Part 3: Overview of main points

Guide the user to read the scenario and choose the best answer from the multiple options provided. Then consider the feedback.

Guide the user to read the scenario and choose the best answer from the multiple options provided. Then consider the feedback.

Situation: The clinical research team in Midtown Medical Research Park is facing a difficult situation. One participant died during the experiment, and the research team decided to end the study early. Although many forms and protocols must be followed in this case, who in the team is responsible for ensuring that the research participants in the research center receive appropriate follow-up outlined in the research protocol?

Situation: The clinical research team in Midtown Medical Research Park is facing a difficult situation. One participant died during the experiment, and the research team decided to end the study early. Although many forms and protocols must be followed in this case, who in the team is responsible for ensuring that the research participants in this field are properly followed up as outlined in the research protocol?

A. Principal investigator

B. Deputy investigator

C. internal medicine clinician or physician

D. interventionist

E. Quality assurance monitoring

I. Chief Investigator

B. Deputy investigator

C, clinicians or physicians

D, interventionist

E, quality assurance monitoring

Feedback: Which one did you choose: A, B, C, D or E? There is a research role that is mainly responsible for conducting clinical research in the research center. Even if the specific task is entrusted to others, the individual still retains the ultimate responsibility. If the study is suspended or stopped prematurely for any reason, PI is responsible for: immediately notifying all participants of the study; Ensure that all participants receive appropriate treatment and follow-up treatment; And comply with all requirements for notifying the regulatory authorities. Therefore, the correct answer is A, the principal investigator or PI.

Feedback: Which one did you choose: A, B, C, D or E? The research role is mainly responsible for conducting clinical research at the research site, and the individual retains the ultimate responsibility, even if the specific tasks are entrusted to others. If the research is suspended or stopped in advance for any reason, PI is responsible for: notifying all research participants in time; Ensure that all participants receive appropriate treatment and follow-up treatment; And comply with all requirements for notifying the regulatory authorities. Therefore, the correct answer is A, the principal investigator or PI.

Click to view the related contents of Clinical Trial Network (CTN).

NIDA clinical trial network has established the process of applying GCP to maximize its nodes and multi-center platform, and abide by the NIH policy of sponsoring research. The following defines the infrastructure changes and processes established in CTN that may be different from other studies.

The NIDA clinical trial network has established the process of applying for GCP, so as to make full use of its nodes and multi-center platform and abide by the NIH policy of sponsoring research. The following defines the infrastructure changes and processes established in CTN, which may be different from other studies.

For CTN research, the lead researcher must appoint a research medical supervisor who is responsible for ensuring the care and safety of research participants. In addition, NIDA appoints a research medical officer, who has a supervisory role and serves as a resource for the chief researcher and research medical supervisor.

For CTN research, the lead researcher must appoint a research medical supervisor who is responsible for ensuring the care and safety of research participants. In addition, NIDA has appointed a research medical staff, who has a supervisory role and serves as a resource for the chief researcher and the research medical director.

For CTN research, the lead researcher must appoint a scheme team to design the scheme, assist in its implementation and prepare any necessary reports. NIDA performs its duties by appointing an independent supervisory committee to review all agreements and supervise the research. As mentioned above, NIDA also signed a contract with the supervisor, who conducted quality assurance on-site visits at all research sites where CTN research was conducted, and required each node to conduct regular on-site visits at all research sites in the node. The results of these field visits must be reported to NIDA.

For CTN research, the lead researcher must designate a project team to design the project, assist its implementation and prepare any necessary reports. NIDA fulfilled its responsibilities by appointing an independent supervisory committee to review all projects and supervise research. As mentioned above, NIDA also hired supervisors to conduct quality assurance on-site inspections on all research sites where CTN research was conducted, and required each node to conduct regular on-site inspections on all research sites participating in the research within the node. The results of these field trips must be reported to NIDA.

Everyone involved in the study has the responsibility to:

First, protect the rights and safety of the subjects.

Ii. Abide by the research plan, and

Iii. report the research data accurately and completely.

Everyone involved in the study has the responsibility to:

1, protect the rights and interests and safety of research participants,

2. Abide by the research plan, and

3. Report the research data accurately and completely.

The following description aims at clarifying the roles and responsibilities that must be performed in all CTN research, rather than defining the specific positions of individuals. The job title used here may be different from that used by each organization participating in the CTN study.

