ICH-GCP10.2RolesResponsibilities（2）
Contents
Part 2: Responsibilities by Role -- 2
Part 3: Summary of Key Points
Part 2: Responsibilities by Role
Interactive: Study Roles 互动：研究⾓⾊
Urs are instructed to read the scenario, and choo the best answer from the multiple choices provided. Then, consider the feedback.
指⽰⽤户阅读场景，并从提供的多个选项中选择最佳答案。然后，考虑反馈。
Scenario: The clinical study team at Midtown Medical Rearch Park is facing a difficult situation. A participant has died
during the trial, and the team has decided to end the study prematurely. While many forms and protoco
ls must be followed in this ca, who on the team is responsible for ensuring that the site’s study participants receive appropriate follow-up as outlined in the study protocol?
情景：中城医学研究园的临床研究团队⾯临着困难的局⾯。⼀名参与者在试验过程中死亡，研究⼩组决定提前结束研究。虽然在这种情况下必须遵循许多表格和协议，但团队中谁负责确保现场的研究参与者获得研究协议中概述的适当跟进？
A. Principal Investigator
B. Sub-Investigator
C. Medical Clinician or Physician
D. Interventionist
E. Quality Assurance Monitor
A、⾸席调查员
B、副调查员
C、临床医⽣或内科医⽣
D、⼲预主义者
E、质量保证监测
Feedback: Which did you choo: A, B, C, D, or E? There is study role primarily responsible for the conduct of a clinical study
at a rearch site, and the individual retains ultimate responsibility even if specific tasks are delegated to others. If a study is suspended or stopped early for any reason, the PI is responsible for: promptly informing all study participants; ensuring that all participants receive appropriate therapy and follow-up; and complying with all requirements to inform regulatory authorities. Therefore, the correct respon is A, the Principal Investigator or PI.
反馈：你选择了哪⼀个：A、B、C、D还是E？研究⾓⾊主要负责在研究现场进⾏临床研究，个⼈保留最终责任，即使特定任务委托给其他⼈。如
果研究因任何原因提前暂停或停⽌，PI负责：及时通知所有研究参与者；确保所有参与者接受适当的治疗和随访；并遵守通知监管机构的
PI负责：及时通知所有研究参与者；确保所有参与者接受适当的治疗和随访；并遵守通知监管机构的所有要求。因此，正确的回答是A，主要研究者或PI。
所有要求。
Clinical Trial Network（CTN） related content
Click to view Clinical Trial Network（CTN）
More on Roles and Responsibilities for Clinical Trials in the CTN 更多关于CTN中临床试验的⾓⾊和责任
The NIDA Clinical Trials Network has established process to apply GCP, to maximize its node and multicenter platform, and that adhere to policies for NIH-sponsored rearch. The following defines the infrastructure variations and process established in the CTN that may differ from other rearch.
CTN中建⽴NIDA临床试验⽹络已经建⽴了应⽤GCP的流程，以最⼤限度地利⽤其节点和多中⼼平台，并遵守NIH赞助研究的政策。以下定义了CTN中建⽴的可能不同于其他研究的基础设施变化和流程。
的可能不同于其他研究的基础设施变化和流程
Medical Experti (ICH GCP 5.3) 医学专业知识
For CTN studies, the Lead Investigator must designate a study medical monitor, who is responsible for ensuring the care and safety of study participants. In addition, NIDA appoints a study medical officer, who has an oversight role and rves as a resource to both the Lead Investigator and the study medical monitor.
⾸席研究者必须指定⼀名研究医学监督员，负责确保研究参与者的护理和安全。此外，NIDA还任命了⼀名研究医务⼈员
研究医务⼈员，对于CTN研究，⾸席研究者必须指定⼀名研究医学监督员，负责确保研究参与者的护理和安全
并作为⾸席研究者和研究医务监督员的资源。
该医务⼈员具有监督
监督作⽤，并作为⾸席研究者和研究医务监督员的资源
Study Design and Management (ICH GCP 5.4, 5.5) 研究设计和管理
For CTN studies, the Lead Investigator must designate a protocol team that designs the protocol, assists in protocol implementation and prepares any necessary reports. NIDA fulfills its responsibilities by designating independent oversight boards to review all protocols and monitor the conduct of the studies. As noted earlier, NIDA also contracts monitors who perform quality assurance site visits at all rearch sites where CTN studies are conducted and requires each Node to
perform regular site visits at all rearch sites participating in studies within that Node. Findings from the site visits must be reported to NIDA.
