Quality Assurance/Post Approval Monitoring Program
What Do we Do?
The Quality Assurance/Post Approval Monitoring team is a part of the Human Research Protection Program (HRPP). It works closely with the HRPP/IRB staff, the Institutional Review Boards and investigators to ensure the protection of human research participants and facilitate compliance with federal regulations and university rules. It also assists and collaborates with the HRPP and IRBs to review processes and procedures to improve overall program and committee functions and provides education and outreach for those managing and conducting human research at Texas A&M.
What Types of Reviews do we Conduct?
Types of protocols reviews include routine reviews, investigator-initiated reviews, for-cause reviews, IRB/HRPP directed reviews, and others. Reviews have several components including an evaluation of the history of the protocol, interviews, and a report of any findings. The most common types of reviews are routine monitoring and directed/for-cause reviews both of which are outlined below.
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
Directed/ For-Cause Review
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
Overview of the Review Process
How Will I be Notified That my Protocol has been Selected for a Review?
You will be notified via email of the monitoring visit to determine availability of the investigators and allocation of resources such as files, space, and/or access to electronic records. The email will specify which protocol(s) is to be reviewed.
What will Happen on the Day of the Review?
On the day of the review, the study files will be reviewed and interview(s) will be conducted with the research team.
What Happens Next?
Upon completion of the monitoring visit, you will be debriefed regarding findings, recommendations, and next step. A written report will be emailed to you. If the report identifies findings that need to be reported to the IRB, the findings, a response, and a corrective action, when necessary, will need to be submitted via iRIS using the “Reportable New Information” form and/or other forms as noted in the report.
Preparing for a Monitoring or Audit Visit
- Ask any questions you may have before, during, and after the visit.
- Have study documents ready (this includes but is not limited to: recruitment material, informed consent, assent and HIPAA form(s) for all enrolled and screened participants, data collection instruments, database, all study related regulatory documents, as applicable).
- Allocate enough time to prepare for the review. This includes ensuring that all study documents are available and easily accessible on the day of the monitoring visit.
- Utilize available resources.
For questions, please contact:
Kory Douglas, PhD