Contents
Part 3: Examples of Other Sponsor-Required Documens
Part 4: Documenting the Use of Investigational Drugs
Part 5: Summary of Key Points
Part 3: Examples of Other Sponsor-Required Documents 其他赞助商要求的文件示例
In addition to the essential documents included in the GCP guideline, the sponsor may require other documentation. The following lists examples of other documentation that may apply to clinical trials.
除GCP指南中包含的基本文件外，申办方可能需要其他文件。以下列出了可能适用于临床试验的其他文件的示例。
Certificate of Confidentiality 保密证书
A Certificate of Confidentiality provides an additional level of protection for the privacy of participants in alcohol and drug abuse research studies. (For more detailed information on Certificates of Confidentiality, go to the Confidentiality and Privacy module)
保密证书为酒精和药物滥用研究参与者的隐私提供了额外的保护。（有关保密证书的更多详细信息，请转到保密和隐私模块）
Quality Assurance Documents 质量保证文件
Quality assurance documents may include the following:
质量保证文件可能包括以下内容：
Ⅰ、Research site Initiation Activation Form, which indicates that a site is ready to start study enrollement.
Ⅱ、Site visit logs, to record visits to the research site by quality assurance monitors and other personnel.
1、研究点启动激活表，表明研究点已准备好开始研究注册。
2、现场访问日志，记录质量保证监督员和其他人员对研究现场的访问。
Training Documents 培训文件
A training plan and verification of compliance with the training plan, including:
培训计划和培训计划合规性验证，包括：
Ⅰ、Al training documentation form for each staff person
Ⅱ、Documentation of required assessments training per the study training plan.
Ⅲ、Documentation of study–specific training.
Ⅳ、Pertinent certifications for clinical staff implementing a study intervention.
1、每位员工的所有培训文件表。
2、根据研究培训计划，记录所需的培训评估。
3、学习文件——具体培训。
4、实施研究干预的临床人员的相关认证。
Behavioral Therapy Documents 行为治疗文件
Many CTN studies involve behavioral interventions. Behavioral studies may require essential documents different from, or in addition to, those required by GCP guidelines. These documents may include therapy manuals and materials, audio and videotapes of treatment sessions, and other documents specific to the behavioral intervention that is being studied.
许多CTN研究涉及行为干预。行为研究可能需要不同于GCP指南要求的基本文件，或者需要GCP指南要求的附加文件。这些文件可能包括治疗手册和材料、治疗过程的音频和录像带，以及与正在研究的行为干预相关的其他文件。
Source Documents 源文件
Source documents are original documents, data, or records that are created during a clinical study, that relates to the medical treatment and the history of the participant, and from which study data are obtained. Source documents are one type of essential document that is required by GCP guidelines.
源文件是临床研究期间创建的原始文件、数据或记录，与受试者的医疗和病史有关，并从中获得研究数据。源文件是GCP指南要求的一种基本文件。
The purpose of source documents (GCP 8.3.13) is to:
Ⅰ、Document the existence of study participants.
Ⅱ、Substantiate the integrity of the study data collected.
源文件（GCP 8.3.13）的目的是：
一、记录研究参与者的存在。
二、证实所收集研究数据的完整性。
Examples of Source Documents 源文件示例
The following are examples of source documents:
以下是源文档的示例：
Ⅰ、Adverse event and concomitant medication logs
Ⅱ、Reports of diagnostic test results
Ⅲ、Signed and dated Informed Consent Forms
Ⅳ、Participant diaries
Ⅴ、Appointment calendars
Ⅵ、Progress notes
Ⅶ、Paper case report forms (CRFs) on which data are entered directly onto the CRF, rather than extracted from another source document.
1、不良事件及伴随用药记录
2、诊断试验结果报告
3、签署并注明日期的知情同意书
4、参与者日记
5、预约日历
6、进度说明
7、纸质病例报告表（CRF），其数据直接输入CRF，而不是从其他源文件中提取。
Progress Notes 进度说明
These source materials must be readily available and retrievable for quality assurance monitoring and for auditing, for example, by the study sponsor (NIDA) or for inspection by the U.S. Food and Drug Administration (FDA).
这些源材料必须随时可用，并可检索，以进行质量保证监测和审计，例如，由研究发起人（NIDA）或由美国食品和药物管理局（FDA）检查。
The purpose of progress notes is to document participants’ involvement in the study and the study–related care they receive. Both research and clinical staff may complete progress notes.
