標楷體;">：指為確保最終報告中的資料與最初的觀察資料一致而採取的步驟。該步驟亦可是電腦程式，適用於原始資料，個案報告表中的資料（文書版或電子版），電腦列印輸出，資料分析和表格。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">貳、組織與管理</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應符合相關法規之規範。藥品製造廠之研發單位，亦同。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應有組織架構圖，載明主要負責人姓名與職務，並經負責人簽名授權及加註日期。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">所有工作人員應有工作業務之說明文件，包括主要負責人之責任範圍。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">人員之簽名樣式應作成列表。</span> </p><p><span style="font-family: times new roman, serif;">四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦及硬體設備，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦數量應足供人員進行資料登錄、資料管理、計算與編寫報告。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦應有充足之空間與記憶體。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">輸入及儲存於電腦之試驗相關資料應有明確方法進行控管。對於有權控管資料庫之人員應作成列表保存。</span> </p><p><span style="font-family: times new roman, serif;">五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦軟體，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦軟體之選用應符合實際需要。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">選用軟體程式、病毒掃描頻次、資料儲存，及備份檔之製作、存檔、保存等事件，應有文件明確說明。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">選用軟體應能達到品質及資訊管理之需求，並應保證其可信度與準確性。資料處理軟體應至少包含文書處理、資料登錄、資料庫、圖表製作、藥動學與統計學軟體。使用者自行設計之軟體，亦同。</span> </p><p><span style="font-family: times new roman, serif;">六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入，指將原始資料、個案報告表、分析性資料傳輸至電腦系統，作為藥動學運算或統計學分析及報告之用。</span> </p><p><span style="font-family: times new roman, serif;">七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入程序宜具防止錯誤發生之設計，並有標準作業流程詳細說明。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入宜採複式輸入法。資料校對、複式輸入、電子邏輯控制等資料確效之方法學，應提出詳細說明。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">更改資料庫之資料應由專人或其授權之人為之，並詳細記錄。</span> </p><p><span style="font-family: times new roman, serif;">八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應規劃適當之空間，並能防火，以供儲存臨床試驗資料檔案與試驗藥品等。</span> </p><p><span style="font-family: times new roman, serif;">九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲存檔案，應符合以下要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲存檔案應有標準作業程序。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檔案室出入應進行管制，非經授權之人不得出入。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作業流程對試驗原始資料與研究紀錄之儲存期限應詳為規定。</span> </p><p><span style="font-family: times new roman, serif;">十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢品保存期間應依相關法規之規定，並於標準作業流程中詳細說明。</span> </p><p><span style="font-family: times new roman, serif;">十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗應在保證受試者安全之條件下進行，其單位場所之選擇應考量產品研發階段及潛在危險性。</span> </p><p><span style="font-family: times new roman, serif;">十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應規劃充足空間，供相關試驗人員住宿、活動或進行試驗之用。</span> </p><p><span style="font-family: times new roman, serif;">十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗場所應有實驗室及其他足夠設施，並應妥為規劃設置，以利試驗活動順利進行。試驗場所之出入應進行管制。</span> </p><p><span style="font-family: times new roman, serif;">十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室之設置，應以適於人員之實驗操作為原則，並應有充足空間，以防止藥品混淆、汙染或交叉汙染，及供儲藏檢品、標準品、儀器、設備、溶劑、試劑和紀錄。儲藏室等重要區域之溫度控制應設預警系統，定期進行測試，以確保其正常運行。每日之溫度記錄應保存，如有檢測預警系統，亦應記錄之。</span> </p><p><span style="font-family: times new roman, serif;">十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗場所應有電話、傳真及發送電子郵件之設備，以確保與外界之正常聯繫。此外，受託研究機構亦應配置印表機或影印機等必要之辦公設備，以完成其工作。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">參、臨床期之管理</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相等性試驗為人體試驗，應符合醫療法及其授權相關法令、藥事法及其授權相關法令之規定。</span> </p><p><span style="font-family: times new roman, serif;">十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗應於符合法規規定之醫療機構內進行，並應確保受試者之安全。</span> </p><p><span style="font-family: times new roman, serif;">十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">進行試驗之醫療機構，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">應有足夠空間，以容納受試者。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">夜間工作之辦公設施及床位，得依試驗類型及試驗藥品之需要，在適當條件下提供配置，並應於試驗計畫書中載明。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">更換、存放、清洗衣物或供盥洗之處所，應設於研究人員易於所及之處，其數量並應符合人數之需要。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗場所應配置下列設施，必要時並應有適當之區隔：</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者登記和檢查之處所。</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">供受試者休閒之處所。</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">其他附屬於受試者之場所。</span> </p><p><span><span style="font-family: calibri;">4</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">供儲藏、重新包裝、調劑、記錄等藥事作業用之管制進出場所。</span> </p><p><span><span style="font-family: calibri;">5</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">供藥品之定量、給藥，及檢體收集之處所。</span> </p><p><span><span style="font-family: calibri;">6</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">血漿分離、冷藏室等檢品處理或儲藏之處所。</span> </p><p><span><span style="font-family: calibri;">7</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲存試驗器材、藥品、文件檔案與個案報告表之監控場所。</span> </p><p><span><span style="font-family: calibri;">8</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">準備標準餐食及用餐之處所。</span> </p><p><span><span style="font-family: calibri;">9</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">緊急情況下可用的資源、搶救設備，及緊急事件中必備之急救藥品。