藥品優良臨床試驗作業指引（Guidance for Good Clinical Practice）

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藥品優良臨床試驗作業指引

（ Guidance for Good Clinical Practice）

衛生福利部

中華民國 109 年 9 月

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前言

為確保上市藥品之安全性及有效性，藥品登記須有實證及臨床試驗資料為依據。國際醫藥法規協合會（International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH）於1996年發布

「E6 GOOD CLINICAL PRACTICE (GCP)」作為臨床試驗執行與管控之基準，

提供藥品臨床試驗設計、執行、紀錄與報告等實務操作上的倫理與科學及品質標準，為世界各國所參採的國際規範。

因應實務發展所需不斷更新，ICH於2016年公布GCP第二版(ICH E6 R2)，

其中包含一個綜合附錄，以鼓勵在臨床試驗設計，進行，監督，記錄和報告方面實施改進且更有效的方法，同時繼續確保對受試者的保護和試驗結果的可靠性。其目的在於強化臨床試驗之品質管控，以確保受試者的安全與試驗資料之可信度。

我國最初於八十五年公告「藥品優良臨床試驗規範(Good Clinical Practice:

GCP)」，並於九十一年參考ICH E6 GOOD CLINICAL PRACTICE (GCP) ，再

次修訂藥品優良臨床試驗規範。又於九十四年修訂「藥品優良臨床試驗準則」，

規範臨床試驗設計、執行、紀錄與報告之倫理與科學品質，並確保受試者的權利、安全與福祉及臨床試驗數據的可信度，係國內臨床試驗之執行與管理之法規依據。前述準則係依據藥事法第42條所訂定，於一零九年修訂名稱為

「藥品優良臨床試驗作業準則」，作為核發變更及展延藥物許可證之基準。

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為建構與國際協和之藥品臨床試驗管理規範，參據 ICH 於2016年12月修訂之「INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)」訂定本指引，以作前述作業準則之補充說明。本指引係比照ICH E6 (R2) 的呈現方式進行編排，並採中英文並列，

以使含義更清楚。

遵循本指引之標準可確保受試者的權利、安全與福祉，使臨床試驗執行與赫爾辛基宣言的原則相符，並確保臨床試驗數據的可信度，及有助提升臨床試驗執行之品質及效率，本指引未來將參考ICH E6最新文件之制訂而更新修訂，俾供試驗相關人員實務操作之參考。

