Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs)

Question: What is post-approval monitoring?

Answer: Post-approval monitoring is the ongoing process of ensuring that approved research studies continue to follow their protocols, regulatory requirements, and ethical standards. It helps identify and address any issues early, supporting researchers in maintaining compliance and safeguarding research integrity.

Question: Are PAM or PAVE evaluations announced?

Answer: Yes, evaluations are always announced.

Question: How are studies chosen for evaluation?

Answer: Most study evaluations are random, and the studies are chosen using a random number generator. Occasionally, a committee (e.g., IRB, IACUC, IBC) may select a study for evaluation.

Question: What should I expect during the PAM or PAVE process?

Answer: See the PAVE Checklists for guidance on what will be asked/observed during a PAVE visit.

Question: As a researcher, am I required to comply if selected for a PAVE evaluation?

Answer: All investigators are expected to comply with post-approval evaluations; however, we work with researchers to ensure that time commitment is reasonable, and the timing works for all.

Question: What aspects of a study will the PAVE program review?

Answer: The PAVE Program reviews key aspects of a study to ensure alignment with the approved protocol and regulatory requirements. This includes participant recruitment and consent, data collection and management, use of animals or biohazards, adherence to safety procedures, and documentation accuracy.

Question: Does the Principal Investigator need to be present for all or part of the evaluation or can this be delegated to another member of the study staff?

Answer: The Principal Investigator (PI) should, ideally, be present for the entire evaluation to ensure accurate information and address any questions. While study staff can assist, the PI remains ultimately responsible for the study’s compliance, making their presence crucial to maintaining accountability and supporting adherence to regulations.

Question: How long will it take to complete the self-assessment and upload documents?

Answer: This will depend on the organization of the study team. The PAVE staff estimate it will take between 30 minutes and 2 hours.

Question: Who will receive copies of the final PAVE Evaluation Report?

Answer: The final report is always distributed to the committee with oversight of the study (e.g., IRB, IACUC, IBC) and the principal investigator of the study.

Question: Who ultimately makes decisions or determinations regarding any evaluation?

Answer: The oversight committee (e.g., IACUC, IBC, IRB) retains authority to make determinations and require any potential actions (e.g., submission of protocol amendment, revision of documentation) that may be needed from the Principal Investigator, based on evaluation findings. As always, the PAVE team is ready to assist the PI and laboratory staff with completion of any actions.

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Post Approval Verification & Education Research Compliance Research Protections