</span> </p><p><span><span style="font-family: calibri;">10</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">緊急救護或其他醫療救護時，足供妥善照顧受試者之設施。</span> </p><p><span><span style="font-family: calibri;">11</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">存檔設施。</span> </p><p><span style="font-family: times new roman, serif;">十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體分析應於合適且符合標準之分析實驗室進行。</span> </p><p><span style="font-family: times new roman, serif;">二十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">血液檢查、尿液檢查或其他檢驗，應於試驗計畫書所定之試驗期間進行。</span> </p><p><span style="font-family: times new roman, serif;">二十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應有實驗室分析方法、必要時須提供載明日期之實驗室分析標準範圍，及實驗室認證證書等具體資料。</span> </p><p><span style="font-family: times new roman, serif;">二十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室的資料檔中，應有負責分析人員簽署之最新個人簡歷。</span> </p><p><span style="font-family: times new roman, serif;">二十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室應替每一位受試者建立單獨之報告檔案，作為個案報告表之一部分，並應有所有試驗測試的原始資料存檔。</span> </p><p><span style="font-family: times new roman, serif;">二十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應有充足的工作人員從事臨床試驗，相關人員應具備特定資格並經專門培訓。員工人數應視受託研究機構從事臨床試驗之多寡及難度以決定。</span> </p><p><span style="font-family: times new roman, serif;">二十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">為保證受試者之權利、安全及健康，包括夜晚在內之試驗期間內，應維持足夠之合格且經專門培訓之員工人數，並應在突發事件中妥善照顧受試者。</span> </p><p><span style="font-family: times new roman, serif;">二十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相等性試驗之運作及分析，應由下列關鍵人員負責執行：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">醫學或科技指導員。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">主要試驗主持人或試驗主持人，與協同主持人。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">研究主持人。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">品質保證經理。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">技術經理。</span> </p><p><span style="font-family: times new roman, serif;">(六) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">品質管制經理。</span> </p><p><span style="font-family: times new roman, serif;">二十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">除負責品質保證之人員應為獨任外，同一人員得兼任其他職務。品質保證人員並應將稽核結果向機構之最高管理階層彙報。</span> </p><p><span style="font-family: times new roman, serif;">二十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構得雇傭兼職人員從事一定工作，惟其簡歷與培訓記錄皆應比照全職人員記錄在案。</span> </p><p><span style="font-family: times new roman, serif;">二十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">負責計畫及實施研究的管理人員應有適當之資格，並具備相關領域之專業知識與經驗。</span> </p><p><span style="font-family: times new roman, serif;">三十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥物非臨床試驗優良操作規範與藥品優良臨床試驗準則之培訓及考核，應作成紀錄並保存。</span> </p><p><span style="font-family: times new roman, serif;">三十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">品質保證，應符合下列之要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應有相應之品質保證系統。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">品質保證人員及其負責人，應獨立於試驗執行或監測員之外。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">品質保證單位之主要職責如下：</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">稽核試驗過程中所進行之任何活動。</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確保品質保證系統與受託研究機構的標準作業程序之順利運作、複核及更新。</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確保所有資料之可信度與可追溯性。</span> </p><p><span><span style="font-family: calibri;">4</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">依照標準作業程序，於固定且特定之時間內，計畫執行內部稽核工作，必要時並追蹤矯正措施之進度。</span> </p><p><span><span style="font-family: calibri;">5</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確保分析實驗室及其他委託單位依藥物非臨床試驗優良操作規範進行，包括稽核實驗室設施，必要時並追蹤矯正措施之進度。</span> </p><p><span><span style="font-family: calibri;">6</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">審核臨床報告，並確保臨床報告能準確且完整反映研究結果資料。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗委託人如欲對試驗進行監測，或對臨床試驗、分析與實驗場所進行稽核，受託研究機構不得拒絕。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">分析實驗室應設立獨立之品質保證單位。品質保證單位應與負責分析工作之人員分別獨立，以確保試驗採用最新之分析方法並通過確效作業。</span> </p><p><span style="font-family: times new roman, serif;">三十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應於臨床試驗執行前依法經獨立之人體試驗委員會核准。人體試驗委員會會期內之討論、建議、結論，應詳實記錄；人體試驗委員會應有充足之時間，對臨床試驗計畫書、受試者同意書及相關文件進行評審。</span> </p><p><span style="font-family: times new roman, serif;">三十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者同意，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者同意，應使用受試者或其法定代理人可理解之語言文字，以口頭及書面之形式為之。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者同意應依藥品優良臨床試驗準則之規定，於臨床試驗各項步驟進行前完成，並記錄存檔。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者得不附任何理由，隨時退出試驗。有附理由者，應記錄之。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者應受明確告知有關保險及因參與試驗而致傷殘所受之補償和治療等資訊。</span> </p><p><span style="font-family: times new roman, serif;">三十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗之監測，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測員應具備一定資格，負責確保試驗過程依據計畫書、藥品非臨床試驗優良操作規範、藥品優良臨床試驗準則、試驗倫理及相關法規進行，包括指引個案報告表及試驗資料依正確程序進行。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">委託人得將監督管理之工作委託予受託研究機構，但以特殊情形，且該受託研究機構已依法規要求安排臨床試驗監測工作者為限。