Part 2: Responsibilities by Role-1

Part 3: Overview of main points

Many individuals and groups participate in clinical research. According to the definition of good clinical practice (GCP) guidelines, the main roles are organizers and main researchers.

Many individuals and groups participated in clinical research. According to the definition of good clinical practice (GCP) guidelines, the central role is the initiator and the main researcher.

For other individuals and groups whose work is crucial to the correct conduct of clinical research, additional roles and responsibilities are also stipulated. How to cite these roles may be different for different research networks.

In addition, it also provides additional roles and responsibilities for other individuals and groups, and their work is very important for the correct conduct of clinical research. The references of these roles may be different in different research networks.

This module will:

Discuss the roles and responsibilities of the sponsors and main researchers outlined in the GCP guidelines.

Briefly describe how these roles and responsibilities are performed in clinical research.

Discuss the roles and responsibilities of other individuals and groups involved in the study.

This module will:

1. Discuss the roles and responsibilities of the sponsors and main researchers outlined in the GCP guidelines.

2. Briefly describe how these roles and responsibilities are performed in clinical research.

3. Discuss the roles and responsibilities of other individuals and groups participating in the research.

The following is a summary of the responsibilities outlined in the GCP guidelines based on roles.

The following is a summary of the responsibilities listed by role in the GCP Guide.

Core role:? Sponsor, main researcher, other roles, research center staff

Core roles: sponsor, main researcher, other roles, research site staff.

All multi-center phase III clinical trials supported by NIH must have an independent Data and Safety Monitoring Committee (DSMB). This requirement applies to drug therapy research and behavior research.

All multi-center phase III clinical trials supported by NIH must have an independent Data and Safety Monitoring Committee (DSMB). This requirement applies to drug therapy research and behavior research.

The members of each DSMB include experts in the field of diseases, treatment, clinical trial design, biostatistics and research ethics. DSMBs is appointed by the organizer and reports to the organizer. Their roles are:

Members of each DSMB include experts in the fields of disease, treatment, clinical trial design, biostatistics and research ethics. DSMB is appointed by the sponsor and reports to the sponsor. Their roles are:

I. Protect participants' safety by familiarizing themselves with the research, putting forward appropriate analysis and reviewing available results and safety data.

Ii. To ensure the integrity of the study by reviewing the data on the registration of participants, on-site visits, research procedures, form filling, data quality, loss of follow-up and other measures to comply with the research plan.

Ⅳ. Monitor adverse events, and suggest changing the research scheme or operation when necessary. This monitoring function is traditionally provided by IRB, which is especially important for multi-center research.

1, through familiar research, put forward appropriate analysis, and review the results and safety data to protect the safety of participants.

2. The integrity of the study was ensured by reviewing the data of the subjects' registration, field visits, research procedures, form filling, data quality, follow-up loss and other measures in line with the research plan.

3. Monitor adverse events, and suggest to modify the research plan or operation when necessary. This monitoring function goes beyond the traditional supervision provided by IRB, and is especially important for multi-center research.

Click here to view the NIH policy document on data and security monitoring.

Click here to view NIH's policy document on data and security monitoring.

The organizer is responsible for implementing and maintaining the quality assurance and quality control system to ensure that the research is carried out and recorded in accordance with the scheme, GCP and regulatory requirements.

The organizer is responsible for implementing and maintaining the quality assurance and quality control system to ensure that the research is conducted and recorded in accordance with the scheme, GCP and regulatory requirements.

The organizer is responsible for appointing appropriate qualified medical personnel to make suggestions on medical problems related to the experiment.

The organizer is responsible for appointing suitable qualified medical personnel and providing advice on medical problems related to the trial.

The sponsor is responsible for appointing qualified personnel to carry out all stages of the research process, including:

The sponsor is responsible for appointing qualified personnel to carry out all stages of the research process, including:

I. Protocol design.

Ii. supervise the whole research.

Ⅲ. Management and verification of research data.

Ⅳ. Ensure the safety and rights of human participants.

ⅴ. Monitor academic performance.