The following description aims at clarifying the roles and responsibilities that must be performed in all CTN research, rather than defining the specific positions held by individuals. The job name used here may be different from the name used by each organization participating in the CTN study.

NIDA is usually considered as a sponsor of research conducted in CTN. Under special circumstances, this consideration may be different. For example, as far as FDA is concerned, if the research is controlled by IND, the sponsor is the holder of IND; In addition, responsibility transfer agreements have been signed with IND holders and partner organizations. Although the sponsor bears the main responsibility for any clinical research it conducts, CTN transfers all or part of the responsibility to the cooperative organization.

NIDA is usually considered as a sponsor of CTN research. This consideration may be different under special circumstances. For example, as far as FDA is concerned, if the research belongs to IND, then the applicant is the holder of IND; In addition, we have signed responsibility transfer agreements with IND holders and partner organizations. Although the sponsors have the main responsibility for any clinical research they carry out, CTN will transfer all or part of the responsibility to the cooperative organization.

According to the funding terms and conditions of each study, NIDA will transfer other responsibilities as the organizer to the chief researcher of the study and the chief researcher of the node, such as quality assurance and control, supervision and training.

According to the awarding terms and conditions of each study, NIDA will hand over other responsibilities as the organizer to the chief researcher of the study and the chief researcher of the node, such as quality assurance and control, supervision and training.

For CTN research, NIDA fulfills its responsibility for quality assurance and control in the following ways:

I. Sign a contract with the supervisor, and the supervisor will conduct quality assurance on-site visits at all research sites where CTN research is conducted.

Ii. Each node is required to conduct regular quality assurance site visits to all research points participating in the research within the node. The results of these field visits must be reported to NIDA.

For CTN research, NIDA fulfills its responsibility of quality assurance and control in the following ways:

1. Sign a contract with the supervisor, who will conduct quality assurance on-site inspection at all research sites where CTN research is conducted.

2. Each node is required to conduct regular quality assurance on-site visits to all research points participating in the research within the node. The results of these field trips must be reported to NIDA.

In CTN, the network infrastructure includes CTN nodes, which are responsible for supervising and training the research sites designated by the region. Each CTN node operates independently and creates its own organizational structure according to its needs and resources. Therefore, the titles and job descriptions of researchers are not standardized among nodes. On one node, multiple staff members can perform one role, while on another node, one staff member can perform multiple roles. CTN nodes also allocated research sites by region. The following information summarizes the roles of employees in the node.

In CTN, the network infrastructure includes CTN nodes, which are responsible for supervising and training the research sites distributed in this area. Each CTN node runs independently and creates its own organizational structure according to its needs and resources. Therefore, the titles and job descriptions of researchers are not standardized among nodes. On one node, multiple employees can play one role, while on another node, one employee can play multiple roles. CTN nodes are also designated as regional research points. The following information summarizes the roles of employees in the node.

Node PI (or grantee) is responsible for the research performance of its nodes to NIDA. He or she cooperates with the node staff, the lead researcher of the research and the lead researcher of the research site to carry out the research.

Node PI (or assignee) is responsible for the research performance of NIDA at its node. He or she cooperates with the node personnel, the chief researcher of the research and the chief researcher of the research site to carry out the research.

Node PI is responsible for ensuring the smooth progress of research at his or her node, and taking appropriate measures to assist the chief researcher, research point PI and other researchers when necessary. Other responsibilities of the node PI include:

The project leader of the node is responsible for ensuring the smooth progress of the research in its node and taking appropriate actions to assist the main researchers, the project leader of the research site and other researchers when necessary. Other responsibilities of the node PI include:

First, assign personnel to guide the research work.

Second, manage the node budget and personnel.

Appoint a supervisor to conduct a quality assurance on-site inspection of the research site.

Ⅳ. Ensure that researchers receive appropriate training to carry out research.

ⅴ. Ensure that the research obtains all necessary IRB approvals and complies with all applicable regulations, and

ⅵ. Ensure the compliance of the policies of this node.

1. Assign staff to guide the learning operation.

2. Manage the budget and personnel of the node.

3. Appoint a supervisor to visit the research site to ensure the quality.

4. Ensure that researchers receive appropriate research training.

ⅴ. Ensure that this research is approved by all necessary IRB and complies with all applicable laws and regulations, and

ⅵ. Ensure that his or her institutional policies on the node conform to these policies.

Node coordinator:

I. Coordinate all learning activities of nodes.

Ensure that daily activities are carried out in accordance with GCP.

