Post Approval Monitoring (PAM)

Quality Assurance is maintained through PAM. It can be conducted on any IRB protocols that are currently active, inactive, closed and expired. 

The PAM team is a part of the Human Research Protection Program (HRPP) and IRB. It works closely with IRB staff, IRB and investigators to ensure the protection of human research participants and facilitate compliance with federal regulations and university rules. It also assists to review processes and procedures to improve overall program and committee functions and provides education and outreach for those managing and conducting human subjects research at Texas A&M-San Antonio.

We conduct routine reviews of protocols of active human research studies. Studies are selected for monitoring according, but not limited to, the following criteria:

• Risk level
• Studies enrolling vulnerable populations
• Randomly selected
• Studies requiring more than annual review by the IRB.
• Studies involving investigational new drugs (INDs) or devices (IDEs).
• New or inexperienced investigator or research staff

For-cause audits may be triggered by one of the following events:

• Participant or other complaints
• Ongoing corrective action monitoring
• When reported new information is a potential non-compliance.
• When there are concerns regarding whether the rights and welfare of participants enrolled in research are adequately protected.
• When there are concerns about the validity or integrity of the data collected