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目錄

正文---⁸

緒論---⁸

第1章、名辭解釋---¹⁰

第2章、基本原則---²⁸

第3章、人體試驗委員會\獨立倫理委員會---³⁰

3.1、責任---31

3.2、組成、功能及運作---34

3.3、作業程序---35

3.4、紀錄---38

第4章、試驗主持人---³⁸

4.1、試驗主持人的資格與認定---38

4.2、適當的資源---39

4.3、受試者的醫療照護---41

4.4、與人體試驗委員會\獨立倫理委員會之聯繫---42

4.5、試驗計畫書之遵從性---43

4.6、試驗藥品---46

4.7、隨機分配過程及盲性解碼---46

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4.8、試驗之受試者同意書---55

4.9、紀錄和報告---56

4.10、進度報告---58

4.11、安全性通報---59

4.12、試驗提早中止或暫時停止---60

4.13、試驗主持人之結案報告---61

第5章、試驗委託者---⁶²

5.0、品質管理---62

5.1、品質保證及品質管制---66

5.2、受託研究機構---67

5.3、醫療專業人員---68

5.4、試驗設計---68

5.5、試驗管理，數據處理，紀錄保持---69

5.6、試驗主持人之選擇---74

5.7、責任分配---75

5.8、受試者及試驗主持人之報償---75

5.9、財務---76

5.10、向主管機關通知\申請---76

5.11、人體試驗委員會\獨立倫理委員會之審查確認---77

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5.12、試驗藥品的資訊---78

5.13、試驗藥品之製造、包裝、標籤及編碼---78

5.14、試驗藥品之供給及處理---80

5.15、紀錄檢視---82

5.16、安全性資料---83

5.17、藥品不良反應報告---83

5.18、監測---84

5.19、稽核---94

5.20、不遵從性---96

5.21、提早終止或暫停試驗---97

5.22、臨床試驗\研究報告---97

5.23、多機構合作臨床試驗---98

第6章、臨床試驗計畫書及其變更---^---99

6.1、一般資訊---99

6.2、背景資訊---100

6.3、試驗目標及目的---101

6.4、試驗設計---101

6.5、受試者之納入及退出---103

6.6、給藥及處置方式---104

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6.7、療效評估---104

6.8、安全性評估---104

6.9、統計方法---105

6.10、原始數據\文件之直接檢視---106

6.11、品質管制及品質保證---106

6.12、倫理考量---106

6.13、資料處理及紀錄保存---106

6.14、財物及保險---107

6.15、發表著作原則---107

6.16、補充資料---107

第7章、主持人手冊---¹⁰⁷

7.1、緒論---107

7.2、通則---110

7.3、主持人手冊之內容---111

7.4、附錄一---120

7.5、附錄二---120

第8章、執行臨床試驗之必要文件---¹²¹

8.1、緒論---121

8.2、臨床試驗開始前---123

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8.3、臨床試驗執行期間---123 8.4、在試驗完成或終止後---123 第8章之附表---¹²⁴

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正文

緒論 INTRODUCTION

藥品優良臨床試驗作業(Good Clinical Practices, 下稱 GCP)係適用人類受試者參與之臨床試驗，其用於設計、執行、紀錄與報告之倫理與科學品質的國際標準。依循此標準可確保受試者的權利、安全與福祉，使臨床試驗執行與赫爾辛基宣言的原則相符，並確保臨床試驗數據的可信度。

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

ICH GCP 目的係提供歐盟（EU）、日本及美國一致的標準，以促進該等區域之法規主管機關相互接受臨床試驗數據。

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

本指引係參考歐盟、日本、美國、澳洲、加拿大、北歐地區國家及世界衛生組織（WHO）之現行 GCP 所制定。

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

欲向主管機關提交之臨床試驗數據，

應遵從本指引。

This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.

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本指引所採納的原則，亦適用於其他對人類安全與福祉產生影響之臨床研究。

The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

附錄 ADDENDUM

自編撰 ICH GCP 指引以來，臨床試驗的規模、複雜度和成本隨之增加。科技和風險管理的演進，增進試驗效率的機會，亦聚焦相關程序之執行。建立 ICH E6 (R1)時，基本上是以紙本方式記錄臨床試驗，現今使用電子數據記錄及報告，促進其他執行方式之產生。例如，中央監測(系統遠端監測)能提供比以往更大的優勢。

Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.

When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text.

因此，本次修訂 ICH E6 (R2)係為促使應用改進且更有效率的方式進行臨床試驗之設計、執行、監督、紀錄及報告。同時，持續確保受試者保護和試驗結果的可靠性。有關旨在提高臨床試驗品質和效率為目的之電子紀錄及必要文件之標準，亦一併更新。

Therefore, this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to

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increase clinical trial quality and efficiency have also been updated.

參照本指引時，應同時參考其他與臨床試驗相關的 ICH 指引（例如：E2A

（臨床安全性數據管理）、E3（藥品臨床試驗報告）、E7（老年族群）、

E8（臨床試驗一般性原則）、E9（統計指導原則）和 E11（小兒族群）。

This guideline should be read in conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9 (statistical principles), and E11 (pediatric populations)).

本指引增訂的附錄為提供歐盟、日本、美國、加拿大和瑞士一致採納的標準，以促進該等法規主管機關相互接受臨床試驗數據。如果 E6 (R1)及 E6 (R2)附錄之內容間有任何衝突，應優先適用 E6 (R2)附錄。

This ICH GCP Guideline Integrated Addendum provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority.

