ICH-GCP10.1RolesResponsibilities（1）
Contents
Part 1: Introduction
Part 2: Responsibilities by Role -- 1
Part 3: Summary of Key Points
Part 1: Introduction
Many individuals and groups are involved in conducting a clinical study. The central roles are tho of the Sponsor and Principal Investigator, as defined by Good Clinical Practice (GCP) guidelines.
主要研究者。
发起⼈和主要研究者
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
There are additional roles and responsibilities defined for other individuals and groups who work is esntial to the proper conduct of a clinical study. How the roles are referenced, may vary from one rearch network to another.
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另外还为其他个⼈和团体规定了额外的⾓⾊和责任
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 the 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。
Part 2: Responsibilities by Role
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、Rearch 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
中⼼⾓⾊：
Sponsor 发起⼈
MONITORING 监测
Da ta a nd Sa fety Mo nito r ing 数据和安全监测
ring 数据和安全监测
All NIH–supported multicenter Pha 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.
药物治疗研究，也适⽤于⾏为研
⾏为研
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
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
究。
Members of each DSMB include experts in the dia area, treatment, clinical trial design, biostatistics, and rearch ethics. The DSMBs are appointed by and report to the sponsor. Their role is to:
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
作⽤是：
Ⅰ、Protect participant safety by being familiar with the study, proposing appropriate analys, 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, loss to follow-up, and other measures of adherence to the study protocol.
Ⅳ、Monitor adver 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
rearch studies.
审查结果和安全数据
安全数据来保护参与者的安全。
提出适当的分析，并审查结果
熟悉研究，提出适当的分析
1、通过熟悉研究
其他遵守研究⽅案的措施等问题的数据，确保研究的完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
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
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
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 e 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。
QA & QC 质量保证和质量控制
Qua lity Assur a nc e a nd Qua lity Co ntro l (ICH GCP 5.1)
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.
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。
申办⽅负责实施和维护质量保证和质量控制系统
EXPERTISE 专业知识
Medic a l Exper ti (ICH GCP 5.3)
The Sponsor is responsible for designating appropriately qualified medical personnel to advi 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。
STUDY DESIGN & MANAGEMENT 研究设计与管理
Study Design a nd Ma na gem ent (ICH GCP 5.4, 5.5))
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 analys.
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。
TRANSFER OF OBLIGATIONS 转让的义务
Tr a nsfer o f Tr ia l-R ela ted Obliga tio ns 与审判有关的义务的转移
The Sponsor may transfer any or all of the Sponsor’s trial-related duties and functions to a Contract
Rearch 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
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。
Principal Investigator ⾸席研究员
OVERVIEW 概述
Over view
Overview
While studies have a Lead Investigator with primary responsibility over the entire trial, this individual is often the Principal Investigator (PI) at the lead rearch site and has responsibility over the conduct of a clinical study at that site. For multicenter trials, there are a number of rearch sites, each with its own Principal Investigator with oversight responsibility and staff involved in the conduct of a study.
并负责在该地点进⾏临床研究。
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虽然研究中有⼀名主要研究者对整个试验负主要责任
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）
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 rearch staff. Additionally, PI responsibilities include:
其他现场研究⼈员，PI仍保留最终监督责任
PI仍保留最终监督责任。此外，PI的职责包括：
即使将特定任务委托给其他现场研究⼈员
Ⅰ、Documenting the delegation of study responsibilities to qualified and adequately trained rearch staff.
Ⅱ、Supervising study performance and overeing the performance of study staff at the rearch sites.
Ⅲ、Ensuring that:
i、Participants’ well-being and safety are protected.
ii、All study procedures are conducted at the rearch sites in accordance with the protocol and GCP.
Ⅳ、Preparing a communication plan for all staff involved in the study.
Ⅴ、Overeing Investigational product accountability.
研究责任委托给合格且经过充分培训的研究⼈员。
1、将研究责任委托
监督研究绩效，监督研究现场研究⼈员的绩效。
2、监督研究绩效
3、确保：
参与者的福利和安全受到保护。
（1）参与者的福利和安全受到保护
所有研究程序均按照⽅案和GCP在研究现场进⾏。
（2）所有研究程序均按照⽅案和GCP在研究现场进
沟通计划。
4、为参与研究的所有员⼯制定沟通计划
监督试验产品的责任。
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 & EXPERIENCE 资格和经验
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 u of an investigational product, be thoroughly familiar with the appropriate u 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：
教育、培训和经验，有资格承担正确开展研究的责任。
1、通过教育、培训和经验
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。
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。
4、保存⼀份合格⼈员名单
CARE FOR PARTICIPANTS 对参与者的关怀
Medic a l Ca r e o f Study Pa rtic ipa nts (ICH GCP 4.3)
All study participants should receive appropriate medical care both for study-related adver 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.
医疗决策负责。
1、参与研究的合格医师应对所有与研究相关的医疗决策
初级保健医⽣，前提是参与者：
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
（1）有⼀位初级保健医⽣。
（2）同意可以通知初级保健医⽣。
