In August 2022, the Office of the Inspector General released an audit report that determined that the National Institutes of Health (NIH) “did not ensure that all NIH-funded Intramural and Extramural clinical trials complied with Federal reporting requirements for responsible parties to submit the results of clinical trials to ClinicalTrials.gov”(A-06-21-07000). As a result, NIH and NIH entities have begun sending out noncompliance letters to “Responsible Parties” who have not adequately reported their clinical trial results as required by the NIH Policy on the FDA Administrations Act (FDAAA) of 2007, section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)) and the Final Rule CFR 81 (September 16, 2016). The Responsible Party named in the Registration, is expected to make sure that research results are posted to ClinicalTrials.gov within one year of the trial completion date. The noncompliance letters are issued by the funding institute under the NIH. As such, the senders of these noncompliance letters vary.
Any researcher at a Penn State campus who receives such a noncompliance letter should contact the Quality Assurance Program (ORP-QM@psu.edu) and Office of Sponsored Programs (osp@psu.edu) as soon as possible. Similarly, any researcher at the College of Medicine should contact the Research Quality Assurance Program (Clinicaltrials.gov@pennstatehealth.psu.edu) and Office of Research Affairs (e-grants@pennstatehealth.psu.edu).
For researchers at University Park and the campuses, see the Quality Assurance Program webpage for more information about clinical trials registration in ClinicalTrials.gov. For researchers at the College of Medicine, refer to the Research Quality Assurance webpage.