第 1 章、名辭解釋 (GLOSSARY) 1.1 藥品不良反應

在新藥或其新用法，特別是治療劑量可能尚未確立的未上市前臨床試驗中，所有因藥品產生之有害且未預期反應，無論在任何劑量下，皆視為藥品不良反應。對藥品的反應，指的是不良事件與藥品間至少有合理可能

1.1 Adverse Drug Reaction (ADR)

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be

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性的因果關係，如：無法排除其因果相關性。

關於已上巿的藥品：在正常劑量下，

用於預防、診斷或治療，或為改善生理功能，卻發生有害與未預期的反應。（參閱 ICH 臨床安全性數據管理指引：快速通報之定義及標準）

considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.

Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.2 不良事件

受試者使用藥品後的任何不良情況，

其不一定與該治療有因果關係。因此不良事件可為使用藥品 (試驗藥品) 所產生的任何不良與未預期徵候 (包括檢驗異常)、症狀、或疾病，無論其是否與藥品 (試驗藥品) 有關。（參閱 ICH 臨床安全性數據管理指引：快速通報之定義及標準）

1.2 Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data

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Management: Definitions and Standards for Expedited Reporting).

1.3 變更（對於臨床試驗計畫書）

參閱試驗計畫書變更。

1.3Amendment (to the protocol) See Protocol Amendment.

1.4 相關法規要求

任何有關執行藥品臨床試驗之法律與行政命令。

1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

1.5 同意證明（關於人體試驗委員會\

獨立倫理委員會）

臨床試驗計畫經人體試驗委員會\獨立倫理委員會審查通過，可在人體試驗委員會\獨立倫理委員會、醫療機構、GCP 與相關法規要求下進行。

1.5Approval (in relation to Institutional Review Boards)

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

1.6 稽核

有系統且獨立地檢視臨床試驗相關活動與文件，以決定臨床試驗相關活動的進行、數據紀錄、分析與報告是否均依照試驗計畫書、試驗委託者的標準作業程序、GCP 與相關法規的要求。

1.6 Audit

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.7 稽核證書

稽核員確認已執行稽核的證明。

1.7 Audit Certificate

A declaration of confirmation by the auditor

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that an audit has taken place.

1.8 稽核報告

試驗委託者委託之稽核員所寫的稽核結果書面報告。

1.8Audit Report

A written evaluation by the sponsor's auditor of the results of the audit.

1.9 稽核路徑

可重建事件發生過程的文件。

1.9 Audit Trail

Documentation that allows reconstruction of the course of events.

1.10 盲性/遮蔽

讓參與試驗的一方或多方不知道治療分配的步驟。通常單盲是指受試者不知道治療藥物為何，雙盲是指受試者、試驗主持人、監測者與在某些情況下，數據分析者亦不清楚治療分配為何。

1.10Blinding/Masking

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

1.11 個案報告表

記錄試驗計畫書中要求的資訊，將每位受試者的情形以印刷、光學或電子文件的方式報告給試驗委託者。

1.11 Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

1.12 臨床試驗/研究

任何在人身上執行的研究，用來發現或證明試驗藥品在臨床、藥理與\或其他藥效學作用；與\或確認試驗藥品的不良反應；與\或探討試驗藥品的吸收、分佈、代謝、與排

泄，以確認其安全性與\或療效。臨床試驗與臨床研究為同義字。

1.12 Clinical Trial/Study

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption,

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distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

The terms clinical trial and clinical study are synonymous.

1.13 臨床試驗/研究報告

於人身上的治療、預防或診斷製劑之臨床試驗的書面記載。其中有關臨床與統計的敍述、呈現與分析，已整合成一份完整報告書。（參閱 ICH 指引

「藥品臨床試驗報告之格式及內容」）

1.13 Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).

