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The Office for Research Protections Quality Management program conducts post-IRB approval reviews and provides support for FDA-regulated human subjects research. The program also is the primary resource for investigators who are or may be conducting an NIH-funded "clinical trial," a "clinical trial" funded by other federal other agencies, and FDA-regulated "applicable clinical trials" (ACTs), as well as is responsible for administering the Penn State clinicaltrials.gov account.
Please contact us if you need help with the definitions or requirements for federally funded clinical trials or applicable clinical trials, help with registration or reporting in clinicaltrial.gov, and/or help with complying with FDA drug or device regulations.
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. The purpose of the reviews are to assess investigator compliance with the IRB-approved protocol and applicable regulations and policy, as well answer question investigators might have about regulations, policies, and processes related to humans subject protections.
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 conduct educational onsite visits, which you can request at ORP-QM@psu.edu.
FDA Drugs and Devices
Quality Management staff provide support for sponsor-investigators and potential sponsor-investigators, investigators who have developed an FDA-regulated drug or device study. We help researchers determine whether their study is FDA-regulated and whether their study requires an "investigational new drug" (IND) application or an "investigational device exemption" (IDE). We also help 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.
If you are conducting federally-funded human subjects research, you must know whether or not your research meets a definition of "clinical trial," as defined in NIH policy and federal regulations. If you are conducting FDA-regulated research, you must know whether or not your research meets the defintion of "applicable clinical trial" (ACT), as defined in federal regulations. Federally-funded and/or FDA-regulated humans subjects research that meets a definition of either term is subject to special compliance requirements.
The Quality Management program is the primary resource for investigators on the federal regulations, policies, and definitions pertaining to "clinical trials" and ACTs. The program can help investigators determine whether or not their research meets a federal definition of "clinical trial" or ACT, and when their research does, we support and monitor investigator compliance with federal requirements. Investigators can also contact us for advice on journal editorial requirements for clinical trials.
For more information, please see our webpage on the clinical trials and applicable clinical trials: https://www.research.psu.edu/qm/clinicaltrials.
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.
The Quality Management program can create an account for you and help you with study registration and reporting. Please email us at ORP-QM@psu.edu. If you are requesting a new account, please send the email from your Penn State email and include your office phone number.