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測調查之頻次由委託人與受託研究機構協商定之，惟臨床試驗執行前、執行中與完成後，均應至少執行一次監測。監測員並應於各次監測調查後作成書面報告。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應製作關於監測調查、原始資料審核範圍、藥品管理責任和履行試驗計畫相關之書面標準作業流程。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測員於期前調查、期中常規調查、期末調查，應各有一份書面標準作業程序。</span> </p><p><span style="font-family: times new roman, serif;">三十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人，應符合下列之要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人應對臨床試驗之執行負完全責任，包括試驗設計、試驗用藥之管理、與主管機關或人體試驗委員會之聯繫、計畫書及試驗報告之簽署。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人，其資格應符合人體試驗管理辦法之規定</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">具醫師資格之試驗主持人應負責受試者在臨床試驗期間之安全、健康與福利，並具實記錄試驗相關之臨床數據。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人由受託研究機構選任之，如試驗主持人非受託研究機構長期聘雇者，並應與受託研究機構簽訂書面契約，並經適當培訓。</span> </p><p><span style="font-family: times new roman, serif;">三十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應詳實記錄、儲存臨床試驗各階段之試驗藥品與對照藥品之接收、儲存、處理、責任管理等一切資訊，並應做好剩餘試驗藥品之出貨、遞送、接收、儲存、調劑、給藥、複核，以及剩餘藥品退回與銷毀之紀錄。</span> </p><p><span style="font-family: times new roman, serif;">三十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品之資訊內容，應包括藥品劑型、劑量、批號、有效期限，以及其他可資鑑別藥品特殊性質之代碼。</span> </p><p><span style="font-family: times new roman, serif;">三十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品應預留原包裝藥品，以備未來必須確認之用。</span> </p><p><span style="font-family: times new roman, serif;">三十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應具適當之空間，並與社區藥局或醫院藥局共同承當試驗藥品與對照藥品之儲存、遞送、退回和記錄。</span> </p><p><span style="font-family: times new roman, serif;">四十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品應在適當條件下保存，其保存條件應達委託人提供之藥典或藥品資訊所載之標準。</span> </p><p><span style="font-family: times new roman, serif;">四十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品應存放於特定區域並上鎖，非經授權之人不得進入。</span> </p><p><span style="font-family: times new roman, serif;">四十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥品之隨機取樣與調劑，包括貼標作業，應依藥品優良製造規範、藥品優良調劑作業準則及標準作業程序操作，並應保留相關之紀錄。</span> </p><p><span style="font-family: times new roman, serif;">四十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">執行下列項目應記錄存檔，並得參酌藥品優良製造規範之規定：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確保隨機取樣可操作性所採行之措施。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">免除可能錯誤所採行之措施，包括清理線路、分開操作試驗藥品及對照品、由他人對操作進行監督等。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">執行完畢之調整。</span> </p><p><span style="font-family: times new roman, serif;">四十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥品調劑，應由監測員或其他人員進行複核。</span> </p><p><span style="font-family: times new roman, serif;">四十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人應照試驗計畫書之要求執行臨床試驗及隨機取樣，必要時得使用盲性設計。</span> </p><p><span style="font-family: times new roman, serif;">四十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人應確認藥品劑量之準確，並確保試驗藥品之紀錄檔案、投與受試者之藥品名稱、成分、劑量等記錄之真確。</span> </p><p><span style="font-family: times new roman, serif;">四十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個案報告表應記錄臨床試驗過程中每一位受試者之研究資料。</span> </p><p><span style="font-family: times new roman, serif;">四十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">必要時，委託人得要求受託研究機構提出個案報告表設計步驟，或採用標準格式。表格之設計以符合個別研究之需要為考量。</span> </p><p><span style="font-family: times new roman, serif;">四十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細載明自每一位受試者身上欲蒐集之資料，並應附空白個案報告表樣式乙份。</span> </p><p><span style="font-family: times new roman, serif;">五十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個案報告表中應獲取、保持與留存受試者資訊，並應反映研究中所獲之真實資料，且易於對資料進行審核、稽核與查核。</span> </p><p><span style="font-family: 標楷體;">五十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主持人應確認個案報告表之正確性，且應有標準程序及紀錄。個案報告表上如有錯誤、其增刪或修改應載明緣由，刪改之日期及刪改人簽名等資料。 </span></p><p><span style="font-family: times new roman, serif;">五十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">每一位受試者應保存一檔案，以記錄其參與各階段臨床試驗之過程，並記錄對於後續研究有用之資訊。</span> </p><p><span style="font-family: times new roman, serif;">五十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相等性試驗之受託研究機構，應預備足夠之健康受試者，並已事先經醫師檢查及篩選。</span> </p><p><span style="font-family: times new roman, serif;">五十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">篩選符合試驗所需之受試者前，應先取得其受試者同意書。於研究中所進行之任何篩選，亦同。</span> </p><p><span style="font-family: times new roman, serif;">五十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書中應載明受試者招募之程序及篩選合格之標準。</span> </p><p><span style="font-family: times new roman, serif;">五十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗期間應嚴格控制受試者空腹與進食，以避免食物攝取量明顯影響藥品之吸收。餐點、飲料應依臨床試驗計畫書提供予受試者。</span> </p><p><span style="font-family: times new roman, serif;">五十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">進食之時間、期間及食物與液體之攝取量應記錄並保存。</span> </p><p><span style="font-family: times new roman, serif;">五十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">合理的試驗計畫應充分評估受試者可能發生之任何危險。試驗過程應有計劃、有組織的執行與管理，並應得所有受試者及相關人員認可。</span> </p><p><span style="font-family: times new roman, serif;">五十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗場所應備有急救設備與藥品，並有充足設施以應受試者搶救或其他醫療護理之需。</span> </p><p><span style="font-family: times new roman, serif;">六十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">發生不良反應時，試驗主持人應對其醫療判斷負責，並立即通報相關醫療機構、試驗委託人，必要時應通知人體試驗委員會，不得遲誤。