ICH-GCP 10.1 Roles & Responsibilities（1）
Part 1: IntroductionPart 2: Responsibilities by Role -- 1
Part 3: Summary of Key Points
Many individuals and groups are involved in conducting a clinical study. The central roles are those of the Sponsor and Principal Investigator, as defined by Good Clinical Practice (GCP) guidelines.
许多个人和团体参与了临床研究。根据良好临床实践（GCP）指南的定义，中心角色是 发起人 和 主要研究者 。
There are additional roles and responsibilities defined for other individuals and groups whose work is essential to the proper conduct of a clinical study. How these roles are referenced, may vary from one research network to another.
另外还 为其他个人和团体规定了额外的角色和责任 ，他们的工作对临床研究的正确进行至关重要。这些角色的引用方式，在不同的研究网络中可能有所不同。
This module will:
Ⅰ、Discuss the roles and responsibilities of the Sponsor, and Principal Investigator as outlined in the GCP guidelines.
Ⅱ、Briefly describe how these roles and responsibilities are fulfilled in clinical studies.
Ⅲ、Discuss the roles and responsibilities of other individuals and groups involved in studies.
本单元将：
1、讨论GCP指南中概述的发起人和主要研究者的角色和责任。
2、简要描述这些角色和职责在临床研究中是如何履行的。
3、讨论参与研究的其他个人和团体的角色和责任。
The following is a summary of responsibilities, as outlined in the GCP guidelines according to role.
以下是GCP指南中根据角色概述的职责摘要。
Central Roles: Sponsor、Principal Investigator、Other Roles、Research Site Staff
中心角色： 发起人、主要研究者、其他角色、研究现场工作人员
All NIH–supported multicenter Phase III clinical trials must have an independent Data and Safety Monitoring Board (DSMB). This requirement applies to both studies of drug therapies and to behavioral studies.
所有NIH支持的多中心III期临床试验必须有一个 独立的数据和安全监测委员会 (DSMB)。这一要求既适用于 药物治疗研究 ，也适用于 行为研究 。
Members of each DSMB include experts in the disease area, treatment, clinical trial design, biostatistics, and research ethics. The DSMBs are appointed by and report to the sponsor. Their role is to:
每个DSMB的成员包括 疾病领域、治疗、临床试验设计、生物统计学和研究伦理方面的专家 。DSMB由发起人任命并向发起人报告。他们的作用是：
Ⅰ、Protect participant safety by being familiar with the study, proposing appropriate analyses, and reviewing outcome and safety data as they become available.
Ⅱ、Ensure study integrity by reviewing data on issues such as participant enrollment, site visits, study procedures, completion of forms, data quality, losses to follow-up, and other measures of adherence to the study protocol.
Ⅳ、Monitor adverse events and recommend changes in the protocol or operation of the study if necessary. This monitoring function is over and above the oversight traditionally provided by the IRB and is particularly important for multicenter research studies.
1、通过 熟悉研究 ， 提出适当的分析 ，并 审查结果 和 安全数据 来保护参与者的安全。
2、通过 回顾参与者登记、现场访问、研究程序、填写表格、数据质量、随访损失 和 其他遵守研究方案的措施 等问题的数据，确保研究的完整性。
3、 监测不良事件，必要时建议对研究方案或操作进行修改 。这种监测功能超越了传统上由IRB提供的监督，对多中心研究尤其重要。
Click here to see the NIH policy document on data and safety monitoring.
单击此处查看NIH关于数据和安全监控的政策文件。
The Sponsor is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and documented in compliance with the protocol, GCP, and regulatory requirements.
申办方负责 实施和维护质量保证和质量控制系统 ，以确保按照方案、GCP和监管要求开展和记录研究。
The Sponsor is responsible for designating appropriately qualified medical personnel to advise on trial- related medical questions or problems.
申办方负责指定适当的合格医务人员，就试验相关的医疗问题提供建议。
The Sponsor is responsible for designating qualified individuals to carry out all stages of the study process, including:
发起人负责指定合格人员执行研究过程的所有阶段，包括：
Ⅰ、Designing the protocol.
Ⅱ、Supervising the overall conduct of the study.
Ⅲ、Managing and verifying the study data.
Ⅳ、Ensuring the safety and rights of human participants.
Ⅴ、Monitoring study performance.
