Contents
Part 1: Introduction
Part 2: Documentation Requirements in GCP and Federal Regulations
Part 1: Introduction
Proper documentation is critical to the success of a clinical study. Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
正确的文献记录对于临床研究的成功至关重要。必须记录研究的每个方面，以获得有用的数据，并证明符合良好临床实践（GCP）指南和所有适用法规。
This module provides an overview of GCP documentation requirements, requirements in federal regulations, and sponsor required documentation.
本模块概述了GCP文件要求、联邦法规要求以及赞助商要求的文件。
Part 2: Documentation Requirements in GCP and Federal Regulations GCP和联邦法规中的文件要求
Documentation Requirements in Good Clinical Practice Guidelines 良好临床实践指南中的文件要求
Essential documents for the conduct of a clinical study are defined in ICH GCP 8.1 as follows:
"… those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements."
ICH GCP 8.1中定义了进行临床研究的基本文件，如下所示：
“……单独或集体允许对试验的进行和所产生数据的质量进行评估的文件。这些文件用于证明研究者、赞助者和监督者遵守良好临床实践标准和所有适用的监管要求。”
Essential documents may be audited or inspected by quality assurance monitors or by regulatory authorities to confirm the validity of the study and the integrity of the data collected.
基本文件可由质量保证监督员或监管机构进行审核或检查，以确认研究的有效性和所收集数据的完整性。
GCP guidelines list the essential documents (ICH GCP E6 Section 8) that, at a minimum, must be maintained for every clinical study. These documents are to be maintained by the site and the sponsor, and are classified according to the stage of a study at which they are normally created. These documents may be maintained in multiple locations, depending on whether they are stored with regulatory files or as participant documents. The sponsor and the investigator/institution should maintain a record of the location(s) of their respective essential documents, including source documents. Additional documents may be developed and maintained by the sponsor or the sponsor(s) representatives.
GCP指南列出了每项临床研究必须至少保存的基本文件（ICH GCP E6第8节）。这些文件由现场和发起人保存，并根据通常创建这些文件的研究阶段进行分类。这些文件可以保存在多个位置，具体取决于它们是与监管文件一起存储还是作为参与者文件存储。发起人和研究人员/机构应保存其各自基本文件（包括原始文件）的位置记录。发起人或发起人代表可编制和维护其他文件。
BEFORE
Before a Study Begins
The following essential documents must be created and kept on file at study sites before a study begins:
在研究开始之前，必须在研究地点创建并保存以下基本文件：
Ⅰ、Signed protocol and amendments, if any.
Ⅱ、IRB-approved Informed Consent Form and any other written information that will be given to prospective study participants to enable them to make an informed decision about enrolling in the trial.
Ⅲ、Sample case report forms, either electronic or paper.
Ⅳ、Participant recruitment advertisements, if any.
Ⅴ、Documentation that the Institutional Review Board (IRB) is set up in accordance with GCP and that all necessary IRB approvals have been obtained.
Ⅵ、Decoding procedures for blinded trials to document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects' treatment, if applicable.
Ⅶ、Documentation of study personnel's qualifications (e.g., curriculum vitae, professional licenses).
Ⅷ、Documentation of financial agreements and any other arrangements between the parties involved in conducting the study (e.g., investigator(s), institution(s), sponsor, contract research organization).
Ⅸ、Insurance statement, where required, to document that compensation to subject(s) for trial-related injury will be available.
Ⅹ、If the study involves the use of an investigational drug, instructions for handling, dispensing, and tracking the investigational product, as well as shipping records, and a sample of the label to be attached to the investigational product container.
Ⅺ、Investigator's Brochure, when applicable.
Ⅻ、Evidence of notification, approval, or authorization of the protocol and its supporting documentation by regulatory authorities (if required)
XIII、Evidence of approval or certification of facilities that are performing medical or laboratory tests required by the study protocol.
XIV、Normal value(s)/ range(s) for medical, laboratory, and/or technical procedures and tests included in the protocol.
XV、Reports of site initiation visits and qualification visits by quality assurance monitors.
1、签署的协议和修正案（如有）。
2、IRB批准的知情同意书以及将提供给潜在研究参与者的任何其他书面信息，以使他们能够就参加试验做出知情决定。
3、案例报告表样本，电子版或纸质版。
4、参与者招聘广告（如有）。
5、证明机构审查委员会（IRB）是根据GCP成立的，且已获得所有必要的IRB批准的文件。
6、盲法试验的解码程序，以记录在紧急情况下，盲法试验产品的身份如何在不打破盲法的情况下被披露，以供剩余受试者治疗（如适用）。
7、研究人员资格证明文件（如简历、专业执照）。
8、参与研究的各方（如研究人员、机构、赞助人、合同研究机构）之间的财务协议和任何其他安排的文件。
9、保险声明，如有需要，记录受试者因试验相关伤害而获得的赔偿。
10、如果研究涉及试验药物的使用，则应提供处理、配药和跟踪试验药物的说明，以及装运记录，以及贴在试验药物容器上的标签样本.
11、研究人员手册（如适用）
12、监管机构通知、批准或授权协议及其支持文件的证据（如需要）
13、 进行研究方案要求的医疗或实验室试验的设施的批准或认证证据。
14、 协议中包括的医疗、实验室和/或技术程序和测试的正常值/范围。
15、 质量保证监督员的现场启动访问和资格访问报告。
IN PROGRESS
While a Study is in Progress 正在进行的研究
The following are essential documents that should be added to the file while a study is in progress:
以下是在进行研究时应添加到文件中的基本文件：
Ⅰ、Amendments to the Protocol and changes to the case report forms (CRFs), recruitment materials, Informed Consent Form, and Investigator's Brochure.
Ⅱ、Documentation of approval of amendments by the Institutional Review Board (IRB) and regulatory authorities (if required).