如發生嚴重不良事件，應依有關法令之規定，於限期內通報。</span> </p><p><span style="font-family: times new roman, serif;">六十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受託研究機構應提供試驗主持人有關登記、通報不良反應之適當表格，並作為個案報告表之一部分。必要時，亦得採用其他委託人所提供之表格。</span> </p><p><span style="font-family: times new roman, serif;">六十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體規格、取樣方法、容積及數量應於試驗計畫書中規定，並提供資訊予受試者。血漿檢體中抗凝血劑的使用，亦同。</span> </p><p><span style="font-family: times new roman, serif;">六十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體之採集、準備、運輸及貯存，應完整記錄其過程。</span> </p><p><span style="font-family: times new roman, serif;">六十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體之實際採集次數、時間與原訂計畫有出入時，應記錄之。</span> </p><p><span style="font-family: times new roman, serif;">六十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">採集生物檢體之標籤應清晰，以確保能真確鑑別及追溯。</span> </p><p><span style="font-family: times new roman, serif;">六十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體貯存條件應根據研究藥品之特性為之。所有貯存條件應於試驗計畫書中說明。貯存期間與運輸途中之貯存條件亦應受控制、監測並記錄，且宜保證系統發生錯誤時，仍能確保生物檢體之完整性。</span> </p><p><span style="font-family: times new roman, serif;">六十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體之貯存及回收紀錄應保存。</span> </p><p><span style="font-family: times new roman, serif;">六十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體宜雙套保存或備份，並分開貯存、運輸。</span> </p><p><span style="font-family: times new roman, serif;">六十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體及其相關耗材之處理、銷毀或回收應符合相關法令之規定。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">肆、生物檢體分析期之管理</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">七十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥品濃度分析得由執行臨床試驗之同一受託研究機構進行，亦得委託其他符合資格受託研究機構為之。</span> </p><p><span style="font-family: times new roman, serif;">七十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗之生物檢體分析，應符合藥物非臨床試驗優良操作規範，並應在已建立品質保證之實驗室中進行。</span> </p><p><span style="font-family: times new roman, serif;">七十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體分析之場地與設備，應符合下列要求：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室分析應有足夠空間與基本設備，各別流程應有相互隔離之操作區域，並留意檢品在製備及分析流程中之交互混雜或汙染。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">水、氣、油、電等資源之供應應充足、穩定及連續。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">分析設備及儀器應精確校正、維護以符合標準。分析之方法應記錄並執行確效。</span> </p><p><span style="font-family: times new roman, serif;">(四) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">設備之操作、使用、校正及預防性維護，均應有標準作業程序，並應保留紀錄。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗中使用之設備均應進行鑑定、校正並確認其符合標準，以確保其可追溯性。</span> </p><p><span style="font-family: times new roman, serif;">七十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細說明分析方法之確效作業程序。不同分析方法亦應有其各別之標準作業要求。</span> </p><p><span style="font-family: times new roman, serif;">七十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告書中應提出資料，說明檢體保存於特定環境下之安定性。</span> </p><p><span style="font-family: times new roman, serif;">七十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">化學藥品、試劑、溶劑與溶液應標示其成分、有效期限及特殊貯存條件，並宜標示其鑑別、純度或雜質濃度、來源、製備日期及安定性資料。</span> </p><p><span style="font-family: times new roman, serif;">七十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">各次分析作業均應包含校正及品管用檢品之分析資料，其分析標準並應於標準作業程序中說明。</span> </p><p><span style="font-family: times new roman, serif;">七十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用層析法分析，應於標準作業流程中敘明層析法之驗證及層析圖譜標準積分。各批次之受試者檢品、校正檢品及品管用檢品應一併處理。層析圖譜之再處理應交由經適當訓練之人員執行，並應保存其紙本記錄或電子稽核檔案。</span> </p><p><span style="font-family: times new roman, serif;">七十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作業程序中應詳細載明檢體再分析結果報告之標準。試驗報告並應列出再分析檢體之清單、再分析之原因、再分析結果數據及試驗報告書中所呈現之數據。</span> </p><p><span style="font-family: times new roman, serif;">七十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗期間內所有品管檢體之分析結果，均應於試驗報告中敘明並納入統計分析，非因特別分析問題不得任意捨棄。捨棄之原因應詳為敘明。試驗前之分析方法確效，亦同。</span> </p><p><span style="font-family: times new roman, serif;">八十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">所有原始分析資料應作成紀錄，並應確保日後能追溯檢體數量、所用設備、分析日期與時間，及操作人員姓名。層析法分析之原始圖譜，應以適當比例呈現，其峰形與峰值應清晰可見。</span> </p><p><span style="font-family: times new roman, serif;">八十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">每一數據點應足以追溯對應特定之檢體，其所提供之資料應包括檢體數量、採樣時間及分析時間，並得提供離心過濾時間或冷凍時間等資料，使研究主持人得以判斷可能之異常結果與檢體錯誤是否相關。</span> </p><p><span style="font-family: times new roman, serif;">八十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室應具備編碼技術，必要時應有方法以進行盲性分析。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">伍、藥動學與統計</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">八十三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗結果之計算應由符合資格之人員進行。</span> </p><p><span style="font-family: times new roman, serif;">八十四<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細載明計算方式。資料之分析亦應滿足計畫書之需求。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">陸、試驗報告</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">八十五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告應準確呈現所有試驗過程及結果。</span> </p><p><span style="font-family: times new roman, serif;">八十六<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告之書寫應完整簡明，試驗過程中任何與試驗計畫相異之處，均應於試驗報告書中說明。</span> </p><p><span style="font-family: times new roman, serif;">八十七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告之結果資料應與原始紀錄無差異。