The Journey of Post Approval Evaluations

The PAVE Unit 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.

Who Conducts Evaluations: Trained PAVE staff members conduct post approval verification activities.

• Routine Selection: Randomly selected protocols, prioritized by risk, funding, and personnel changes. PI is notified directly by the PAVE Unit.
• For-Cause Selection: Triggered by committee requests, concerns, or suspected noncompliance reports. Formal notification is issued by the oversight committee.

How Evaluations Are Conducted: PAVE staff members review study documents and procedures, visit the research site, meet with the Principal Investigator, and provide feedback based on audit findings.

Reporting: Final Reports are provided within 7-10 business days after the exit interview. All reports are shared with PIs and pertaining oversight committees.

The following flowchart outlines the process involved in a routine PAVE evaluation. This process is designed to be supportive and educational, with follow-up support, training, and recommendations tailored to the specific needs of each study.

In the case of for-cause evaluations, the following flowchart illustrates the process initiated in response to specific concerns or reports. This evaluation is designed to address issues constructively, providing tailored recommendations and support to resolve identified challenges.

Final Oversight Determinations and Follow-Up Actions

Upon completion of evaluations, reporting packages are shared with the relevant oversight committees (IACUC, IRB, IBC). These committees hold full authority to review findings, make classifications, recommend actions, and issue regulatory decisions. Outcomes vary based on results and committee review.

Possible outcomes include:

• No Action Required: Study is fully compliant.
• Corrective and Preventive Action (CAPA) Plan: Investigator must outline steps to address and prevent issues.
• Education or Retraining: Additional training required for the investigator or study team.
• Protocol or Consent Modification: Changes needed to enhance compliance or participant protection.
• Increased Monitoring: Study placed under enhanced oversight or more frequent evaluations.
• Reporting to Regulatory Agencies: Serious findings reported to appropriate agencies or institutional officials. *
• Suspension or Termination: Study halted due to serious or ongoing noncompliance or safety concerns. *

*Such outcomes are rare and are applied only in instances of serious non-compliance.