ⅵ. Statistical analysis of planning and implementation.

ⅶ. Prepare the research report.

1, protocol design.

2. Supervise the overall development of research.

3. Manage and validate research data.

4. Ensure the safety and rights of human rights participants.

5. Monitor academic performance.

6. Planning and statistical analysis.

7. Write a research report.

The sponsor may transfer any or all of the responsibilities and functions related to the test to the Contract Research Institute (CRO). However, the organizer always bears the ultimate responsibility for the quality and completeness of the test data. Any test-related responsibilities and functions handed over to CRO shall be specified in writing.

The sponsor may transfer any or all of its responsibilities and functions related to testing to the Contract Research Institute (CRO). However, the organizer always bears the ultimate responsibility for the quality and integrity of the test data. Any trial-related duties and functions transferred to the chief prosecutor and assumed by the chief prosecutor are clearly defined in writing.

Although the study has a principal investigator who is mainly responsible for the whole trial, this person is usually the principal investigator (PI) of the principal research center, who is responsible for conducting clinical research in the center. For multi-center experiments, there are many research centers, and each center has its own main researcher in charge of supervision and staff involved in the research.

Although there is a principal investigator in the study who is mainly responsible for the whole trial, this person is usually the principal investigator (PI) in the main research site and is responsible for conducting clinical research in that site. For multi-center experiments, there are many research sites, and each research site has its own main researcher and staff involved in the research.

Even if a specific task is delegated to other field researchers, PI still retains the ultimate supervisory responsibility. In addition, the responsibilities of PI include:

Even if a specific task is entrusted to researchers in other fields, PI still retains the ultimate supervisory responsibility. In addition, the responsibilities of PI include:

I. Record the delegation of research responsibility to qualified and fully trained researchers.

Ii. supervise the research performance and supervise the performance of researchers in the research center.

Third, ensure that:

1. Protect the health and safety of participants.

Ii. All research procedures are carried out in the research center according to the research plan and GCP.

Ⅳ. Prepare a communication plan for all employees involved in the study.

ⅴ. Responsibility for supervising and researching products.

1. Entrust the research responsibility to qualified and trained researchers.

2. Supervise the research performance and the performance of field researchers.

3. Ensure that:

(1) The welfare and safety of the participants are guaranteed.

(2) All research procedures were carried out in the research site according to the scheme and GCP.

4. Make a communication plan for all employees involved in the study.

5. Responsibility for supervising and inspecting products.

It is worth noting that PI must sign the agreement signature page in this capacity. If the research is conducted under the application for new drug research (IND), PI must also sign the FDA 1572 form.

Please note that PI must sign the agreement signature page. If the research is conducted under the new drug research application (IND), PI must also sign the FDA 1572 form.

Qualifications and experience (ICH GCP 4. 1)

PI must:

I. It has been proved through education, training and experience that it is qualified to undertake the responsibility of properly carrying out research.

Ii. If the study involves the use of the study drug, please be fully familiar with the appropriate use of the drug described in the study plan.

Iii. Understand and abide by GCP and applicable regulatory requirements.

Ⅳ. Keep a list of qualified personnel to whom he or she entrusts important research-related responsibilities.

PI must:

1, through education, training and experience, qualified to undertake the responsibility of conducting research correctly.

2. If the research involves the use of experimental products, you should be fully familiar with the correct use of the products described in the research plan.

3. Understand and abide by GCP and applicable regulatory requirements.

4. Keep a list of qualified personnel to whom he or she will entrust important learning-related responsibilities.

All participants in the study should receive appropriate medical care, including adverse events related to the study and all diseases unrelated to the study.

All participants in this study should receive appropriate medical care for adverse events related to this study and all medical conditions unrelated to this study.

ⅰ. Qualified doctors related to research should be responsible for all medical decisions related to research.

Ii. The attending physician of the participant shall be informed of the participant's participation in the study, provided that the participant:

I have a primary care doctor.

Ii. Agree to inform the primary care doctor.