</span> </p><p><span style="font-family: times new roman, serif;">八十八<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告之撰寫應依相關法規之規定，按標準格式撰寫。</span> </p><p><span style="font-family: times new roman, serif;">八十九<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告應有生物檢體分析報告，包括生物檢體分析之方法說明，及分析方法確效作業報告。</span> </p><p><span style="font-family: times new roman, serif;">九十<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告應詳細說明試驗主持人與委託人對試驗報告之許可程序，且宜有詳細且明確的標準程序。</span> </p><p><span style="font-family: times new roman, serif;">九十一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗報告應有相關負責人員之簽名，並加註日期。</span> </p><p><span style="font-family: times new roman, serif;">九十二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">最終試驗報告公開前，應有完整監測報告及稽核報告。</span> </p><span style="font-family: times new roman, serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">生體相等性試驗臨床試驗場所查核表</span> </p><p style="text-align: center; layout-grid-mode: char;"> </p><table width="100%" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="background-color: transparent;border: #f0f0f0;"> <div> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">附件一</span> </p> </div> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: calibri; font-size: 14pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 14pt;">醫療機構名稱</span><span style="font-family: calibri; font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">地址</span><span style="font-family: calibri; font-size: 14pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="695" style="width: 521.1pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 28.5pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; padding-right: 1.4pt; height: 28.5pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.55pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">項</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">目</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.35pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 449.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試</span><span> </span><span style="font-family: 標楷體;">驗</span><span> </span><span style="font-family: 標楷體;">場</span><span> </span><span style="font-family: 標楷體;">所</span><span> </span><span style="font-family: 標楷體;">之</span><span> </span><span style="font-family: 標楷體;">設</span><span> </span><span style="font-family: 標楷體;">施</span><span> </span><span style="font-family: 標楷體;">（一）</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.55pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;">1. </span><span style="font-family: 標楷體;">應提供適當之急救設施，急救設備至少應包含下列項目：</span> </p> <p><span style="font-family: calibri; text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">救</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">器</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">具</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">名</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">稱</span><span style="font-family: calibri; text-decoration: underline;"> </span></p> <p><span style="font-family: 標楷體;">急救車</span> </p> <p><span style="font-family: 標楷體;">心臟電擊器</span> </p> <p><span style="font-family: calibri;">EKG</span><span style="font-family: 標楷體;">監視器</span> </p> <p><span style="font-family: 標楷體;">喉頭鏡</span> </p> <p><span style="font-family: 標楷體;">抽痰機</span> </p> <p><span style="font-family: 標楷體;">氧氣筒</span> </p> <p><span style="font-family: 標楷體;">氧氣罩或攜帶式氧氣製造機</span> </p> <p><span style="font-family: 標楷體;">血壓計</span> </p> <p><span style="font-family: 標楷體;">點滴架</span> </p> <p><span style="font-family: 標楷體;">點滴輸液套</span> </p> <p><span style="font-family: 標楷體;">靜脈留置針</span> </p> <p><span style="font-family: 標楷體;">氣管內管（含</span><span style="font-family: calibri;">No.6.0/ 7.0 /7.5 /8.0</span><span style="font-family: 標楷體;">）</span> </p> <p><span style="font-family: 標楷體;">輪椅</span> </p> <p><span style="font-family: 標楷體;">氧氣推車</span> </p> <p><span style="font-family: 標楷體;">離心機</span> </p> <p><span style="font-family: 標楷體;">針頭銷毀機</span> </p> <p><span style="font-family: 標楷體;">電冰箱</span><span style="text-decoration: underline;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.35pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div><p style="layout-grid-mode: char; 36: ;"><span style="font-family: 標楷體;">★ </span><span style="font-family: 標楷體;">各項設施之數量以符合需要為要求</span> </p></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><div class="WordSection2" style="layout-grid: 18pt none;"><div style="text-align: center;"><table width="690" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.3pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 26.9pt; padding-right: 1.4pt; height: 26.3pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">項</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">目</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 323.2pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 26.9pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試</span><span> </span><span style="font-family: 標楷體;">驗</span><span> </span><span