Post Approval Monitoring

The Office of Research Compliance provides Post Approval Monitoring (PAM) of the following activities in order to verify that they conform to the applicable federal and state regulations. The intent of compliance reviews or Post-Approval Monitoring is to work in good faith with all UNTHSC researchers to facilitate research compliance. All not-for-cause PAM is random and the Principal Investigator will be given a 10 working day advance notice before initiation of the compliance review.

1. Investigator -Initiated research studies*
2. Controlled Substances Use in Research

*Compliance reviews are conducted on UNTHSC's IRB approved Investigator-initiated studies at least monthly and can include both routine, random, not-for-cause and for-cause compliance reviews. Refer to Chapter 20: OPHS / IRB Compliance Review Principles and Procedures for additional information related to Post Approval Monitoring and Investigator-initiated studies. For UNTHSC's complete standard operating procedures on human subject protection see the Office for the Protection of Human Subjects (OPHS).

The Office of Research Compliance (ORC) is committed to providing education and consultation regarding regulatory requirements, compliance obligations, and best practices.The ORC was created to assist researchers, faculty, and staff with complying with the various federal, state, and local regulations impacting research. Compliance with regulations ensures the safety of research subjects and the integrity of data.

Reporting 

Results of a compliance review will be shared with the Principal Investigator and maintained in a file. As needed, and in accordance with federal agency and university policies, appropriate institutional officials such as:  Department Chair, Vice President for Research, IRB Chairperson, GSBS Dean, and Chief Compliance and ERM Officer may also receive a copy of the compliance review report.