Quality Assurance Program

The Quality Assurance 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 liaison between investigators and the IRB.  Additionally, the Quality Assurance 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, ancillary reviews, post-IRB approval reviews, and best practice recommendations.

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

Clinical Research

The Quality Assurance 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 research can be found on our clinical trial support page.  Any questions regarding clinical trials or FDA-regulations can be directed to the Quality Assurance 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 Quality Assurance 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.

There are three different types of post-IRB approval reviews: routine, directed, and abbreviated. In most cases, post-IRB approval reviews or audits are able to be conducted remotely.  However, depending on the nature of the study and the audit, an in-person visit from the Quality Assurance team may be required. 

Ancillary Review

Ancillary review assists the IRB with matters related to research feasibility, risk, regulatory requirements and research compliance.  When requested by the IRB, the Quality Assurance team conducts ancillary reviews of studies that may involve investigational drugs (IND) and devices (IDE) as defined the FDA regulations, also referred to as IND and IDE audits.  The purpose of the ancillary review is to evaluate the applicability of the FDA's IND/IDE requirements.