对于CTN研究，⾸席研究者必须指定⼀个⽅案团队，负责设计⽅案、协助⽅案实施和准备任何必要的报告
⾸席研究者必须指定⼀个⽅案团队，负责设计⽅案、协助⽅案实施和准备任何必要的报告。NIDA通过指定独⽴的监督委员
在进⾏CTN研究的所有研究地点进⾏质量保证现场考察的监督会来审查所有⽅案并监督研究的进⾏来履⾏其职责。如前所述，NIDA还聘⽤了在进⾏CTN研究的所有研究地点进⾏质量保证现场考察的监督
并要求每个节点在参与该节点内研究的所有研究地点进⾏定期现场考察。这些现场考察的结果必须报告给NIDA。
员，并要求每个节点在参与该节点内研究的所有研究地点进⾏定期现场考察
Other Roles and Responsibilities in CTN Studies CTN研究中的其他⾓⾊和职责
Everyone working on a study is responsible for:
Ⅰ、Protecting the rights and safety of study participants,
Ⅱ、Complying with the study protocol, and
Ⅲ、Reporting study data accurately and completely.
从事研究的每个⼈都有责任：
保护研究参与者的权利和安全，
1、保护研究参与者的权利和安全
遵守研究⽅案，以及
2、遵守研究⽅案
3、准确、完整地报告研究数据
准确、完整地报告研究数据。
The following descriptions are intended to clarify roles and responsibilities that must be fulfilled in all CTN studies, not to define specific positions held by individuals. The position titles ud here may differ from tho ud at each of the organizations involved in CTN rearch.
阐明所有CTN研究中必须履⾏的⾓⾊和责任，⽽不是定义个⼈担任的具体职位。此处使⽤的职位名称可能与参与CTN研究的每以下描述旨在阐明所有CTN研究中必须履⾏的⾓⾊和责任，⽽不是定义个⼈担任的具体职位
个组织使⽤的职位名称不同。
NIDA is typically considered to be the Sponsor for studies conducted within the CTN. This consideration may vary in special cas. For example, as far as FDA is concerned, the sponsor is the IND Holder in the ca that the study is under IND; and, an agreement for transferring responsibilities is documented with the IND Holder and the partner organization. While the Sponsor
maintains primary responsibility for any clinical investigations it conducts, the CTN transfers responsibilities wholly or partially to a partner organization.
NIDA通常被认为是在CTN内进⾏研究的赞助商。这种考虑在特殊情况下可能有所不同。例如，就FDA⽽⾔，如果研究属于IND，则申办⽅为IND
虽然发起⼈对其开展的任何临床研究负有主要责任，但CTN将责任全部持有⼈；并且，与IND持有⼈和合作伙伴组织签订了责任转移协议。虽然发起⼈对其开展的任何临床研究负有主要责任，但CTN将责任全部或部分转移给合作伙伴组织。
或部分转移给合作伙伴组织
Roles and Responsibilities at Participating Nodes 参与节点的⾓⾊和职责
Under the terms and conditions of the grant award for each study, NIDA transfers other responsibilities as Sponsor to the study’s Lead Investigator and the Node Principal Investigator, such as Quality Assurance and Control, oversight, and training.
监督和培
质量保证和控制、监督和培
根据每项研究的授予条款和条件，NIDA将作为发起⼈的其他职责转移给研究的⾸席研究员和节点⾸席研究员，如质量保证和控制
训。
For CTN studies, NIDA fulfills the Quality Assurance and Control responsibility by:
Ⅰ、Contracting with monitors who perform quality assurance site visits at all rearch sites where CTN studies are conducted.
Ⅱ、Requiring each Node to perform regular quality assurance site visits at all rearch sites participating in studies within that Node. Findings from the site visits must be reported to NIDA.
质量保证和控制责任：
对于CTN研究，NIDA通过以下⽅式履⾏质量保证和控制责任
1、与监督员签订合同，监督员在进⾏CTN研究的所有研究现场进⾏质量保证现场考察。
2、要求每个节点定期对参与该节点内研究的所有研究站点进⾏质量保证现场考察。这些现场考察的结果必须报告给NIDA。
In the CTN, the network infrastructure includes CTN Nodes that have oversight and training responsibilities for regionally assigned rearch sites. Each CTN Node functions independently and creates its own organizational structure, depending on its needs and resources. As a result, job titles and job descriptions for rearch staff are not standardized across Nodes. At
one Node, multiple staff members may perform one role, whereas at another Node, one staff member may perform multiple roles. The CTN Nodes are also assigned rearch sites regionally. The following information summarizes the roles of staff at the Node.
