排，以及关于财务问题的安排。试验方案可以作为合同的基础。
1.18 Coordinating Committee协调委员会
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. 申办者组织的协调实施多中心试验的委员会。
1.19 Coordinating Investigator协调研究者
An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.
被指定负责协调参加一项多中心试验的各中心研究者工作的一名研究者。
1.20 Contract Research Organization (CRO) 合同研究组织
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.
与申办者订立契约完成一个或多个有关申办者方的试验任务和功能的个人或组织（商业性的，学术的或其他）。
1.21 Direct Access 直接访问
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 of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information. 允许监察、分析、核对和复制任何对于评价临床试验有重要意义的记录和报告。直接访问的任何一方（如国内和国外的管理当局，申办者方的监察员和稽查员）应当受适用管理要求的缺书，采取一切合理的预防措施维护对象身份和申办者资料的保密性。
1.22 Documentation 文件
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.
描述或记录试验的方法、实施和/或结果，影响试验的因素，以及采取的措施等的任何形式的记录（包括但不限于书面、电子、磁性和光学的记录，以及扫描、X射线和心电图）。
1.23 Essential Documents 必需文件
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).
指各自和合在一起允许评价一个研究的执行情况和所得数据的质量文件（见8.实施临床试验的必需文
件）。
1.24 Good Clinical Practice (GCP) 临床试验管理规范（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.
是临床试验设计、实施、执行、监察、稽查、记录、分析和报告的标准，它为数据和所报告结果的可信性和准确性提供了保证，并保护试验对象的权利、完整性和机密性。
1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)
独立的数据监察委员会（IDMC）（数据和安全监察委员会，监察委员会，数据监察委员会）
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. 由申办者设立一个独立的数据监察委员会，它定期对研究进展、安全性数据和有效性终点进行评估，向申办者建议是否继续、调整或停止试验。
1.26 Impartial Witness 公平的见证人
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.
独立与临床试验、不受与试验有关人员的不公正影响的个人。如果对象或对象的合法接受代表人不能阅读，他/她将参与知情同意过程，并向对象阅读提供给她们的知情同意书和其他书面资料。
1.27 Independent Ethics Committee (IEC) 独立的伦理委员会（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.
一个由医学专业人员和非医学专业人员组成的独立机构（研究机构的、地区的、国家的或超国家的审评机构或委员会），其职责是保证参加试验对象的权益、安全性和健康；并通过对试验方案、研究人员、设
施以及用于获得和记录试验对象知情同意的方法和材料的合理性进行审评和批准/提供起促进作用的意见以对这种保护提供公众保证
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.
在不同的国家，独立的伦理委员会的法律地位、组成、职责、操作和适用的管理要求可能不用，但是应当如本指导原则所述，允许独立的伦理委员会按GCP进行工作。
1.28 Informed Consent 知情同意
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.
一个对象在被告知与其作出决定有关的所有试验信息后，资源确认他或她参加一个特定试验的意愿过程。知情同意采用书面的、签字并注明日期的知情同意书。
1.29 Inspection 视察
The act by a regulatory authority(ies) of 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).
管理当局在试验单位、申办者和/或合同研究组织或管理当局认为何时的其他机构对其认为与临床试验有关的文件、设备、记录和其他资源进行的官方审查的活动。
1.30 Institution (medical) （医学）研究机构
Any public or private entity or agency or medical or dental facility where clinical trials are conducted. 实施临床试验任何或私人的实体、代理机构、医学或齿科设施。
1.31 Institutional Review Board (IRB) 机构审评委员会（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. 由医学、科学和非科学成员组成的一个独立机构，其职责是通过对试验方案及其修订本，获得受试对象
知情同意所用的方法和资料进行审评、批准和继续审评，确保一项试验的受试对象的权利、安全和健康得到保护。
1.32 Interim Clinical Trial/Study Report 临床试验/研究中期报告
A report of intermediate results and their evaluation based on analyses performed during the course of a trial. 根据试验进行过程中所做的分析写出的中期结果和评价的报告
1.33 Investigational Product 试验用药品
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.
一种在临床试验中供试验的或作为对照的活性成分或安慰剂的药物制剂。包括一个已上市药品以不同于所批准的方式适用或组合（制剂或包装），或用于一个未经批准的适应证，或用于收集一个已批准用法的更多资料。
1.34 Investigator 研究者
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.
负责在一个试验单位实施临床试验的人。如果在一个试验单位是由一组人员实施试验，研究者指这个组的负责人，也称为主要研究者。见次级研究人员。
1.35 Investigator / Institution 研究者/研究机构
An expression meaning \investigator and/or institution, where required by the applicable regulatory requirements\
表示“符合适用管理要求的研究者和/或研究机构”
1.36 Investigator's Brochure 研究者手册
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). 与试验药品在人类对象中的研究有关的临床和非临床资料的汇编（见7.研究者手册）