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）
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 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
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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
Management: Definitions and Standards for Expedited Reporting).
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1.3 變更（對於臨床試驗計畫 書）
參閱試驗計畫書變更版本。
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
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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 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
可重建稽核過程的文件。
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
紀錄試驗計畫書中要求的資 訊，將每位受試者的情形以印
1.11 Case Report Form (CRF) A printed, optical, or electronic document designed to record all
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刷、光學或電子文件的方式報 告給試驗委託者。
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 來發現或證明研究用藥品在臨 床、藥理與\或其他藥效學作 用；與\或確認研究用藥品的不 良反應；與\或探討研究用藥品 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兩者 為同義。
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, 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
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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）
遵守所有與試驗相關、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 合約
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。
1.17 Contract
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
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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：國內與國外衛生主管 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 constraints
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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 優良臨床試驗規範
（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
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
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被保護。 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。
1.25 Independent
Data-Monitoring Committee (IDMC) (Data and Safety 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
為非試驗的試驗相關人員，且 不受參與試驗人員的不當影 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
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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 獨立倫理委員會依照本指引所 描述藥品優良試驗規範運作
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 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
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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 床試驗相關的檔案、設備、紀
主管機關正式檢閱其認為與臨 床試驗相關的檔案、設備、紀