1.14 對照組（藥品）

臨床試驗中做為參考比較的藥品為試驗藥品、已上巿藥品（即主動控制）

或安慰劑。

1.14 Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

1.15 遵從性（與試驗相關）

遵從所有與試驗相關、GCP 與相關法規要求。

1.15 Compliance (in relation to trials) Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

1.16 保密

避免將試驗委託者的機密資料或受試者的身分洩露給未經授權的人員。

1.16 Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

1.17 契約 1.17 Contract

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參與的雙方或多方人員，簽署書面並載明日期的協定，包括工作內容與義務甚至財務事項的安排。試驗計畫書可作為契約的基礎。

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

1.18 協調委員會

試驗委託者可成立委員會，以協調多機構臨床試驗的執行。

1.18 Coordinating Committee

A committee that a sponsor may organize to coordinate the conduct of a multicenter trial.

1.19 協調試驗主持人

多機構合作臨床試驗的試驗主持人之一，主要負責協調多機構臨床試驗中不同試驗機構之試驗主持人。

1.19 Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

1.20 受託研究機構

和試驗委託者簽約的個人或機構 (商業、學術、或其他)，執行試驗委託者部份或更多與試驗相關的任務與職責。

1.20 Contract Research Organization (CRO)

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.

1.21 直接檢視

為評估臨床試驗而准予檢閱、分析、

證明與再造重要的紀錄與報告。任何直接可檢視的團體 (例如：國內與國外主管機關、試驗委託者與稽核員) ，應在相關法規要求的約束內採取合理的預防措施，來維持受試者身分與試驗委託者專利資料的機密性。

1.21Direct Access

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the

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constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information.

1.22 建檔

所有文件有關描述或記錄試驗的方法、執行與\或結果、影響試驗的因素與所採取的行動 (可用任何形式，不限於書面、電子與光學紀錄；掃瞄，

X-光與心電圖)。

1.22 Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

1.23 必要資料

可用來評估試驗的執行與數據品質的資料（參閱 ICH E6(R2) 第 8 章執行臨床試驗的必要資料）。

1.23 Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).

1.24 藥品優良臨床試驗作業（GCP）

臨床試驗設計、執行、監測、稽核、

紀錄、分析、報告之標準，可確保數據與所報告的結果均為可信與正確，

受試者的權利、完整性、與身份機密均被保護。

1.24 Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

1.25 獨立數據監測委員會（數據與安全性監測小組、監測委員會、數據監

1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety

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測委員會）試驗委託者設立的獨立數據監測委員會用來定期評估試驗進度、安全性數據與重要的療效指標，

並建議試驗委託者是否繼續、修正或停止試驗。

Monitoring Board, Monitoring Committee, Data Monitoring Committee)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

1.26 公平見證人

為非試驗相關人員，且不受參與該試驗之相關人員的不當影響，假若受試者或受試者法定代理人不識字，其會參與受試者同意書簽署過程並閱讀受試者同意書與其他提供給受試者的書面資料。

1.26 Impartial Witness

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

1.27 獨立倫理委員會

由具醫學\科學背景之專業人員與非醫學\非科學背景之會員組成的獨立團體 (審查小組或委員會、機構的、

區域的、國家的或超國家的)，其責任為保護受試者的權利、安全與福祉。

審查試驗計畫書、包括試驗主

持人的資格、設備、與要給受試者簽署受試者同意書之相關文件，並核准

\提出贊同意見。儘管獨立倫理委員會的法律狀態、組成、運作與法規要求，

每個國家可能不同，但應能讓獨立倫

1.27 Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well- being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the

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理委員會依照本指引所描述藥品優良臨床試驗作業運作。

由具醫學專業及非醫學專業人員所組成之獨立團體（一個審查小組或委員會，不論是機構的、區域的、國家的或跨國的），其職責為確保參與試驗之受試者，其權利、安全與福祉受到保護，並藉由包括對試驗計畫書、

試驗主持人、試驗機構之適當性及用於取得與記錄受試者告知後同意之方法與文件進行審查及核准，向大眾確保前揭保護之落實。

有關獨立倫理委員會之法律地位、組成、功能、運作方式及法律要求，各國可能有所不同，但應允許獨立倫理委員會在符合本指引內容下採取行動。

suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.

