1.48 Randomization 随机化
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.
为了减少偏倚，采用机遇决定分配的原理将试验对象分配倒治疗组或对照组的过程。
1.49 Regulatory Authorities 管理当局
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.
有权进行管理的基构。在ICH GCP指导原则中，管理当局一词包括审评所提交的临床数据和实施视察的机构（见1.29）。这些机构有时指主管当局。
1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) 严重不良事件（SAE）或严重药品不良反应
Any untoward medical occurrence that at any dose: 发生在任何剂量的任何不幸医学事件： ? results in death, ? － 导致死亡 ? is life-threatening, ? － 危及生命
? requires inpatient hospitalization or prolongation of existing hospitalization, ? － 需要住院治疗或延长住院时间
results in persistent or significant disability/incapacity, or ? － 导致永久或严重的残疾/能力丧失，或 ? is a congenital anomaly/birth defect ? － 先天性异常/出生缺陷
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
（见ICH临床安全性数据管理指导原则，快速报告的定义和标准）
1.51 Source Data 源数据
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).
临床试验中的临床发现、观察或其他活动的原始记录及其可靠副本中的全部资料，他们对于重建和评价试验是必要的。源数据包含在源文件中（原始记录或可靠副本）。
1.52 Source Documents 源文件
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).
原始文件、数据和记录（如医院记录，临床和办公室图标，实验室笔记，备忘录，对象日记卡或评价表，药房发药记录，自动仪器的记录数据，在核对后做为准确副本的可靠复印件或抄件，显微胶片，摄影负片，缩微胶卷或磁介质，X线，对象文件，以及保存在药房、实验室和与参与临床试验的医学技术部门中的记录。
1.53 Sponsor 申办者
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
对一个临床试验的发起、管理和/或财务负责的个人、公用、机构或组织。
1.54 Sponsor-Investigator 申办者－研究者
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. 单独与其他人一起，发起并实施一个临床试验的个人。在他（们）的直接指示下，给对象服用、发给对象或由对象使用试验药品。该术语并不包括除了个人以外的任何人（如不包括一个公司或一个机构）。一个申办者－研究者的义务包括一个申办者和一个研究者两者的义务。
1.55 Standard Operating Procedures (SOPs) 标准操作程序（SOP）
Detailed, written instructions to achieve uniformity of the performance of a specific function. 为达到均一性完成一个特定职责指定的详细书面说明。
1.56 Subinvestigator 次级研究人员
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.
在一个试验单位，在主要研究者指定和监督下的临床试验组中完成与试验有关的重要程序和/或作出与有关试验的重大决定的成员（如同事，住院医生，特别是研究生）。见研究者。
1.57 Subject/Trial Subject 对象/试验对象
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
参加一个临床试验作为试验药品的接受者或作为对照的个人。
1.58 Subject Identification Code 对象识别编码
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. 研究者为每一名受试对象指定的独特识别号码，以保护对象的身份并在研究者报告不良事件和/或其他与试验有关数据时代替对象姓名。
1.59 Trial Site 试验单位
The location(s) where trial-related activities are actually conducted. 真正开展与临床试验有关活动的地方。
1.60 Unexpected Adverse Drug Reaction 非预期的药品不良反应
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).
一种不良反应，其性质或严重程度与现有的产品资料（如一种未批准试验用药品的研究者手册，或包装插入页/一个已经批准药物的产品性能摘要）不符的不良反应（见ICH临床安全性数据管理指导原则：快速报告的定义和标准）。
1.61 Vulnerable Subjects 弱势对象
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 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.
指受到不正当的影响而称为一个临床志愿者的人，他们可能由于期望（无论正当与否）参加试验而伴随的利益，或者拒绝参加会受到等级中资深成员的报复。有等级结构的团体的成员，如医学、药学、齿科或护理专业的学生，附属医院和实验室人员，制药公司的雇员，军人，以及被监禁的人。其他弱势对象包括无可救药的患者，住在福利院利的人，失业者或穷人，处于危急状况的病人，少数民族，无家可归者，流浪者，未成年者，和那些无能力给出知情同意的人
1.62 Well-being (of the trial subjects) 健康（试验对象的）
The physical and mental integrity of the subjects participating in a clinical trial. 参加临床试验对象的体格和精神的完整性。
2. THE PRINCIPLES OF ICH GCP ICHGCP的原则
2.1 Clinical 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). 2.1 临床试验的实施应符合源自赫尔辛基宣言的伦理原则，与ＧＣＰ和适用管理要求一致。
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. 2.2 在开始一个试验之前，应当权衡个体试验对象和社会的可预见风险、不方便和预期的受益。只有当预期的受益大于风险时，才开始和继续一个临床试验。
2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should
prevail over interests of science and society.
2.3 试验对象的权利、安全和健康是最重要的考虑，应当胜过科学和社会的利益。
2.4 The available nonclinical and clinical information on an investigational product should be adequate to
support the proposed clinical trial.
2.4 关于试验用药品可得到的非临床和临床资料应足以支持所提议的临床试验。
2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol. 2.5 临床试验应当有坚实的科学基础，有明确、详细描述的试验方案。
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.
2.6 临床试验的实施应当遵循事先已经得到研究机构审查委员会（ＩＲＢ）/独立的伦理委员会（ＩＥＣ）批准/赞成的试验方案。
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. 2.7 一名合格医生或合格牙医的职责永远是给予对象医疗保健，代表对象作出医学决定。
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). 2.8 参与实施临床试验个每一个人应当在受教育、培训和经验方面都有资格完成他或她的预期任务。
2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation. 2.9 应当在参加临床试验前每一个对象获得自由给出的知情同意书。
2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate
reporting, interpretation and verification.
2.10 所有临床试验资料被记录、处理和储存的方式应当允许资料的准确报告、解释和核对。
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). 2.11 可能鉴别对象身份的记录的保密性应当得到保护，依照适用的管理要求尊重隐私和保密规定。
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.
2.12 试验用药品应当按照适用的药品生产质量管理规范（ＧＭＰ）生产、处理和储存。试验用药品应按照已批准的方案使用。
2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.
2.13 应当建立保证试验各方面质量的程序系统。