Quality Management

 

The Office for Research Protections Quality Management program conducts post-IRB approval reviews and provides compliance support for clinical trials. The program is the primary resource for investigators conducting FDA-regulated research, federally-funded clinical trials, and is responsible for administering the Penn State clinicaltrials.gov account.

Clinical Research

The Quality Management program offers assistance and resources for investigators conducting clinical trials.

Clinical Research Guidebook: In partnership with the Social Science Research Institute and the College of Medicine, the program maintains a clinical research guidebook targeted toward clinical research conducted outside of the College of Medicine. Visit the guidebook.

FDA Drugs and Devices: The program helps investigators determine whether their research is FDA-regulated and maintain compliance with FDA regulations, including providing support for FDA submissions. If you are an investigator conducting human subjects research and have a question about FDA regulations, contact us at ORP-QM@psu.edu.

Federally-Funded Clinical Trials: The program offers compliance support for federally-funded clinical trials, including NIH-funded studies meeting its definition of a clinical trial. See more about federaly-funded clinical trials or contact us to determine whether your study meets a federal definition of clinical trial.

ClinicalTrials.gov: The Quality Management program administers the Penn State institutional account for clinicaltrials.gov. We support investigators using clinicaltrials.gov and monitor the compliance of their records with federal law, NIH policy, and Penn State policy.  We have information, including guidance and University policies, on the Quality Management page for clinicaltrials.gov: https://www.research.psu.edu/qm/ctregistration

To create a clinicaltrials.gov account for registration, email us at ORP-QM@psu.edu. Please send the email from your Penn State email and include your office phone number.

eRegulatory Binder: Penn State offers both a single-site and multi-site Electronic Regulatory (eReg) Binder template for investigators. The eReg Binder can help clinical researchers comply with FDA regulations and documentation guidelines for good clinical practice (GCP) and can help any researcher meet regulatory requirements and establish a high standard of record-keeping for human subjects research. Access the eReg Binder.

Post-IRB Approval Review 

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 here: https://www.research.psu.edu/qm/postapprovalreviews

We also conduct educational onsite visits, which you can request at ORP-QM@psu.edu.