1. Qualified doctors participating in the study should be responsible for all medical decisions related to the study.

2. Participants' primary care doctors should be informed of their participation in this study, provided that participants:

(1) There are primary care doctors.

(2) If you agree, you can notify the primary care doctor.

PI is identified by the specified IRB. Before and during the study, PI must meet all requirements of IRB. The research shall not be started until the IRB has approved it. (See the materials on the responsibility of researchers for IRB in the Institutional Review Board module. )

PI is recognized as the specified IRB. PI must comply with all the requirements of IRB before and during the study. Research shall not be started before IRB approves it. (See the materials on the responsibilities of IRB researchers in the Institutional Review Board module. )

PI is responsible for ensuring that the research is carried out according to the research plan. He or she shall ensure that all scheme verifications are identified, recorded and reported according to the requirements of the sponsor and IRB. Repeated violations of the program may indicate the need for program revision, program change or additional training.

PI is responsible for ensuring that the research is carried out according to the research plan. He or she shall ensure that all violations of the agreement are identified, recorded and reported according to the requirements of the organizer and IRB. Repeated violations of the agreement may indicate the need to modify the agreement, change procedures or conduct additional training.

If the research involves the use of research drugs, PI is responsible for ensuring that the use of research drugs only conforms to the research plan and federal regulations; And the responsibility of researching products is maintained. (See related materials of experimental new drug module. )

If the research involves the use of test drugs, PI is responsible for ensuring that the test drugs are only used in accordance with the research protocol and federal regulations; And maintain the responsibility of testing drugs. (See related information of new drug research module. )

For clinical research using controlled study drugs, PI may need a medical license. When PI is not required to have a medical license, the responsibility of receiving or administering certain drugs, reviewing safety incidents and making independent medical decisions will be entrusted to qualified medical personnel, such as doctors, physician assistants, practical nurse or other qualified/licensed medical professionals. These appointed duties are recorded in the duty assignment log of the research center, and the appointed personnel can serve as deputy investigators. Consult local laws and regulations and regulatory agencies on medical licensing requirements for research using controlled drugs.

For clinical studies using controlled study drugs, PI may require a medical license. When PI does not need to hold a medical license, the responsibility of receiving or managing certain drugs, reviewing safety incidents and making independent medical decisions will be entrusted to qualified medical personnel, such as doctors, physician assistants, nurses or other qualified/certified medical professionals. These assigned tasks are recorded in the field task assignment log, and the assigned staff can serve as deputy investigators. Please consult local laws, regulations and regulatory agencies for medical licensing requirements for research using controlled drugs.

PI is responsible for ensuring compliance with the randomized and blinded procedures (if any) of the study.

PI is responsible for ensuring compliance with the randomized and blinded procedures of the study (if any).

PI is responsible for ensuring that the procedures for obtaining and recording informed consent conform to GCP and ethical principles derived from Helsinki Declaration.

PI is responsible for ensuring that the procedures for obtaining and recording informed consent conform to GCP and ethical principles derived from Helsinki Declaration.

PI is responsible for ensuring the accuracy, completeness, readability and timeliness of all research data reported to the sponsor.

PI is responsible for ensuring the accuracy, completeness, readability and timeliness of all research data reported to the organizers.

PI shall provide a written report on the research status to the sponsor and IRB at the request of each research institution.

When necessary, PI shall provide a written report on the research status to the sponsor and IRB of each institution conducting the research.

All serious adverse events must report to the organizer immediately. PI must also comply with regulatory requirements and report serious adverse events to IRB and regulators.

All serious adverse events must report to the organizer immediately. PI must also comply with regulatory requirements and report serious adverse events to IRB and regulators.

After the study is completed, PI is responsible for providing:

I. All required reports submitted to the sponsor institutions and regulatory agencies.

Ii. summarize the research results to the institutional review committee.

Ⅲ. Records and reports will be discussed in detail in the module of document and record preservation.

Ⅳ. serious adverse events is discussed in the module of participant safety and adverse events.

