Clinical Trials Resources

Quality Assurance Program Contact

101 Technology Center, University Park, PA 16802
Phone: 814-865-1775 • Fax: 814-863-8699
Email: ORP-QM@psu.edu

The Office for Research Protections Quality Assurance Program conducts post-IRB approval reviews and supports investigators conducting FDA-regulated studies, conducting other clinical trials, and registering and reporting on ClinicalTrials.gov.

Office Directory

This page provides some curated resources to assist investigators doing clinical research.

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.

GCP Training & Clinicaltrials.gov Registration

If you are required to complete Good Clinical Practice (GCP) training, please see our see our instructions for how to access the training. If you need to register or report results in ClinicalTrials.gov, you can find guidance here.

Consent Form Posting

The Revised Common Rule, effective January 21, 2019, requires all studies meeting the defintion of a clinical trial and funded by a Common Rule department or agency to post an unsigned informed consent form on a publicly available website. For guidance on the consent form posting requirement, refer to our overview.

Regulatory Binder

See the Regulatory Binder – Documentation Checklist for assistance creating a Regulatory binder.

In addition to the checklist, 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 GCP documentation guidelines. For more information, please see our webpage for the eReg Binder: https://www.research.psu.edu/qm/eregbinder.