Iii. Liaise with the main researchers and CTN on research matters, and

Ⅳ. Be the main contact person for learning information of this node.

1. Coordinate all learning activities of this node.

2. Ensure that daily activities are carried out according to GCP requirements.

3. Acting as the liaison between the node and the chief researcher and CTN, and

4. As the main contact person for learning node information.

The node QA supervisor is responsible for monitoring the research within the node and reporting the research results to NIDA, node PI and chief researcher. This person must be very familiar not only with the research scheme, but also with GCP.

The QA supervisor of the node is responsible for monitoring the research within the node and reporting the results to NIDA, node PI and the chief researcher. This person must be very familiar not only with the research plan, but also with GCP.

Node supervision affairs personnel are responsible for:

Node legal affairs personnel are responsible for:

I. Submit the research proposal, informed consent and any other relevant documents to the IRB of the node participating location.

Ii. ensure that the research center uses the latest approved informed consent document.

Iii. Assist in establishing and maintaining the research laws and regulations files.

Ⅳ. Submit the data of adverse events, serious adverse events and violations to the relevant IRB as required.

ⅴ. Coordinate IRB's continuous review of research plans and materials to ensure IRB's continuous approval of research.

1. Submit the research proposal, informed consent and any other relevant documents to the IRB of the node participating site.

2. Ensure that the research website uses the recently approved informed consent form.

3. Assist in establishing and maintaining regulatory documents for research.

4. Submit the data of adverse events, serious adverse events and protocol violations according to the requirements of relevant irb.

5. Coordinate IRB's continuous review of research plans and materials to ensure IRB's continuous approval of research.

1. Good Clinical Practice (GCP) Guidelines clearly stipulate the responsibilities of the sponsor and the principal investigator of clinical research.

1, "Good Clinical Practice (GCP) Guide" clearly stipulates the responsibilities of clinical research sponsors and main researchers.

Ii. Although some obligations of the organizer can be entrusted to cooperative institutions or contract research institutions (CRO), the ultimate responsibility for the quality and integrity of test data always lies with the organizer.

2. The ultimate responsibility for testing the quality and integrity of data is always borne by the organizer, although some obligations of the organizer may be entrusted to cooperative organizations or contract research organizations (CRO).

Iii. The Principal Investigator (PI) is responsible for conducting clinical research in the research center, and retains the ultimate responsibility, even if the specific tasks are entrusted to the staff of other research centers.

3. The Principal Investigator (PI) is responsible for conducting clinical research at the research site, and retains the ultimate responsibility, even if the specific tasks are entrusted to researchers in other fields.

Click to view the related contents of Clinical Trial Network (CTN).

I. NIDA Clinical Trial Network (CTN) has stipulated roles and responsibilities for other individuals and groups, and their work is essential for the correct conduct of clinical research.

1, NIDA clinical trial network (CTN) defines roles and responsibilities for other individuals and groups, and their work is very important for the correct development of clinical research.

NIDA is a sponsor of the research conducted in CTN. However, according to the funding terms and conditions of each research, NIDA transfers some responsibilities as a sponsor to the main researchers and contract research organizations.

2.NIDA is a sponsor of the research conducted in CTN. However, according to the awarding terms and conditions of each study, NIDA transferred some responsibilities as a sponsor to the chief researcher and contract research organization of the study.

Third, research and related parties based on the framework of CTN:

I. The chief researcher is fully responsible for the whole research.

Ii. Node PI (or grantee) is responsible for the research performance of its nodes to NIDA.

Iii. For each research in which the node participates, the node PI designates a PI for each research point, which is responsible for supervising the performance of the research point, and is responsible for the research integrity, the protection of human participants and the employee performance of the assigned research point.

Fourth, each CTN node operates independently and establishes its own organizational structure according to its needs and resources. Therefore, the titles and job descriptions of different nodes will be different.

3. According to the research and the parties involved under the CTN structure:

(1) The lead researcher is fully responsible for the whole study.

(2) Node PI (or transferee) is responsible for the research performance of its nodes to NIDA.

(3) For each research that the node participates in, the node PI designates a PI for each research site, which is responsible for supervising the performance of the site, protecting the integrity of the research and human participants, and designating the staff of the research site to perform the entrusted duties.

(4) Each CTN node runs independently and creates its own organizational structure according to its needs and resources. Therefore, the job name and job description will be different between nodes.