Contents

Part 2: Responsibilities by Role -- 2

Part 3: Summary of Key Points

Part 2: Responsibilities by Role

Interactive: Study Roles? ?互動：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.

指示用戶閱讀場景，并從提供的多個選項中選擇最佳答案城豁。然后甩鳄，考慮反饋雷滚。

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：中城醫(yī)學研究園的臨床研究團隊面臨著困難的局面。一名參與者在試驗過程中死亡牺弹，研究小組決定提前結束研究湖笨。雖然在這種情況下必須遵循許多表格和協(xié)議，但團隊中誰負責確鄙咏鳎現(xiàn)場的研究參與者獲得研究協(xié)議中概述的適當跟進？

A. Principal Investigator

B. Sub-Investigator

C. Medical Clinician or Physician

D. Interventionist

E. Quality Assurance Monitor

A、首席調查員

B涛救、副調查員

C畏邢、臨床醫(yī)生或內(nèi)科醫(yī)生

D、干預主義者

E检吆、質量保證監(jiān)測

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.

反饋：你選擇了哪一個：A舒萎、B、C蹭沛、D還是E臂寝？研究角色主要負責在研究現(xiàn)場進行臨床研究，個人保留最終責任摊灭，即使特定任務委托給其他人咆贬。如果研究因任何原因提前暫停或停止帚呼，PI負責：及時通知所有研究參與者掏缎；確保所有參與者接受適當?shù)闹委熀碗S訪；并遵守通知監(jiān)管機構的所有要求煤杀。因此眷蜈，正確的回答是A，主要研究者或PI沈自。

Click to view Clinical Trial Network（CTN） related content

More on Roles and Responsibilities for Clinical Trials in the CTN? ?更多關于CTN中臨床試驗的角色和責任

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臨床試驗網(wǎng)絡已經(jīng)建立了應用GCP的流程酌儒，以最大限度地利用其節(jié)點和多中心平臺，并遵守NIH贊助研究的政策枯途。以下定義了CTN中建立的可能不同于其他研究的基礎設施變化和流程今豆。

Medical Expertise (ICH GCP 5.3)? ?醫(yī)學專業(yè)知識

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.

對于CTN研究，首席研究者必須指定一名研究醫(yī)學監(jiān)督員柔袁，負責確保研究參與者的護理和安全。此外异逐，NIDA還任命了一名研究醫(yī)務人員捶索，該醫(yī)務人員具有監(jiān)督作用，并作為首席研究者和研究醫(yī)務監(jiān)督員的資源灰瞻。

Study Design and Management (ICH GCP 5.4, 5.5)? ?研究設計和管理

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.

對于CTN研究腥例，首席研究者必須指定一個方案團隊，負責設計方案酝润、協(xié)助方案實施和準備任何必要的報告燎竖。NIDA通過指定獨立的監(jiān)督委員會來審查所有方案并監(jiān)督研究的進行來履行其職責。如前所述要销，NIDA還聘用了在進行CTN研究的所有研究地點進行質量保證現(xiàn)場考察的監(jiān)督員构回，并要求每個節(jié)點在參與該節(jié)點內(nèi)研究的所有研究地點進行定期現(xiàn)場考察。這些現(xiàn)場考察的結果必須報告給NIDA。

Other Roles and Responsibilities in CTN Studies? ?CTN研究中的其他角色和職責

Everyone working on a study is responsible for:

Ⅰ纤掸、Protecting the rights and safety of study participants,

Ⅱ脐供、Complying with the study protocol, and

Ⅲ、Reporting study data accurately and completely.

從事研究的每個人都有責任：

1借跪、保護研究參與者的權利和安全政己，

2、遵守研究方案掏愁，以及

3歇由、準確、完整地報告研究數(shù)據(jù)果港。

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.

以下描述旨在闡明所有CTN研究中必須履行的角色和責任沦泌，而不是定義個人擔任的具體職位。此處使用的職位名稱可能與參與CTN研究的每個組織使用的職位名稱不同京腥。

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通常被認為是在CTN內(nèi)進行研究的贊助商赦肃。這種考慮在特殊情況下可能有所不同。例如公浪，就FDA而言他宛，如果研究屬于IND，則申辦方為IND持有人欠气；并且厅各，與IND持有人和合作伙伴組織簽訂了責任轉移協(xié)議。雖然發(fā)起人對其開展的任何臨床研究負有主要責任预柒，但CTN將責任全部或部分轉移給合作伙伴組織队塘。

Roles and Responsibilities at Participating Nodes? ?參與節(jié)點的角色和職責

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.

根據(jù)每項研究的授予條款和條件，NIDA將作為發(fā)起人的其他職責轉移給研究的首席研究員和節(jié)點首席研究員宜鸯，如質量保證和控制憔古、監(jiān)督和培訓。

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

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

Ⅱ鸿市、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.

對于CTN研究，NIDA通過以下方式履行質量保證和控制責任：

1即碗、與監(jiān)督員簽訂合同焰情，監(jiān)督員在進行CTN研究的所有研究現(xiàn)場進行質量保證現(xiàn)場考察。

2剥懒、要求每個節(jié)點定期對參與該節(jié)點內(nèi)研究的所有研究站點進行質量保證現(xiàn)場考察内舟。這些現(xiàn)場考察的結果必須報告給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中初橘，網(wǎng)絡基礎設施包括CTN節(jié)點验游，這些節(jié)點對區(qū)域分配的研究站點負有監(jiān)督和培訓責任充岛。每個CTN節(jié)點獨立運作，并根據(jù)其需求和資源創(chuàng)建自己的組織結構批狱。因此裸准，研究人員的職稱和職務說明在節(jié)點之間沒有標準化。在一個節(jié)點上赔硫，多個工作人員可以執(zhí)行一個角色炒俱，而在另一個節(jié)點上，一個工作人員可以執(zhí)行多個角色爪膊。CTN節(jié)點也被指定為區(qū)域性研究地點权悟。以下信息總結了節(jié)點中員工的角色。

Node Principal Investigator? ?節(jié)點/學術帶頭人

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.