Ⅵ、Planning and conducting the statistical analyses.
Ⅶ、Preparing study reports.
1、协议设计。
2、监督研究的总体开展。
3、管理和验证研究数据。
4、确保人权参与者的安全和权利。
5、监测学习成绩。
6、规划和进行统计分析。
7、编写研究报告。
The Sponsor may transfer any or all of the Sponsor’s trial-related duties and functions to a Contract Research Organization (CRO). However, the ultimate responsibility for the quality and integrity of the trial data always resides with the Sponsor. Any trial-related duties and functions that are transferred to and assumed by a CRO are specified in writing.
赞助商可将其任何或所有与试验相关的职责和职能移交给合同研究组织 （CRO）。然而，试验数据的质量和完整性的最终责任始终在于赞助商。移交给首席检察官并由首席检察官承担的任何审判相关职责和职能均以书面形式规定。
While studies have a Lead Investigator with primary responsibility over the entire trial, this individual is often the Principal Investigator (PI) at the lead research site and has responsibility over the conduct of a clinical study at that site. For multicenter trials, there are a number of research sites, each with its own Principal Investigator with oversight responsibility and staff involved in the conduct of a study.
虽然研究中 有一名主要研究者对整个试验负主要责任 ，但此人 通常是主要研究地点的主要研究者（PI） ， 并负责在该地点进行临床研究 。对于多中心试验，有许多研究点，每个研究点都有自己的负责监督的主要研究者和参与研究的工作人员。
The PI retains ultimate oversight responsibility even when specific tasks are delegated to other site research staff. Additionally, PI responsibilities include:
即使将特定任务委托给 其他现场研究人员 ， PI仍保留最终监督责任 。此外，PI的职责包括：
Ⅰ、Documenting the delegation of study responsibilities to qualified and adequately trained research staff.
Ⅱ、Supervising study performance and overseeing the performance of study staff at the research sites.
Ⅲ、Ensuring that:
i、Participants’ well-being and safety are protected.
ii、All study procedures are conducted at the research sites in accordance with the protocol and GCP.
Ⅳ、Preparing a communication plan for all staff involved in the study.
Ⅴ、Overseeing Investigational product accountability.
1、将 研究责任委托 给合格且经过充分培训的研究人员。
2、 监督研究绩效 ，监督研究现场研究人员的绩效。
3、确保：
（1） 参与者的福利和安全受到保护 。
（2） 所有研究程序均按照方案和GCP在研究现场进 行。
4、为参与研究的所有员工制定 沟通计划 。
5、 监督试验产品的责任 。
Of note, the PI must sign the protocol signature page in that capacity. If the study is being conducted under an Investigational New Drug (IND) application, the PI must also sign Form FDA 1572 .
注意，PI必须以该身份对协议签名页进行签名。如果研究是在研究新药（IND）申请下进行的，PI还必须签署FDA 1572表。
Qualifications and Experience (ICH GCP 4.1)
The PI must:
Ⅰ、Be qualified by education, training, and experience to assume responsibility for the proper conduct of the study.
Ⅱ、If the study involves the use of an investigational product, be thoroughly familiar with the appropriate use of that product as described in the study protocol.
Ⅲ、Be aware of and remain in compliance with GCP and applicable regulatory requirements.
Ⅳ、Maintain a list of qualified persons to whom he or she delegates significant study-related duties.
PI必须：
1、通过 教育、培训和经验 ，有资格承担正确开展研究的责任。
2、如果研究涉及使用试验产品，则应完全熟悉研究方案中所述的该产品的适当使用。
3、了解并遵守GCP和适用的监管要求。
4、 保存一份合格人员名单 ，他或她将重要的学习相关职责委托给这些人员。
All study participants should receive appropriate medical care both for study-related adverse events and for all medical conditions unrelated to study participation.
对于与研究相关的不良事件和与研究参与无关的所有医疗状况，所有研究参与者都应接受适当的医疗护理。
Ⅰ、A qualified physician affiliated with the study should be responsible for all study-related medical decisions.
Ⅱ、The participant’s primary care physician should be informed about the participant’s involvement in the study, provided that the participant:
i、Has a primary care physician.
ii、Agrees that the primary care physician may be informed.