在CTN中，⽹络基础设施包括CTN节点，这些节点对区域分配的研究站点负有监督和培训责任。每个CTN节点独⽴运作，并根据其需求和资源创建⾃⼰的组织结构。因此，研究⼈员的职称和职务说明在节点之间没有标准化
研究⼈员的职称和职务说明在节点之间没有标准化。在⼀个节点上，多个⼯作⼈员可以执⾏⼀个⾓⾊，⽽在另⼀个节点上，⼀个⼯作⼈员可以执⾏多个⾓⾊。CTN节点也被指定为区域性研究地点。以下信息总结了节点中员⼯的⾓⾊。
Node Principal Investigator 节点/学术带头⼈
The Node PI (or grantee) is responsible to NIDA for study performance at his or her Node. He or she works with Node staff, the study’s Lead Investigator, and the Principal Investigator at the rearch sites to implement the study.
节点PI（或受让⼈）负责NIDA在其节点的研究表现。他或她与节点⼯作⼈员、研究的⾸席研究者和研究现场的⾸席研究者合作实施研究。
节点PI（或受让⼈）负责NIDA在其节点的研究表现
The Node PI is responsible for ensuring that the study runs smoothly at his or her Node and for taking appropriate action when necessary to assist the Lead Investigator and rearch site PIs and other rearch staff. Other responsibilities of the Node PI include:
节点项⽬主管负责确保研究在其节点顺利进⾏，并在必要时采取适当⾏动，协助主要研究⼈员和研究站点项⽬主管及其他研究⼈员。节点 PI 的其他职责包括:
Ⅰ、Appointing staff to direct study operations.
Ⅱ、Managing the Node budget and staff.
Ⅲ、Appointing a monitor to conduct quality assurance site visits to rearch sites.
Ⅳ、Ensuring that study staff receives appropriate training to conduct the study.
Ⅴ、Ensuring that the study receives all necessary IRB approvals and follows all applicable regulations, and
Ⅵ、Ensuring compliance of his or her institutional policies at the Node with the policies.
1、任命⼯作⼈员指导学习操作
指导学习操作。
预算和⼈员。
2、管理节点预算和⼈员
质量保证访问。
3、任命⼀名监督员对研究站点进⾏质量保证访问
适当的培训进⾏研究。
4、确保研究⼈员接受适当的培训
IRB批准并遵守所有适⽤的法规，以及
Ⅴ，确保本研究获得所有必要的IRB批准并遵守所有适⽤的法规
机构政策符合这些政策。
Ⅵ，确保他或她在节点上的机构政策
Node Coordinator 节点协调员
The Node Coordinator:
Ⅰ、Coordinates all study activities at the Node.
Ⅱ、Ensures that day-to-day activities are conducted in accordance with GCP.
Ⅲ、Acts as liaison between the Node and the Lead Investigator and the CTN on study matters, and
Ⅳ、Serves as the main contact for study information at the Node.
协调本节点的所有学习活动。
1、协调本节点的所有学习活动
2、确保⽇常活动按照GCP进⾏
确保⽇常活动按照GCP进⾏。
联络⼈，以及
3、在研究事宜上充当节点与⾸席研究员和CTN之间的联络⼈
主要联系⼈。
4、作为节点学习信息的主要联系⼈
Node Quality Assurance Monitor 节点质量保证监测员
The Node QA Monitor is responsible for monitoring the study within the Node and reporting findings to NIDA, the Node PI, and the Lead Investigator. This individual must be intimately familiar not only with the study protocol but also with GCP.
节点QA监督员负责监测节点内的研究，并向NIDA、节点PI和⾸席研究员报告结果
并向NIDA、节点PI和⾸席研究员报告结果。此⼈不仅必须⾮常熟悉研究⽅案，还必须⾮常熟悉
节点QA监督员负责监测节点内的研究
GCP。
Node Regulatory Affairs Staff 节点监管事务⼈员
The Node Regulatory Affairs Staff are responsible for:
节点法规事务⼯作⼈员负责：
Ⅰ、Submitting the study protocol, informed connt form, and any other relevant documents to the Institutional Review Boards (IRBs) at the Node’s participating sites.
Ⅱ、Ensuring that Rearch sites u the most recently approved informed connt documents.
Ⅲ、Assisting with the creation and maintenance of regulatory files for the study.
Ⅳ、Submitting data on adver events, rious adver events, and protocol violations to the relevant IRBs, according to their requirements.
Ⅴ、Coordinating continuing IRB review of the study protocol and materials to ensure ongoing IRB approval of the study.
1、向节点参与站点的机构审查委员会(IRBs)提交研究⽅案、知情同意表和任何其他相关⽂件。
2、确保研究⽹站使⽤最近批准的知情同意⽂件。
3、协助建⽴和维护该研究的监管⽂件。
4、根据相关irb的要求，提交有关不良事件、严重不良事件和协议违反的数据。
5、协调IRB对研究⽅案和材料的持续审查，以确保IRB对该研究的持续批准。