Ⅲ、Copies of all reports, including interim and annual reports, sent to the IRB and other regulatory authorities.
Ⅳ、Informed consent forms signed by study participants.
Ⅴ、Signed, dated, and completed CRFs and documentation of any CRF corrections with the signature sheet.
Ⅵ、Documentation of investigational products and trial-related materials shipment.
Ⅶ、Relevant communications, such as letters and meeting notes, that document agreements or discussions about issues including protocol violations, adverse events, the conduct and administration of the study, and all safety information notifications and communications.
Ⅷ、Relevant communications other than site visits, such as letters and meeting notes.
Ⅸ、Reports of interim visits by quality assurance monitors.
Ⅹ、Curriculum vitae for new investigators and sub-investigators.
Ⅻ、Participant screening log, enrollment log, and identification code list.
XIII、Documentation that investigational drugs, if used in the study, have been handled and accounted for as required in the protocol.
XIV、Records of location and identification of retained tissue samples, if any.
XV、Staff signature log, documenting signatures and initials of all persons authorized to make entries and/or corrections to CRFs.
XVI、Updates to CVs, license etc.
1、对方案的修订以及对病例报告表（CRF）、招募材料、知情同意书和研究人员手册的更改。
2、机构审查委员会（IRB）和监管机构（如需要）批准修订的文件。
3、发送给IRB和其他监管机构的所有报告（包括中期报告和年度报告）的副本。
4、研究参与者签署的知情同意书。
5、签署、注明日期并填写完整的CRF以及任何CRF更正的文件以及签名表。
6、研究产品和试验相关材料的装运文件。
7、相关通信，如信函和会议记录，记录有关问题的协议或讨论，包括违反方案、不良事件、研究的进行和管理，以及所有安全信息通知和通信。
8、现场考察以外的相关沟通，如信函、会议纪要等。
9、质量保证监督员的临时访问报告。
10、新调查员和副调查员的简历。
11、原始文件。
12、参与者筛选日志、报名日志、身份代码清单。
13、 证明试验药物（如果在研究中使用）已按照方案要求进行处理和说明的文件。
14、 保留组织样本的位置和标识记录（如有）。
15、员工签名日志，记录所有被授权录入和/或修改crf的人员的签名和首字母。
16、更新简历、许可证等。
AFTER
After a Study is Completed or Terminated 研究完成或终止后
The following are essential documents that should be added to the file after a study is completed or terminated:
以下是研究完成或终止后应添加到文件中的基本文件：
Ⅰ、Documentation that investigational drugs, if used, were handled, accounted for, and returned or destroyed as required in the protocol.
Ⅱ、List of all participants enrolled in the study at the site (completed subject identification code list).
Ⅲ、Reports of closeout visits by quality assurance monitors.
Ⅳ、Final reports to Institutional Review Boards and regulatory authorities.
Ⅴ、Clinical study report, which documents the study’s results, if applicable.
1、研究药物（如使用）按照方案要求进行处理、说明、退回或销毁的文件。
2、现场登记参加研究的所有参与者名单（填写完整的受试者识别码清单）。
3、质量保证监督员的收尾访问报告。
4、向机构审查委员会和监管机构提交的最终报告。
5、临床研究报告，记录研究结果（如适用）。
Documentation Requirements in Federal Regulations 联邦法规中的文件要求
21 CFR 312.62 requires investigators to:
21 CFR 312.62要求调查人员：
Ⅰ、Maintain adequate records of the disposition of investigational drugs.
Ⅱ、Maintain adequate case histories for all participants in studies that involve the use of investigational products.
Ⅲ、Retain records for 2 years after the date a marketing application is approved for the drug for the indication for which is it has been investigated by the U.S. Food and Drug Administration (FDA) or for 2 years after the study is discontinued and the FDA is notified.
Ⅳ、Records of all NIH–sponsored studies must be maintained for at least 3 years after the study ends per NIH policy and for a longer time if required by regulations or local institutional policies. This requirement applies to all research projects, including studies of investigational drugs, behavioral studies, and survey–based studies.
1、保持试验药物处置的充分记录。
2、为所有参与使用试验药物的研究的参与者保留充分的病例记录。
3、在美国食品和药物管理局（FDA）对该药物的适应症进行调查后，在批准该药物的上市申请之日起2年内保留记录，或在该研究终止并通知FDA后保留记录2年。
4、根据NIH政策，所有NIH赞助研究的记录必须在研究结束后至少保存3年，如果法规或当地机构政策要求，则必须保存更长的时间。该要求适用于所有研究项目，包括试验药物研究、行为研究和基于调查的研究。
Click to view Clinical Trial Network（CTN） related content
点击查看临床试验网络（CTN）相关内容
Records of all CTN–sponsored studies must be maintained for at least 3 years after the study ends per NIH policy and for a longer time if required by regulations or local institutional policies. This requirement applies to all research projects, including studies of investigational drugs, behavioral studies, and survey–based studies.
根据NIH政策，所有CTN赞助研究的记录必须在研究结束后至少保存3年，如果法规或当地机构政策要求，则必须保存更长的时间。该要求适用于所有研究项目，包括试验药物研究、行为研究和基于调查的研究。
Of note, most facilities where CTN research is conducted are covered entities that must comply with the HIPAA Privacy Rule. Covered entities are required to account for disclosures (must retain documentation) 6 years from the date of creation on which the accounting is requested. (Reference the Clinical Research and the HIPAA Privacy Rule.)
值得注意的是，大多数进行CTN研究的设施都是必须遵守HIPAA隐私规则的覆盖实体。被覆盖的实体被要求从被要求进行会计核算的创立之日起6年内进行披露(必须保留文件)。(参考临床研究和HIPAA隐私规则)
