The Office for Research Protections Quality Management Program conducts post-IRB approval reviews. We provide support and education for researchers working with the FDA and conduct pre-IRB approval reviews of studies involving FDA-defined sponsor-investigators. We also help investigators with their clinicaltrials.gov registration and reporting requirements.
Contact us if you need help working with the FDA, clinicaltrials.gov, or would like to schedule a post-IRB approval educational visit.
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.
We typically conduct routine (not-for-cause) post-approval reviews, but the IRB sometimes directs us to review a study. Reviews may be comprehensive or may target specific study components. If your study is selected for a onsite visit, we will give you complete details about the review before we arrive.
We also welcome requests for educational onsite visits. Contact us at ORP-QM@psu.edu.
INDs, IDEs, and Sponsor-Investigators
Quality Management staff provide support for sponsor-investigators and potential sponsor-investigators. Usually, the sponsor is a drug company or medical device manufacturer, and the company or manufacturer designs a study and pays researchers to conduct it. In this situation, the company or the manufacturer deals with the FDA. If a researcher is a sponsor-investigator, he or she has to deal with the FDA.
We help researchers determine whether their study requires an "investigational new drug" (IND) application or an "investigational device exemption" (IDE), and we help sponsor-investigators with FDA compliance.
Furthermore, a Quality Management Ancillary Review is mandatory prior to IRB approval for all sponsor-investigator IND and IDE studies. The purpose of the Ancillary Review is to educate sponsor-investigators about their additional responsibilities when holding an IND or IDE, if they are new to FDA regulations, and to asssess the suitability of the research team and site for conducting drug or device research.
Foods and Dietary Supplements
Dietary supplements and food may be defined as a drug by the FDA. If you are using a dietary supplement or food as part of an investigation of biomedical outcomes, the IRB requires a written determination from the FDA. You will need to either submit and have approved an IND application or get a written statement from the FDA that an IND is not required.
If you are testing a device on individuals or human specimens, you need to submit a protocol to the IRB, and your study may be FDA-regulated. One exception is if the research involving a device is a class project and you will not be doing anything with it once the class ends.
The Quality Management Program administers the Penn State institutional account for clinicaltrials.gov. We have more information about study registration on the Quality Management page for clinicaltrials.gov: https://www.research.psu.edu/qm/clinicaltrials.
Clinicaltrials.gov is a registry of studies and their results. Any researcher can choose to register a study on the site, but some studies are required to be registered by federal law and, for NIH awardees, NIH policy. Also, a number of journals require registration for publication.
The Penn State policy on Quality Management reviews is RP05 - Research Quality in Human Participant Research. Also, please see HRP-103 - Investigator Manual.