style="font-family: 標楷體;">場</span><span> </span><span style="font-family: 標楷體;">所</span><span> </span><span style="font-family: 標楷體;">之</span><span> </span><span style="font-family: 標楷體;">設</span><span> </span><span style="font-family: 標楷體;">施</span><span> </span><span style="font-family: 標楷體;">（二）</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;">2. </span><span style="font-family: 標楷體;">應提供適當之急救設施，急救藥品至少應包含下列項目：</span> </p> <p><span style="font-family: calibri; text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">急</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">救</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">藥</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">品</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">名</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">稱</span><span style="font-family: calibri; text-decoration: underline;"> </span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Aminophylline 250mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Atropine 1mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Diphehydramine 30mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Dopamine 200mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Epinephrine HCI 1mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Calcium Gluconate 10% /10ml</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">20% Glucose 4gm/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Hydrocortisone sodium succinate 100mg/ Vial</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Isoproterenol 0.2mg/ml/amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Norepinephrine Bitartrate</span><span style="font-family: 標楷體;">（</span><span style="font-family: calibri;">Levophed</span><span style="font-family: 標楷體;">）</span><span style="font-family: calibri;">4mg/4ml/amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">0.9% Normal Saline 500ml/bottle</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Sodium Bicarbonate 7% /20ml/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Verapamil 2.5mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Xylocaine 2% 100mg/Vial</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: 標楷體;">★各項急救藥品之數量以符合需要為要求。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">3. </span><span style="font-family: 標楷體;">試驗場所之空間是否足夠</span><span style="font-family: calibri;">? </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.2pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">4. </span><span style="font-family: 標楷體;">試驗場所之地點是否適當</span><span style="font-family: calibri;">?</span><span style="font-family: 標楷體;">應能迅速與醫療網聯繫。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 16.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">5. </span><span style="font-family: 標楷體;">試驗場所是否有足夠之逃生設備及便捷之逃生管道</span><span style="font-family: calibri;">?</span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">6. </span><span style="font-family: 標楷體;">試驗場所應足以處理緊急狀況之搬運。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">7. </span><span style="font-family: 標楷體;">試驗機構內應提供適當休息場所。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><div style="text-align: center;"><table width="690" style="margin: auto auto auto 28.25pt; width: 517.8pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.3pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; padding-right: 1.4pt; height: 26.3pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">項</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">目</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.7pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">執行試驗之人員</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">執行</span><span style="font-family: calibri;">BA/BE</span><span style="font-family: 標楷體;">試驗時，是否有醫師在場。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗主持人或協同醫師是否有參與受試者之採血過程。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">參與執行試驗之每一位人員及負有監督責任者，是否有具備相當之學識、經驗並經訓練而能勝任其職務。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗機構是否有設品質保證人員或單位，負責稽核試驗之各項工作，如試驗藥品之取樣、使用紀錄、給藥、簽到、簽退等。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 28.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">受託執行單位是否有到藥廠瞭解抽樣</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試驗執行之書面作業程序</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">應能迅速與醫療網聯繫，如緊急狀況之運送，是否有制定與醫院緊急聯絡之書面作業程序。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗過程中可能之不良事件，是否有制定並張貼急救或緊急處理之作業程序並詳細紀錄之。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.35pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有以書面制定參與執行試驗之每一位人員之工作職責。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有制訂新進及在職人員應有之訓練程序，以確保每一位試驗操作人員均能勝任其職務。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有制定校正及維護儀器、器具、裝置、儀表及記錄器等之標準作業程序，明確規定其校正、維護之方法及頻率。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">所有儀器查核、維護及校正紀錄是否有保存。若因儀器功能失常所執行之非例行維護工作，其紀錄應記載該缺點發生的時間、原因以及所採取之補救措施。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">重要之書面作業程序是否有明顯張貼。