进度说明的目的是记录参与者参与研究的情况以及他们接受的研究相关护理。研究人员和临床人员都可以完成进度记录。
Progress notes are source documents; and may not be recorded in the study database or sent to the sponsor. Often, progress notes are used on–site to monitor the progress of the study. Another important purpose of progress notes is to substantiate the data recorded in the case report forms (CRFs).
进度说明是源文件；不得记录在研究数据库中或发送给申办方。通常，在现场使用进度记录来监控研究的进度。进度说明的另一个重要目的是证实病例报告表（CRF）中记录的数据。
Progress notes should be concise but should provide enough information that the participant’s study–related activities, and the order in which events occurred, can be easily understood.
进度说明应简洁但提供足够的信息，使参与者的研究相关活动以及事件发生的顺序易于理解。
Progress notes are of two types, both considered to be essential study documents:
进度说明分为两类，都被认为是基本研究文件：
Ⅰ、Clinical notes record information related to the experimental treatment that the participant received during the clinical phases of the study.
Ⅱ、Research notes record information related to the participant's involvement in the research phases (e.g., follow-up assessment visits) of the clinical study.
1、临床记录记录参与者在研究临床阶段接受的实验治疗相关信息。
2、研究记录记录了与参与者参与临床研究研究阶段（如随访评估访问）相关的信息。
Click here for a list of information that should be documented in both clinical and research progress notes.
单击此处查看应记录在临床和研究进展说明中的信息列表。
Click here for a summary of Good Medical Record practices that should always be observed when writing progress notes.
单击此处可获取撰写进度说明时应始终遵守的良好病历做法的摘要。
Case Report Forms 个案报告表格
GCP defines a Case Report Form (CRF) as follows:
“A printed, optical, or electronic document designed to record all of the protocol–required information to be reported to the sponsor on each trial subject” (ICH GCP 1.11)
GCP对病例报告表（CRF）的定义如下：
“设计用于记录所有试验方案的印刷、光学或电子文件——就每个试验对象向申办方报告的所需信息”（ICH GCP 1.11）
Thus, a CRF may be a printed document that a study team member completes in the clinic or an electronic document that is sent directly from a laboratory to the data management center.
因此，CRF可以是研究团队成员在诊所完成的打印文档，也可以是直接从实验室发送到数据管理中心的电子文档。
The purpose of CRFs is to gather study data in a standardized format so that the data can be entered into a computerized database and analyzed. The CRFs record all of the information needed to complete the data analyses used to assess the outcomes of the study.
CRFs的目的是以标准格式收集研究数据，以便将数据输入计算机化数据库并进行分析。CRF记录完成用于评估研究结果的数据分析所需的所有信息。
A CRF is a source document only when study data are entered directly onto the CRF, rather than extracted from another source document (e.g., progress notes).
只有当研究数据直接输入CRF，而不是从另一个源文件（如进度说明）中提取时，CRF才是源文件。
Click to view Clinical Trial Network（CTN） related content
点击查看临床试验网络（CTN）相关内容
CTN–Specific Essential Documents CTN–特定基本文件
CTN investigators are required to maintain a Certificate of Confidentiality, QA, Training, Behavioral Therapy, Source, Progress Note, and CRF documents for CTN studies. Additionally, contact information should be maintained for the following CTN study personnel:
CTN研究人员需要为CTN研究保留保密证书、QA、培训、行为治疗、来源、进度说明和CRF文件。此外，应保存以下CTN研究人员的联系信息：
Ⅰ、Key personnel at the Lead Node.
Ⅱ、Key personnel at the Participating Node.
Ⅲ、Key personnel at the NIDA Center for the Clinical Trials Network (CCTN).
Ⅳ、The NIDA Study Medical Officer and other parties who must be contacted when expedited reporting of an adverse event is necessary.
1、牵头节点关键人员。
2、参与节点的关键人员。
3、NIDA临床试验网络中心（CCTN）的关键人员。
4、NIDA研究医生和其他必须在需要快速报告不良事件时联系的各方。
Part 4: Documenting the Use of Investigational Drugs 记录试验药物的使用情况
21 CFR 312.62 requires investigators to maintain adequate records of the disposition of investigational drugs, including dates, quantities, and use by participants. The investigator must also maintain records of receipt.
21 CFR 312.62要求研究人员保留试验药物处置的充分记录，包括日期、数量和参与者的使用。研究人员还必须保存接收记录。
The following equation may help in understanding the process of accountability for drug disposition:
以下等式可能有助于理解药物处置的责任流程：
Although this equation may look simple, in practice accounting accurately for the disposition of an investigational drug can be quite complicated. The investigator must account for every unit of the investigational product (e.g., tablet, capsule, inhaler).
