Quality Management Program

The Research Quality Management program seeks to ensure investigator and institutional compliance with federal and state regulations governing human research, and is independent from the IRB.  In this role, the program acts as a liason between investigators and the IRB.  Additionally, the Research Quality Management program offers assistance and resources for investigators for all stages of research planning and implementation, including those conducting clinical trials.  This is accomplished by providing ongoing support, education and study management tools, post-IRB approval reivews, and best practice recommendations.

Educational onsite visits can be requested by emailing ORP-QM@psu.edu.

Clinical Research

The Research Quality Management program has developed several resources in order to support investigators who must comply with the federal regulations and policies pertaining to clinical research. These resources include:

Additional information about clinical reserach can be found on our clinical trial support page. Any questions regarding clinical trials or FDA-regulations can be directed to the Quality Management program. Contact us at ORP-QM@psu.edu or 814-865-1775. Researchers affiliated with the College of Medicine, should contact clinicaltrials.gov@pennstatehealth.psu.edu for questions about ACTs and NIH-funded clinical trials. 

Post-IRB Approval Review

Post-IRB approval reviews are conducted in an effort to ensure the highest level of research participant protections. The Research Quality Management program is separate from the IRB, and post-approval reviews are distinct from IRB continuing reviews and include an assessment of the IRB, as well as the study team. All protocols approved or determined exempt by the IRB may be selected for post-IRB approval review. These reviews may be an announced onsite visit, an investigator self-assessment, or both. Find more about post-IRB approval reviews.