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: What are some of the benefits that an investigator may gain from the PAM process?

Answer: PAM helps investigators maintain compliance, identify issues early, receive guidance, and access resources—supporting ethical research and effective study management.

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

Answer: Yes. Researchers are required to comply with post approval evaluations; however, we work with researchers to ensure that the time commitment is reasonable, and the timing works for all. PAVE evaluations ensure that studies adhere to approved protocols and regulatory standards, supporting responsible and ethical research conduct.

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: When will I receive information about any findings of the PAVE Evaluation?

Answer: The Final Evaluation Report will be made available within 7 to 10 business days after the exit interview in the same folder where study documents were uploaded.

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
• The lead researcher(s) of the study

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

Answer: The oversight committee (IACUC, IBC, or 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.