1.28 受試者同意書

在告知受試者並讓其了解將參與之臨床試驗的相關訊息，與決定是否參與試驗的所有情況後，其自願確認他或她願意參加試驗的過程。受試者同意書應使用書面格式，並經簽署及載明日期。

1.28 Informed Consent

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

1.29 查核

主管機關正式檢閱其認為與臨床試

1.29 Inspection

The act by a regulatory authority(ies) of

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驗相關的檔案、設備、紀錄、與其他可能在試驗機構、試驗委託者與\或受託研究機構之資源，或其他主管機關認為與臨床試驗相關之資源。

conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

1.30 醫療機構

任何執行臨床試驗的公立或私立機構包括醫學或牙醫設施。

1.30 Institution (medical)

Any public or private entity or agency or medical or dental facility where clinical trials are conducted.

1.31 人體試驗委員會

由具醫學、科學及非科學背景之成員所組成的獨立團體，其職責在於對試驗計畫書與其變更，以及取得與記錄受試者告知後同意之方法與文件進行審查、核准及持續審查，以確保受試者之權利、安全與福祉受到保護。

1.31

Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well- being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

1.32 臨床試驗/研究期中報告

執行臨床試驗期間，所進行的分析結果與評估報告。

1.32 Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed

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during the course of a trial.

1.33 試驗藥品

臨床試驗中用來試驗之藥品或當做參考之活性成分製劑或安慰劑，包括已上巿藥品使用於與其核准劑型不同的用途或裝配(配方或包裝)或使用於尚未核准的適應症或用於獲得有關核准用途的進一步資料。

1.33 Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

1.34 試驗主持人

在試驗機構執行臨床試驗的負責人。

若試驗機構中以團隊的方式執行試驗，則該團隊的負責人為試驗主持人，亦可稱為總主持人。亦可參閱協同試驗主持人。

1.34 Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.

1.35 試驗主持人\機構

指受相關法規要求的試驗主持人與\

或醫療機構。

1.35 Investigator/Institution

An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements".

1.36 主持人手冊

有關用於人身上的相關研究之試驗藥品之臨床與非臨床數據的編輯物。

（參閱第７章「主持人手冊」）。

1.36 Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator's Brochure).

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1.37 法定代理人

法律授權下可代替受試者同意參與臨床試驗的個人、法人的或其他的團體。

1.37 Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

1.38 監測

監督臨床試驗進度與確保臨床試驗有依照臨床試驗計畫書、標準作業程序、GCP 與相關法令規定之行為。

1.38 Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

1.39 監測報告

在每次依照試驗委託者所訂定的標準作業程序，訪視試驗機構與\或溝通其他與試驗相關的事情後，試驗監測者提供給試驗委託者的書面報告。

1.39 Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs.

1.40 多機構臨床試驗

同一份試驗計畫書，由多個試驗機構與多位試驗主持人共同執行的臨床試驗。

1.40 Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

1.41 非臨床試驗

不在人類身上執行的生物醫學研究。

1.41 Nonclinical Study

Biomedical studies not performed on human subjects.

1.42 意見（與獨立倫理委員會相關）

獨立倫理委員會所提出的決議與\或

1.42 Opinion (in relation to Independent Ethics Committee)

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建議。 The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

1.43 原始醫療紀錄參閱原始文件。

1.43 Original Medical Record See Source Documents.

1.44 試驗計畫書

描述臨床試驗的目的、設計、方法、

統計考量、與編制的文件。通常試驗計畫書亦提供試驗的相關背景與理論，也可能由其他參考資料提供。在 ICH GCP 中，試驗計畫書此一名詞包含試驗計畫書變更。

1.44 Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.

The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

1.45 試驗計畫書變更

有關試驗計畫書變更或正式聲明的書面文件。

1.45 Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol.