虽然这个等式看起来很简单，但在实践中，准确地计算研究药物的处置可能相当复杂。研究人员必须说明每一单位的试验产品（如片剂、胶囊、吸入器）。
Let’s take a closer look at what is involved in accounting for every unit of an investigational product.
让我们更仔细地看一下每单位试验药物的核算涉及到什么。
Documentation of the "Amount of Drug Received" 记录“收到的药品数量”
Documentation of the "amount of drug received" must account for:
Ⅰ、The total number of capsules, tablets, etc. in every dosage (e.g., 5 mg, 10 mg).
Ⅱ、Multiple lot numbers.
Ⅲ、The type of packaging in which the medication is delivered (e.g., bulk supply, individual kits).
“收到的药品数量”的文件必须说明：
1、每剂胶囊、片剂等的总量（如5mg、10mg）。
2、多个批号。
3、交付药物的包装类型（如散装供应、单独药盒）。
Documentation of the "Amount of Drug Used" 记录“药物使用量”
Documentation of the "amount of drug used" must account for:
Ⅰ、The amount of medication that each study participant is individually exposed to.
Ⅱ、The total amount of medication consumed by all study participants.
Ⅲ、The amount of medication that is returned by participants (i.e. unused).
Ⅳ、The amount of medication that is wasted (e.g., lost, dropped down the kitchen sink).
“药物使用量”的文件必须说明：
1、每个研究参与者单独接触的药物量。
2、所有研究参与者服用的药物总量。
3、参与者退回的药物量（即未使用）。
4、浪费的药物量（例如，丢失、掉到厨房水槽中）。
Verification of the "Amount of Drug on Hand" 核实“现有药品数量”
Inventory must be taken at regular intervals to verify the "amount of drug on hand." Any discrepancies must be documented.
必须定期清点库存，以核实“库存药品数量”任何差异都必须记录在案。
To ensure proper accountability, a carefully designed plan (or standard operating procedure) must be in place at the beginning of the study to document the disposition of the investigational product at each site. This plan must be adhered to throughout the study and, if necessary, modified to ensure 100% accountability. The investigator’s records of drug disposition must agree with the data submitted to the sponsor.
为确保适当的责任，必须在研究开始时制定一份精心设计的计划（或标准操作程序），以记录每个试验点的试验药物处置情况。在整个研究过程中，必须遵守该计划，如有必要，进行修改，以确保100%的责任。研究人员的药物处置记录必须与提交给申办方的数据一致。
Summary of Key Points
Ⅰ、Every aspect of a clinical study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) standards and with all applicable regulations.
1、必须记录临床研究的各个方面，以获得有用的数据，并证明符合良好临床实践（GCP）标准和所有适用法规。
Ⅱ、GCP guidelines specify the essential documents that must be maintained for every clinical study. These documents are classified according to whether they are normally created before a study begins, while a study is in progress, or after a study is completed or terminated.
2、GCP指南规定了每项临床研究必须保存的基本文件。这些文件根据是否通常在研究开始前、研究进行中或研究完成或终止后创建进行分类。
Ⅲ、Federal regulations require investigators to retain records for 2 years after approval of the investigational drug by the U.S. Food and Drug Administration (FDA) or for 2 years after the study is discontinued and FDA is notified.
3、联邦法规要求研究人员在美国食品和药物管理局（FDA）批准试验药物后保留记录2年，或在研究中止并通知FDA后保留记录2年。
Ⅳ、Sponsors may require specific documentation in addition to the list of essential documents specified by GCP.
4、除GCP规定的基本文件清单外，发起人可能还需要特定文件。
Ⅴ、Source documents are original documents created during a clinical study, from which study data are obtained. The purpose of source documents is to document the existence of study participants and substantiate the integrity of the study data collected.
5、源文件是临床研究期间创建的原始文件，从中获取研究数据。原始文件的目的是记录研究参与者的存在，并证实所收集研究数据的完整性。
Ⅵ、Progress notes document participants’ involvement in the study and the study–related care they receive. Progress notes are used to monitor the progress of the study and substantiate the data recorded in the case report forms (CRFs).
6、进度说明记录了参与者参与研究的情况以及他们接受的研究相关护理。进度说明用于监测研究进展，并证实病例报告表（CRF）中记录的数据。
Ⅶ、The purpose of CRFs is to gather study data in a standardized format so that the data can be entered into a computerized database and analyzed. All of the information needed to complete the data analyses used to assess the outcomes of the study is recorded in the CRFs.
7、CRFs的目的是以标准格式收集研究数据，以便将数据输入计算机化数据库并进行分析。完成用于评估研究结果的数据分析所需的所有信息都记录在CRF中。