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><p><span style="font-family: calibri;"> </span></p><div style="text-align: center;"><table width="684" style="width: 512.65pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid; height: 26.4pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.4pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="12"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">受試者資料 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">項</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">目</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有受試者抵達及離開試驗場所之時間紀錄</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">受試者於試驗前之活動是否遵守計畫書之納入/排除標準 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">受試者給藥與採樣時間與原計畫是否相符 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">受試者給藥順序是否隨機分配 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有</span><span style="font-family: 標楷體;">受試者出血時間紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">採血時間之紀錄是否完整，並註明是</span><span style="font-family: calibri;">starting time</span><span style="font-family: 標楷體;">、</span><span style="font-family: calibri;">medium time</span><span style="font-family: 標楷體;">或</span><span style="font-family: calibri;"> end time</span><span style="font-family: 標楷體;">、或其他檢品之採集紀錄是否完整 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有</span><span style="font-family: 標楷體;">受試者給藥前及給藥後生命徵象之紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是否有</span><span style="font-family: 標楷體;">受試者總人數、中途退出人數、實際評估人數、不良事件及處理方式等之記載 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之採集次數、時間是否偏離原計畫 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗完成時，</span><span style="font-family: 標楷體;">是否有記錄</span><span style="font-family: 標楷體;">受試者之狀況；及完成後受試者狀況之追蹤（如有需要） </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">11.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">受試者之體檢與參與試驗名稱、日期是否有詳細紀錄並留存備查。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="10"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">檢品之處理 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之溶血紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體編碼方法、存放紀錄(包括時間及狀況)及運送時間紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體的運送方式及保護方法(如以乾冰隔絕空氣之容器)</span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之蒐集、點收、點交是否專人負責 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體運送及處理過程，是否維持適當的溫度</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析前, 檢體是否存放於適當的儲存設備 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">儲存設備是否有溫度紀錄裝置 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">緊急狀況發生時，儲存設備</span><span style="font-family: 標楷體;">是否有</span><span style="font-family: 標楷體;">應變措施 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體間是否有適當之區隔及標示，以避免與其他試驗之檢體混淆 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體之標籤或辨識卡是否完整，並足以預防攜出分析時發生混淆之狀況 </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體;">其他 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 標楷體;">試驗藥品之管理（運送、儲存、試驗結束之處理） </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> </tbody></table></div><p style="text-align: center; line-height: 22pt; layout-grid-mode: char;"> </p><table width="100%" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="background-color: transparent;border: #f0f0f0;"> <div> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">附件二</span> </p> </div> </td> </tr> </tbody></table><span style="font-family: 標楷體; font-size: 20pt;">生體相等性試驗分析場所查核表</span><p style="line-height: 22pt;"><span style="font-family: 標楷體; font-size: 14pt;">公司名稱：</span><span style="font-family: calibri; font-size: 14pt;"> </span><span style="font-family: 標楷體; font-size: 14pt;">地址：</span> </p><div style="text-align: center;"><table width="698" align="left" style="margin: auto 6.75pt; width: 523.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; padding-right: 1.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">規 定 項 目 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">基本資料 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本品及對照品之品管資料（含量測定、單位劑量均一度試驗、溶離率試驗資料）、委託執行書、IRB同意函及試驗主持人、協同醫師、研究主持人同意書</span> </li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本品及對照品之外觀、劑型、劑量、批號、製造日期、有效日期是否同於送審報告</span> </li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">分析之儀器設備</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所所用之主要儀器設備，其類型、品牌、型號是否與送審報告一致，如果不同，請說明之 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">評估主要儀器狀況有無受損，可能致結果不可信賴之情形 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">主要儀器是否有書面操作方法，實驗室人員是否可就近取得。 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">所有分析設備是否有定期校正、維修、保養記錄及是否有不斷電系統 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本試驗是否用到其他特殊設備 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">電子記錄 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本試驗有哪些部分應用到電子資料系統（如未用電子資料系統，此部份可不填） </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 32.