After the study is completed, PI is responsible for providing:

1. Submit all necessary reports to the organizers and regulatory agencies.

2. Submit a summary of the research results to the institutional review committee.

3. The file and record keeping module will discuss records and reports in more detail.

4. serious adverse events is discussed in the module of participant safety and adverse events.

If the research is suspended or stopped prematurely for any reason, PI shall be responsible for:

If the research is terminated or stopped prematurely for any reason, PI shall be responsible for:

I. Inform all participants in the study in time.

II. Ensure that all participants receive proper treatment and follow-up.

Iii. comply with all requirements for notifying the regulatory authorities.

1. Inform all participants in the study in time.

2. Ensure that all participants receive proper treatment and follow-up.

3. Comply with all requirements for notifying regulatory agencies.

The researcher assembled a project team to assist in all aspects of the research operation. In addition to the responsibilities listed by the principle researcher, other responsibilities of the scheme team usually include but are not limited to quality assurance, training and regulatory affairs.

The researchers assembled a project team to help study all aspects of the operation. In addition to the responsibilities of the main researcher, other responsibilities of the project team usually include but are not limited to quality assurance, training and supervision.

Quality assurance (QA) personnel are responsible for:

I. Review the scheme, and check the inconsistent and problematic wording that will increase the possibility of violating the scheme.

Review the monitoring report of on-site inspection to ensure that all problems found are properly and timely solved and conveyed to the investigation team.

Iii. Conduct on-site inspection on behalf of the organizer as required.

1. Review the agreement and check whether inconsistent and problematic wording will increase the possibility of violating the agreement.

2. Review the monitoring report of on-site inspection to ensure that all problems found are solved in an appropriate and timely manner, and communicate with the investigation team.

3. Conduct on-site inspection on behalf of the organizer as required.

The regulatory affairs personnel are responsible for:

I. Writing informed consent for research.

Ii. submit the proposal, consent documents and IRB documents to the IRB of the lead node, and make any modifications to these documents according to the requirements of the IRB.

Iii. Distribute the IRB-approved scheme, consent form and IRB documents to the participating institutions to help them prepare IRB applications.

Ⅳ. Prepare and distribute the list of items that must be possessed by participating venues, and

ⅴ. Provide supervision and guidance for the research site when necessary.

1. Write the informed consent of the research.

2. Submit the proposal, consent and IRB documents to the IRB of the lead node, and make any modifications to these documents according to the requirements of IRB.

3. Distribute the IRB-approved scheme, consent document and IRB document to the participating sites to help them prepare the documents submitted by IRB.

4. Prepare and distribute the list of items necessary to participate in on-site activities, and

5. Supervise and guide the research site when necessary.

This responsibility continues throughout the trial period, such as submitting program amendments.

This responsibility runs through the whole probation period, such as submitting program revisions.

Under the supervision of on-site PI, responsible for the research examples. Coordinators/assistants may include:

Provide examples of research responsibilities under the supervision of on-site PI. Coordinators/assistants may include:

I. Ensure accurate collection and reporting of research data.

Ii. report any research or participants' problems.

Iii. Maintain the regulatory documents of the research site.

Ⅳ. Cooperate with node quality assurance monitoring and data management personnel to identify and solve data and reporting problems.

1. Ensure accurate collection and reporting of research data.

2. Report any research or participants' problems.

3. Keep the regulatory documents in the research site.

4. Cooperate with the node quality assurance supervisor and data management personnel to identify and solve data and reporting problems.

The role of a research assistant usually also includes interacting with research participants by performing assessments (such as addiction severity index) and protocol procedures.

The role of research assistant usually also includes interacting with research participants through evaluation (such as addiction severity index) and protocol procedures.

Nurses, pharmacists and other staff are responsible for carrying out research procedures, such as? Agreements (for example, receiving and distributing drugs, conducting physical examinations, and implementing behavioral interventions) and agreements to evaluate and report adverse events to appropriate employees.

Nurses, pharmacists and other staff are responsible for implementing the research procedures described in the plan (for example, receiving and distributing drugs, conducting physical examination and providing behavioral intervention), and evaluating adverse events and reporting them to relevant staff.