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

Users are instructed to read the scenario, and choose 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 Research 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 protocols must be followed in this case, 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 choose: A, B, C, D, or E? There is study role primarily responsible for the conduct of a clinical study at a research 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 response 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所有要求。因此，正确的回答是A，主要研究者或PI。

Click to view Clinical Trial Network（CTN） related content

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 processes to apply GCP, to maximize its node and multicenter platform, and that adhere to policies for NIH-sponsored research. The following defines the infrastructure variations and processes established in the CTN that may differ from other research.

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。

Medical Expertise (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 serves as a resource to both the Lead Investigator and the study medical monitor.

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。此外，NIDA还任命了一名研究医务人员，该医务人员具有监督作用，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 research sites where CTN studies are conducted and requires each Node to perform regular site visits at all research sites participating in studies within that Node. Findings from these 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。NIDA通过指定独立的监督委员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。这些现场考察的结果必须报告给NIDA。

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：

1、保护研究参与者的权利和安全，

2、遵守研究方案，以及

3、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 used here may differ from those used at each of the organizations involved in CTN research.

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。此处使用的职位名称可能与参与CTN研究的每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 cases. For example, as far as FDA is concerned, the sponsor is the IND Holder in the case 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。

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.

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、监督和培训。

For CTN studies, NIDA fulfills the Quality Assurance and Control responsibility by:

Ⅰ、Contracting with monitors who perform quality assurance site visits at all research sites where CTN studies are conducted.

Ⅱ、Requiring each Node to perform regular quality assurance site visits at all research sites participating in studies within that Node. Findings from these site visits must be reported to NIDA.

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 research 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 research 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 research 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。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 research 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。

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 research site PIs and other research 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 research 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 these policies.

1、任命工作人员指导学习操作。

2、管理节点预算和人员。

3、任命一名监督员对研究站点进行质量保证访问。

4、确保研究人员接受适当的培训进行研究。

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，以及

Ⅵ，确保他或她在节点上的机构政策符合这些政策。

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.

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。

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，以及

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。此人不仅必须非常熟悉研究方案，还必须非常熟悉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 consent form, and any other relevant documents to the Institutional Review Boards (IRBs) at the Node’s participating sites.

Ⅱ、Ensuring that Research sites use the most recently approved informed consent documents.

Ⅲ、Assisting with the creation and maintenance of regulatory files for the study.

Ⅳ、Submitting data on adverse events, serious adverse 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。

Part 3: Summary of Key Points

Ⅰ、Good Clinical Practice (GCP) guidelines specifically define the responsibilities of the Sponsor and Principal Investigator of a clinical study.

1、《良好临床实践（GCP）指南》明确规定了临床研究发起人和主要研究者的责任。

Ⅱ、The ultimate responsibility for the quality and integrity of the trial data always resides with the Sponsor although some obligations of the sponsor maybe delegated to a partner organization or contract research organization (CRO).

2、对试验数据的质量和完整性的最终责任始终由主办方承担，尽管主办方的一些义务可能被委托给合作伙伴组织或合同研究组织(CRO)。

Ⅲ、The Principal Investigator (PI) is responsible for the conduct of a clinical study at a research site and retains ultimate responsibility even if specific tasks are delegated to other site research staff.

3、首席研究员(PI)负责在研究地点进行临床研究，并保留最终责任，即使具体任务被委派给其他现场研究人员。

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Ⅰ、The NIDA Clinical Trials Network (CTN) has defined roles and responsibilities for other individuals and groups whose work is essential to the proper conduct of a clinical study.

1、NIDA临床试验网络（CTN）为其他个人和团体定义了角色和责任，这些个人和团体的工作对于正确开展临床研究至关重要。

Ⅱ、NIDA is the Sponsor for studies conducted within the CTN. However, under the terms and conditions of the grant award for each study, NIDA transfers some responsibilities as Sponsor to the study’s Lead Investigator and to Contract Research Organizations.

2、NIDA是CTN内进行的研究的赞助商。然而，根据每项研究的授予条款和条件，NIDA将作为赞助商的一些责任转移给了研究的首席研究员和合同研究组织。

Ⅲ、Based on the study and parties involved under the CTN structure:

   i、The Lead Investigator has overall responsibility for the entire study.

   ii、The Node PI (or grantee) is responsible to NIDA for study performance at his or her Node.

   iii、For each study in which the Node is participating, the Node PI designates a PI for each research site, who maintains oversight of site performance and has responsibility for study integrity, human participant protection, and staff performance of delegated responsibilities at the assigned research site(s).

   iv、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 vary across Nodes.

3、根据研究和CTN结构下涉及的各方：

（1）首席研究员对整个研究负全面责任。

（2）节点PI（或受让人）向NIDA负责其节点的研究绩效。

（3）对于节点参与的每项研究，节点PI为每个研究现场指定一名PI，负责监督现场绩效，并负责研究完整性、人类参与者保护以及指定研究现场工作人员履行委托职责。

（4）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，职务名称和职务说明在节点之间会有所不同。