1、参与研究的合格医师应对所有与研究相关的 医疗决策 负责。
2、应将参与者参与研究的情况告知参与者的 初级保健医生 ，前提是参与者：
（1）有一位初级保健医生。
（2）同意可以通知初级保健医生。
The PI is identified to the designated IRB. Before and during a study, the PI must comply with all requirements of the designated Institutional Review Boards (IRBs). A study may not begin prior to obtaining IRB approval. (See material regarding the Investigators’ responsibilities to the IRB from the Institutional Review Boards module .)
PI被标识为指定的IRB。 在研究之前和研究期间，PI必须遵守指定机构审查委员会（IRB）的所有要求 。在获得IRB批准之前，不得开始研究。（参见机构审查委员会模块中关于调查人员对IRB的责任的材料）
The PI is responsible for ensuring that the study is conducted in compliance with the research protocol . He or she should ensure that all protocol violations are identified, documented, and reported in accordance with sponsor and IRB requirements. Repeated protocol violations may indicate that protocol amendments, procedural changes, or additional training are needed.
PI负责确保研究按照研究方案进行。他或她应确保根据 赞助商和IRB的要求识别 、 记录和报告所有违反协议的行为 。 反复违反协议可能表明需要修改协议、更改程序或进行额外培训 。
If the study involves the use of an investigational product, the PI is responsible for ensuring that the investigational product is used only in accordance with the study protocol and federal regulations; and that accountability of the investigational product is maintained. (See related material from the Investigational New Drugs module.)
如果研究涉及使用试验药物， PI负责确保试验药物仅按照研究方案和联邦法规使用 ； 并维持试验药物的责任 。（参见研究新药模块的相关资料）
For clinical investigations that use controlled study drug, the PI may be required to have a medical license. When the PI is not required to have a medical license, responsibility for receiving or administering certain drugs, reviewing safety events, and making independent medical decisions is delegated to qualified medical personnel, such as a physician, physician’s assistant, nurse practitioner , or other qualified/licensed medical professional. These delegated responsibilities are documented in the site’s delegation of responsibilities log, and the staff assigned may serve as a sub-investigator. Consult local regulations and oversight authorities on medical license requirements for conducting research using controlled drug.
对于使用对照研究药物的临床研究，PI可能需要有 医疗许可证 。当PI无需持有医疗许可证时，接收或管理某些药物、审查安全事件和作出独立医疗决定的责任将委托给合格的医疗人员，如医生、医师助理、护士或其他合格/持证的医疗专业人员。这些委派的职责记录在现场的职责委派日志中，指派的工作人员可以担任副调查员。 关于使用受控药物进行研究的医疗许可要求，请咨询当地法规和监督机构。
The PI is responsible for ensuring that the study’s procedures, if any, for randomization and blinding are followed.
PI负责确保遵守研究的随机化和盲法程序（如有）。
The PI is responsible for ensuring that procedures for obtaining and documenting informed consent comply with GCP and with the ethical principles originating in the Declaration of Helsinki.
PI负责确保获取和记录知情同意的程序符合GCP和源自《赫尔辛基宣言》的道德原则。
The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of all study data that are reported to the Sponsor.
PI负责确保向申办方报告的 所有研究数据的准确性、完整性、易读性和及时性 。
The PI should provide written reports on the status of the study to the Sponsor and IRB when and as often as required to do so at each institution where the study is conducted.
PI应在进行研究的每个机构中，在必要的时候，向 主办方和IRB 提供关于研究状态的书面报告。
All serious adverse events must be reported immediately to the Sponsor. The PI must also comply with regulatory requirements to report serious adverse events to the IRB and regulatory authorities.
所有严重不良事件必须立即报告发起人 。PI还必须遵守监管要求，向IRB和监管机构报告严重不良事件。
On completion of the study, the PI is responsible for providing:
Ⅰ、All required reports to the Sponsor and regulatory authorities.
Ⅱ、A summary of the study outcome to the Institutional Review Board.
Ⅲ、Records and reports are discussed in greater detail in the Documentation and Record Keeping module.
Ⅳ、Serious adverse events are discussed in the Participant Safety and Adverse Events module.
