The PAVE program conducts post approval evaluations, digital reviews, exit interviews, and on-site visits of active research protocols to corroborate alignment, compliance, and identify areas of improvement. The goal of post-approval evaluations is to confirm by observation and documentation comparison, an accurate and consistent protocol performance, conducted in accordance with an IRB, IACUC, or IBC approved protocol.

There are two types of evaluations: routine and for-cause evaluations.

ROUTINE EVALUATIONS        

Routine evaluation of a study typically occurs once every three to five years and studies are chosen using random number generators. Once a study is selected for an evaluation, the principal investigator (PI) will receive notification from PAVE that their study has been selected for an evaluation. The PI is asked to complete the self-assessment checklist and either upload necessary study documentation to an assigned shared folder or schedule a meeting with PAVE staff to have them view the study documentation in person, within X days.  The PAVE staff review all documentation, including the approved version of the study protocol, and schedule an in-person or virtual exit interview with the PI.

FOR-CAUSE EVALUATIONS 

For-cause evaluations of a study occur because of a request from either the IRB, IACUC, or IBC. Once the study has been selected, the principal investigator will receive notification from PAVE that their study has been selected for an evaluation. The PI is asked to complete the self-assessment checklist and either upload necessary study documentation to an assigned shared folder or schedule a meeting with PAVE staff to have them view the study documentation in person, within X days.  The PAVE staff review all documentation, including the approved version of the study protocol, and schedule an in-person or virtual exit interview with the PI.

OUTCOMES OF PAVE EVALUATION

Upon completion of evaluations, final reports are shared with the relevant oversight committees (e.g., IACUC, IRB, IBC) and the PI. Outcomes vary based on results and committee review and may include:

• No action, study is fully compliant
• Minor corrective actions to study procedures needed by PI
• Amendment to protocol must be submitted by PI
• Education or additional training is needed for the PI or study team
• Potential actions from the oversight committee (e.g., IACUC, IRB, IBC)

Post Approval Verification & Education QUick LInks:

Post Approval Verification & Education Research Compliance Research Protections