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
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