研究完成后，PI负责提供：
1、 向发起人和监管机构提交的所有必要报告 。
2、向机构审查委员会提交研究 结果摘要 。
3、记录和报告在 文件和记录保存模块中有更详细的讨论 。
4、 严重不良事件 在参与者安全和不良事件模块中讨论。
If the study is suspended or stopped early for any reason, the PI is responsible for:
如果研究因任何原因提前暂停或停止，PI负责：
Ⅰ、Promptly informing all study participants.
Ⅱ、Ensuring that all participants receive appropriate therapy and follow-up.
Ⅲ、Complying with all requirements to inform regulatory authorities.
1、 及时通知所有研究参与者 。
2、确保所有参与者接受适当的 治疗和随访 。
3、遵守通知 监管机构 的所有要求。
The investigator convenes a Protocol Team to assist with all aspects of the operation of the study. In addition to the responsibilities listed under Principal Investigator, other responsibilities represented on the Protocol Team usually include, but are not limited to, Quality Assurance, Training, and Regulatory Affairs.
研究者召集一个方案小组，协助研究操作的各个方面。除主要研究者项下列出的职责外，方案团队的其他职责 通常包括但不限于质量保证、培训和监管事务 。
Quality Assurance (QA) staff is responsible for:
Ⅰ、Reviewing the protocol to check for inconsistencies and problematic wording that will increase the likelihood of protocol violations.
Ⅱ、Reviewing monitoring reports of site visits to ensure that all identified issues are addressed in an appropriate and timely fashion and are communicated to the investigative team.
Ⅲ、Conducting site visits on the behalf of the Sponsor as needed.
1、 审查协议 ，检查不一致和有问题的措辞是否会增加违反协议的可能性。
2、 审查现场视察的监测报告 ，以确保以适当和及时的方式解决所有确定的问题，并将其传达给调查小组。
3、根据需要 代表主办方进行现场考察 。
Regulatory Affairs staff is responsible for:
Ⅰ、Writing the study informed consent documents.
Ⅱ、Submitting the protocol, consent documents, and Institutional Review Board (IRB) documents to the lead nodeís IRB and making any changes in those documents required by the IRB.
Ⅲ、Distributing the IRB-approved protocol, consent documents, and Institutional Review Board (IRB) documents to participating research sites to assist them in preparing their IRB submissions.
Ⅳ、Preparing and distributing a checklist of items that participating sites must have, and
Ⅴ、Providing regulatory guidance to the study sites as necessary.
1、撰写研究 知情同意书 文件。
2、 将方案、同意文件和机构审查委员会（IRB）文件提交给牵头节点的IRB ，并根据IRB的要求对这些文件进行任何更改。
3、向 参与研究的站点 分发IRB批准的方案、同意文件和机构审查委员会（IRB）文件，以协助它们准备IRB提交的文件。
4、 编制并分发参与现场必须具备的项目清单 ，以及
5、必要时为研究现场提供 监管指导 。
This responsibility continues throughout the duration of the trial e.g. submission of a Protocol Amendment.
该责任在整个试验期间持续，例如提交方案修正案。
Under the supervision of the PI at the site, examples of responsibilities for the Research. Coordinator/Assistant may include:
在现场PI的监督下，提供研究责任的示例。协调员/助理可能包括：
Ⅰ、Ensuring that study data is accurately collected and reported.
Ⅱ、Reporting any study or participant problems.
Ⅲ、Maintaining regulatory files at the study site.
Ⅳ、Working with the Node Quality Assurance Monitor and data management staff to identify and resolve data and reporting issues.
1、 确保准确收集和报告研究数据 。
2、 报告任何研究或参与者问题 。
3、在研究现场 保存监管文件 。
4、与节点质量保证监督员和数据管理人员合作， 识别并解决数据和报告问题 。
The Research Assistant’s role frequently also includes interacting with study participants by performing assessments (e.g., the Addiction Severity Index) and protocol procedures.
研究助理的角色通常还包括通过 评估 （如成瘾严重程度指数） 和协议程序 与研究参与者互动。
Nurses, pharmacists, and other staff are responsible for carrying out study procedures as described in the protocol (e.g., receiving and dispensing medications, conducting physical examinations, delivering behavioral interventions) and for assessing and reporting adverse events to appropriate staff.
护士、药剂师和其他工作人员负责执行方案中所述的研究程序（例如， 接受和分配药物、进行体检、提供行为干预 ），并 负责评估不良事件并向相关工作人员报告 。
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