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PAM Audit ChecklistOffice of Research Compliance (in affiliation with the North Texas Regional Institutional Review Board) Post Approval Monitoring (PAM) Audit Checklist Date of Audit: ___ Name of

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Start by gathering all the necessary information and documents required for the specific post-approval model.

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Regulatory authorities may require sample models of post-approval to assess the safety and efficacy of a product post-market approval.

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What is sample models of post-approval?

Sample models of post-approval are representations or examples of the changes made to an approved drug or medical device after it has been granted approval by regulatory authorities.

Who is required to file sample models of post-approval?

The manufacturer or sponsor of the drug or medical device is required to file sample models of post-approval.

How to fill out sample models of post-approval?

Sample models of post-approval can be filled out by providing detailed descriptions and documentation of the changes made to the approved product.

What is the purpose of sample models of post-approval?

The purpose of sample models of post-approval is to ensure that any changes made to approved drugs or medical devices meet regulatory requirements and do not pose risks to patient safety.

What information must be reported on sample models of post-approval?

Information that must be reported on sample models of post-approval includes the nature of the changes, the reasons for the changes, and supporting data or evidence.

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