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Post-Approval Monitoring

The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to work with humans or vertebrate animals begins with an approved protocol from Purdue’s Human Research Protection Program/Institutional Review Board (HRPP/IRB) or Institutional Animal Care and Use Committee (IACUC). However, research protections and record retention requirements continue throughout a project and after study closure.

It is critical to regularly monitor ongoing research involving human subjects and vertebrate animals. Both Purdue’s HRPP/IRB and IACUC maintain accreditations from world’s leading research protections organizations (AAHRPP and AAALAC, respectively). PAM is required to maintain these accreditations. The PAM process also encourages dialogue and education between the researcher and Purdue’s regulatory committees.

For more information about Post-Approval Monitoring, please see these links.

To preview the forms used during a Post-Approval Monitoring visit, please click on the links below.

Human Research Protection Program Pre-Visit Assessment Form
(Completed by PI)
Monitoring Form
(Completed by Monitor)
Animal Care and Use Committee Pre-Visit Assessment Form
(Completed by PI)
Monitoring Form
(Completed by Monitor)

Additionally, answers to common questions about the Post-Approval Monitoring process are provided below.

How are protocols chosen for Post-Approval Monitoring?

Protocols may be selected randomly, for cause, or by risk-based assessment to ensure proper oversight of approved protocols. At times when potential concerns or risks are identified, a post-approval monitoring visit may be conducted to ensure that study procedures are going as planned.

More information appears in the HRPP and IACUC SOPs.

What happens after a protocol is selected for a Post-Approval Monitoring visit?

In the case of random selection, the Monitor, typically a Purdue EVPRP staff member, will contact the Principal Investigator (PI) to schedule a time for the monitoring visit. The Monitor will provide a link to the pre-assessment form to learn more about the research activities (e.g. active status, access requirements, participant numbers). The pre-assessment form is optional, but is designed to save time and prepare materials in advance. The Monitor will establish a timeline for the review, ideally within five business days.

Who should be present during a Post-Approval Monitoring visit?

The PI and relevant research personnel responsible for data and recordkeeping should be present during the Post-Approval Monitoring visit. The PI is responsible for the activities associated with the study and will be expected to serve as the primary contact.

How is the Post-Approval Monitoring visit conducted?

The Monitor will meet with the PI and any identified members of the research team. In most cases, the posted forms (above) will be used for the visit. PIs may view these forms in advance to obtain a better understanding of the questions that will be covered and materials to be reviewed during the visit.

My research protocol is inactive. Do I need to complete a Post-Approval Monitoring visit?

Yes, if the research has not started, the Monitor may assess the status and help an investigator to determine any next steps.

If the research is ending, the Monitor will need to review study records and document retention requirements with the PI and research team.

What happens if there are issues or concerns identified during Post-Approval Monitoring?

Once the monitoring visit is complete, the Post-Approval Monitor will provide the PI with summarized information. Any discrepancies or points to resolve should be noted by the PI to the Monitor within 15 business days. The summary will be sent to the IRB or IACUC representatives for review. If any corrective actions are required, the IRB/IACUC office will inform the PI.

The team anticipates that most visits will be educational and informative based on the common goal to protect human research participants and/or animal welfare.

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