Clinical Trial Registration

All NIH-funded clinical trials and applicable FDA-regulated clinical trials are required to register and submit result information to Clinicaltrials.gov, per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information and Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) " These policies help to ensure that clinical trial information and the results are made publicly available in a timely manner.

Also, the International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.

Pitt’s Education and Compliance Support for Human Subject Research Office has an Information Disclosure Administrator who is able to provide training, resources and support concerning disclosure of information, documents, and data for clinical studies initiated by University Investigators.

Clinical Trials

Clinicaltrials.gov

NIH Policy on Dissemination of NIH-Funded Clinical Trial Information 

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) 

International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy

Education and Compliance Support for Human Subject Research Office

https://grants.nih.gov/policy/clinical-trials.htm