節(jié)點PI（或受讓人）負責NIDA在其節(jié)點的研究表現(xiàn)推盛。他或她與節(jié)點工作人員峦阁、研究的首席研究者和研究現(xiàn)場的首席研究者合作實施研究。

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:

節(jié)點項目主管負責確保研究在其節(jié)點順利進行耘成，并在必要時采取適當行動榔昔，協(xié)助主要研究人員和研究站點項目主管及其他研究人員。節(jié)點 PI 的其他職責包括:

Ⅰ瘪菌、Appointing staff to direct study operations.

Ⅱ撒会、Managing the Node budget and staff.

Ⅲ、Appointing a monitor to conduct quality assurance site visits to research sites.

Ⅳ师妙、Ensuring that study staff receives appropriate training to conduct the study.

Ⅴ诵肛、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默穴、任命工作人員指導學習操作怔檩。

2、管理節(jié)點預算和人員蓄诽。

3薛训、任命一名監(jiān)督員對研究站點進行質量保證訪問。

4仑氛、確保研究人員接受適當?shù)呐嘤?/b>進行研究许蓖。

Ⅴ，確保本研究獲得所有必要的IRB批準并遵守所有適用的法規(guī)调衰，以及

Ⅵ，確保他或她在節(jié)點上的機構政策符合這些政策自阱。

Node Coordinator? ?節(jié)點協(xié)調員

The Node Coordinator:

Ⅰ嚎莉、Coordinates all study activities at the Node.

Ⅱ、Ensures that day-to-day activities are conducted in accordance with GCP.

Ⅲ沛豌、Acts as liaison between the Node and the Lead Investigator and the CTN on study matters, and

Ⅳ趋箩、Serves as the main contact for study information at the Node.

1赃额、協(xié)調本節(jié)點的所有學習活動。

2叫确、確保日程迹活動按照GCP進行。

3竹勉、在研究事宜上充當節(jié)點與首席研究員和CTN之間的聯(lián)絡人飞盆，以及

4、作為節(jié)點學習信息的主要聯(lián)系人次乓。

Node Quality Assurance Monitor? ?節(jié)點質量保證監(jiān)測員

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.

節(jié)點QA監(jiān)督員負責監(jiān)測節(jié)點內(nèi)的研究吓歇，并向NIDA、節(jié)點PI和首席研究員報告結果票腰。此人不僅必須非常熟悉研究方案城看，還必須非常熟悉GCP。

Node Regulatory Affairs Staff? ?節(jié)點監(jiān)管事務人員

The Node Regulatory Affairs Staff are responsible for:

節(jié)點法規(guī)事務工作人員負責：

Ⅰ杏慰、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测柠、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缘滥、Submitting data on adverse events, serious adverse events, and protocol violations to the relevant IRBs, according to their requirements.

Ⅴ轰胁、Coordinating continuing IRB review of the study protocol and materials to ensure ongoing IRB approval of the study.

1、向節(jié)點參與站點的機構審查委員會(IRBs)提交研究方案完域、知情同意表和任何其他相關文件软吐。

2、確保研究網(wǎng)站使用最近批準的知情同意文件吟税。

3凹耙、協(xié)助建立和維護該研究的監(jiān)管文件。

4肠仪、根據(jù)相關irb的要求肖抱，提交有關不良事件、嚴重不良事件和協(xié)議違反的數(shù)據(jù)异旧。

5意述、協(xié)調IRB對研究方案和材料的持續(xù)審查，以確保IRB對該研究的持續(xù)批準吮蛹。

Part 3: Summary of Key Points

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

1、《良好臨床實踐（GCP）指南》明確規(guī)定了臨床研究發(fā)起人和主要研究者的責任潮针。

Ⅱ术荤、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、對試驗數(shù)據(jù)的質量和完整性的最終責任始終由主辦方承擔每篷，盡管主辦方的一些義務可能被委托給合作伙伴組織或合同研究組織(CRO)瓣戚。

Ⅲ端圈、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、首席研究員(PI)負責在研究地點進行臨床研究子库，并保留最終責任舱权，即使具體任務被委派給其他現(xiàn)場研究人員。

Click to view Clinical Trial Network（CTN） related content

Ⅰ仑嗅、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宴倍、NIDA臨床試驗網(wǎng)絡（CTN）為其他個人和團體定義了角色和責任，這些個人和團體的工作對于正確開展臨床研究至關重要无畔。

Ⅱ啊楚、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內(nèi)進行的研究的贊助商浑彰。然而恭理，根據(jù)每項研究的授予條款和條件，NIDA將作為贊助商的一些責任轉移給了研究的首席研究員和合同研究組織郭变。

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

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

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

? ?iii周伦、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未荒、根據(jù)研究和CTN結構下涉及的各方：

（1）首席研究員對整個研究負全面責任专挪。

（2）節(jié)點PI（或受讓人）向NIDA負責其節(jié)點的研究績效。

（3）對于節(jié)點參與的每項研究片排，節(jié)點PI為每個研究現(xiàn)場指定一名PI寨腔，負責監(jiān)督現(xiàn)場績效，并負責研究完整性率寡、人類參與者保護以及指定研究現(xiàn)場工作人員履行委托職責迫卢。

（4）每個CTN節(jié)點獨立運作，并根據(jù)其需求和資源創(chuàng)建自己的組織結構冶共。因此乾蛤，職務名稱和職務說明在節(jié)點之間會有所不同。