1.46 品質保證

為確保臨床試驗執行與試驗數據的產生、紀錄、報告均符合 GCP 與相關法規要求所建立的計畫性和系統性活動。

1.46 Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 品質管制

在品質保證系統內，用來證明試驗相關活動品質均已符合要求的操作技術與活動。

1.47 Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for

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quality of the trial-related activities have been fulfilled.

1.48 隨機分配

用機率來分派受試者接受治療藥品或對照藥品治療以減少偏差的過程。

1.48 Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

1.49 主管機關

有管理權利的單位。在本指引中，主管機關包含審查臨床數據與執行查核 (參閱 1.29) 的主管機關。

1.49 Regulatory Authorities

Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

1.50 嚴重不良事件

服用試驗藥品任何劑量所發生之不幸事件：包括死亡、危及生命、導致病人住院或延長住院時間、造成永久性殘疾、先天性畸形。（參閱 ICH 臨床安全性數據管理指引：快速通報之定義及標準）

1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose:

- results in death, - is life-threatening,

- requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant

disability/incapacity, or

- is a congenital anomaly/birth defect

(see the ICH Guideline for Clinical Safety

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Data Management: Definitions and Standards for Expedited Reporting).

1.51 原始數據

臨床發現、觀察、或其他相關重建與評估的原始紀錄與經確認的副本資料。原始數據包含在原始文件 (原始紀錄或經確認無誤的副本)中。

1.51 Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

Source data are contained in source documents (original records or certified copies).

1.52 原始文件

最初的文件、數據與紀錄 (例如：醫院病歷、臨床與辦公室紀錄、實驗室筆記、備忘錄、受試者日記或評估明細表、藥局處方紀錄、自動化機器所記錄的數據、經證明無誤與完整的副本或謄本、縮影單片、攝影底片、微膠片或核磁媒介、X 光片、患者檔案、

保留在藥局、實驗室與參與臨床試驗之醫療技術部門的紀錄)。

1.52 Source Documents

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

1.53 試驗委託者

負責臨床試驗的啟動、管理與\或財務的個人、公司、機構或組織。

1.53 Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or

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financing of a clinical trial.

1.54 試驗委託者－試驗主持人

單獨或與其他人共同開始與執行臨床試驗的個人。在其直接指示下，試驗藥品可供應、調劑或給受試者使用。試驗委託者-試驗主持人並不包括任何非單獨個體 (例如：不包括企業或政府機構)。其必須同時負起試驗委託者和試驗主持人的責任。

1.54 Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

1.55 標準作業程序

為使某特定功能有一致性表現之詳細書面說明。

1.55 Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

1.56 協同試驗主持人

醫療機構受試驗主持人指派與監督去執行試驗相關重要步驟與做試驗相關重大決策之個人 (例如：專員、

住院醫師、學術研究員)。亦請參閱試驗主持人。

1.56 Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

1.57 受試者/試驗受試者

參加臨床試驗而接受試驗藥品或對照藥品的個人。

1.57 Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

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1.58 受試者身份代碼

試驗主持人指定給每位受試者的獨特辨識碼，其可用來保護受試者的身份。當試驗主持人要報告不良事件與

\或其他試驗相關的數據時，可用於代替名字。

1.58 Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

1.59 試驗地點

實際執行與試驗相關活動之地點。

1.59 Trial Site

The location(s) where trial-related activities are actually conducted.

1.60 未預期藥品不良反應

本質或嚴重程度不同於現有藥品資訊（例如：未上巿試驗藥品之主持人手冊或已上巿藥品之仿單/藥品特性摘要）之藥品不良反應（參閱 ICH 臨床安全性數據管理指引：快速通報之定義及標準）。

1.60 Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

1.61 易受傷害受試者

可能會因為受參與試驗之預期利益，

或拒絶參加可能會遭階級制度中資深人員報復之不當影響而被迫自願參加臨床試驗的受試者。例如：醫療階級團體架構中的會員，例如：醫學系、藥學系、牙醫系與護理系學生、

附屬醫院與實驗室人員、製藥界的員

1.61Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a

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工、軍人、遭拘留的犯人。其他易受偒害的受試者包括絶症患者、安置在護理之家的人、失業或貧窮人家、發生危急情況的人、弱勢人種、無家可歸者、遊牧民族、難民、少數民族與自己無法給予同意的人。

group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention.