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">輸入電腦之資料，其正確性、安全性、及可追溯性如何確認 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">負責輸入、複核、進入系統之人員名單 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">分析方法確效</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所是否能提具資料支持所採之分析方法具專一性 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所是否能提具資料支持所採之分析方法具線性關係 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析人員是否能提具資料<span style="color: black;">顯示</span>最低準確測量濃度(LLOQ )之再現性 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析人員是否能提具資料<span style="color: black;">顯示分析方法的精密度(precision)</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所是否能提具資料<span style="color: black;">顯示藥物回收率（ recovery）</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所是否能提具資料<span style="color: black;">顯示藥物在生物檢體中的安定性</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分析場所是否能提具資料<span style="color: black;">顯示藥物貯存過程如冷藏，對藥物之安定性無不良影響</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> </tbody></table></div><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="697" style="width: 522.5pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; padding-right: 5.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規 定 項 目 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr style="height: 26.25pt;"> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="18"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">檢體分析</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">以隨機方式或特定順序來分析檢體</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">同一受試者其本品及對照品之檢體是否在相同標準曲線、控制組、及相同儀器下進行分析</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">本品及對照品之檢體是否在同一時間及條件下進行分析</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">每一批未知濃度檢體進行分析</span><span style="font-family: 標楷體;">時是否配置有<span style="color: black;">標準線，如果不是，標準線之執行頻率，及是否所有的標準線皆附於報告內</span> </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分析結果是否在標準線的有效範圍內，有無偏離之數值</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分析場所是否訂有數據可接受或排除之標準作業程序(SOP)，所送報告是否遵守此一標準作業程序</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分析過程是否有盲性控制組或非盲性控制組</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">控制組檢體與未知濃度組檢體分析過程是否完全相同</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">空白試驗之生物檢</span><span style="font-family: 標楷體;">體來<span style="color: black;">源</span> </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">藥品標準品的來源，其品質及純度如何確認</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">11.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分析過程儀器所發生</span><span style="font-family: 標楷體;">之特殊狀況及特定條件<span style="color: black;">是否記載於實驗室日誌或紀錄本中</span> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">12.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分析儀器之校正是否訂有標準作業規範及紀錄 </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">13.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分析方法是否同於送審報告，是否所有數值皆有紀錄，如果是重新分析，對照組是否同時進行</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">14.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">送審查之圖譜是否足以代表整個試驗圖譜之品質</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">15.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">檢體重新分析之數值是由舊的或新的標準曲線求得，是否所有重新分析之數值皆檢附於送審之報告 </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">16.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">檢體重新分析之標準，是否所有報告皆遵守此一原則 </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">17.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分析過程所用之試劑，其配製方法是否有完整的紀錄（包括配製日期、保存條件等） </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">18.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">完整層析圖譜（未服藥血清層析圖、加藥血清層析圖、內部標準層析圖、控制組層析圖、每一受試者層析圖等） </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> </tbody></table></div><span style="font-family: calibri, sans-serif; font-size: 14pt;"><br clear="all" style="page-break-before: always;" /></span><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="691" style="width: 518.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; padding-right: 5.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">規 定 項 目 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">自行查核 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">查核結果 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">資料處理與保存</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">有關的試驗記錄及數據應留存於</span><span style="font-family: 標楷體;">適當地點</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">是否設有實驗室日誌，</span><span style="font-family: 標楷體;">是否按日期順序填寫<span style="color: black;">，試驗操作者是否在紀錄上簽名，是否有專人複核簽名</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">原始資料</span><span style="font-family: 標楷體;">及副本<span style="color: black;">是否完整保存</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">原始資料上是否有人簽名及加註日期，</span><span style="font-family: 標楷體;">是否有主管複核並簽名</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">此類資料之保存期限</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">描述實驗資料保存的情形</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">資料不完整（如</span><span style="font-family: 標楷體;">修<span style="color: black;">改或缺乏日期者）的理由</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">簽章</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">最後報告以何種方式給予試驗委託者（書面、傳真、磁片、光碟、燒錄片） </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">如於最後報告發現錯誤，刪除或更改等事項之處理方式 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> </tbody></table></div> |
| 發佈日期 | 2013-12-16 |
| 附件檔案 |