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 studies conducted by a sponsor-investigator. 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, even fruits and vegetables, can be defined as a drug by the FDA. If you are testing a food for reasons other than for taste or consumer preference, the IRB requires a written determination from the FDA. You will need to either submit an "Investigational New Drug" Application (IND) 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 device is a class project and you will not be doing anything with it once the class ends.
Clinicaltrials.gov is a registry of "applicable clinical trials" and other studies. What consitutes an applicable clinical study is defined by federal law and, for NIH awardees, NIH policy. Also, a number of journals require registration for publication.
The registry serves a number of purposes, including to make studies and their outcomes more transparent and to improve participant access to clinical trials. For many applicable clinical trials, you must not only register a study but also report findings and other study-related information.
When registration is required by law because a study involves an IND or IDE, the "responsible party," the party reponsible for compliance, is the sponsor. At Penn State, when registration is required for NIH awardees, the prinicipal investigator is the reponsibile party. The responsible party must
- Register the trial no later than 21 days after enrollment of the first participant;
- Update the registration at least once every 12 months; and
With some exceptions, submit summary results no later than 12 months after the final subject received the final study intervention
Quality Mangement can help you with the registration and reporting processes within the clincialtrails.gov "protocol registration system" (PRS).
Clinicaltrial.gov also offers a collection of informational and instructional materials on the PRS.
The Penn State policy on Quality Management reviews is RP05 - Research Quality in Human Participant Research. Also, please see HRP-103 - Investigator Manual.