Other vulnerable subjects include patients with

incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

1.62 受試者的福祉

參與臨床試驗之受試者其身體與心理之健全。

1.62 Well-being (of the trial subjects) The physical and mental integrity of the subjects participating in a clinical trial.

附錄 ADDENDUM

1.63 經認證的副本

係指經認證（即已加註日期之簽名或係經認證程序）的原始紀錄副本（不論所使用的紀錄媒介為何），並具備與原始紀錄相同的資訊，包括前後文、內容及架構。

1.63Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

1.64 監測計畫

係指描述臨床試驗監測之策略、方法、責任及要求的文件。

1.64 Monitoring Plan

A document that describes the strategy, methods, responsibilities, and requirements

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for monitoring the trial.

1.65 電腦系統的驗證

係指就電腦化系統的特定要求進行建置和記錄的過程，從系統設計到停用或轉換新系統間都能持續落實。驗證方法應基於風險評估，考量系統的預期用途及系統可能影響受試者保護及試驗結果可信度的潛在風險。

1.65Validation of Computerized Systems A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system.

The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

第 2 章、基本原則 (THE PRINCIPLES) 2.1 臨床試驗之執行應符合赫爾辛基宣言的倫理原則，並與 GCP 及相關法規要求一致。

2.1Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

2.2 在試驗開始前，應權衡對個別之受試者和整體社會所造成可預期的危險、不便與預期效益。只有在預期效益超過風險時，才應開始並持續此試驗。

2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

2.3 受試者之權利、安全及福祉是最重要之考量，並應優先於科學及社會之效益。

2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over

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interests of science and society.

2.4 目前已知有關試驗藥品之非臨床及臨床資料，應能適當地支持所提出的臨床試驗。

2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

2.5 臨床試驗應有科學根據，臨床試驗計畫書應清楚及詳盡的描述。

2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

2.6 試驗應依照經主管機關或人體試驗委員會\獨立倫理委員會核准\贊同意見之試驗計畫書執行。

2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

2.7 給予受試者之醫療照顧及為醫療決策為合格醫師或牙醫師的責任。

2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

2.8 每一位參與試驗執行之人員，應有符合工作資格之教育、訓練及經驗。

2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

2.9 受試者參與試驗前，應獲得其自願給予之受試者同意書。

2.9

Freely given informed consent should be obtained from every subject prior to clinical trial participation.

2.10

所有臨床試驗資料應予記錄、處理及貯存，以供確實報告、呈現及確認。

2.10

All clinical trial information should be recorded, handled, and stored in a way that

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附錄

此原則適用本指引中所指之紀錄，不論其所使用之媒介為何。

allows its accurate reporting, interpretation and verification.

ADDENDUM

This principle applies to all records referenced in this guideline, irrespective of the type of media used.

2.11

應保護可辨認受試者身分之紀錄的機密性，符合相關法規對隱私及機密之規定。

2.11

The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

2.12

試驗藥品的製造、處理及貯存應符合 GMP。試驗藥品的使用應遵從已核准之試驗計畫書。

2.12

Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

2.13

試驗應採用所有能確保其品質的規範及程序。

附錄

這些系統應著重於確保受試者保護及試驗結果可信度之面向。

2.13

Systems with procedures that assure the quality of every aspect of the trial should be implemented.

ADDENDUM

Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.

第 3 章、人體試驗委員會\獨立倫理委員會(INSTITUTIONAL REVIEW

藥品優良臨床試驗作業指引 （Guidance for Good Clinical Practice）