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Post Approval Monitoring is an examination of the research facility and study documents to assure that human subjects are protected, and the investigator is in compliance with applicable University and Federal regulations. Conducting post approval monitoring will help to ensure that appropriate applications and supporting documents are executed as approved, any changes or adverse events are reported, and the consent forms are approved.

Some possible benefits that may be gained from a review include but are not limited to:

  • increased understanding of the regulations that guide all our research projects

  • increased communication concerning updates to federal and university regulations

  • access to resources and individuals to clarify the federal and university regulations

The majority of protocols are selected randomly. Projects whose subjects are at a greater risk have a higher chance of being selected. If a protocol has been selected, it does not necessarily mean the investigator is doing something wrong.
Protocols can be selected for-cause from a complainant (study subject, study personnel, anonymous, etc.).

If your documents are complete and organized, the review will take about thirty minutes to one hour. If an investigator is not prepared, the review may take several hours.

The audit assessment tool that is used is depended on whether your protocol is expedited or full board. When the PAM representative arrives, you will be asked to pull records / files and present the storage location and security methods. The scope of review varies greatly depending on the research, but may include:

 

  • Record retention and security of consent documents and data collection instruments (e.g., surveys, and videotapes)

  • Appropriate use of approved supporting documents

  • Risk assessment

  • Study procedures consistent with application

  • Consent process

 

There are several actions that could result from a PAM review. They include:

  • Compliant, no follow up needed.

  • Minor deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within one month and emails the document back to the PAM officer.

  • Significant deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within the specified time and emails the document back to the PAM officer.  Furthermore, the investigator will be reviewed again within six months to assure compliance.  The IRB will be notified of significant violations.

About a week from the review date.

It is preferred; however, you may designate a representative if you cannot attend.