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