- Guidance & Forms
- IND & IDE Support
- Clinical Trial Registration
- Report a Concern
Clinical Trial Registration and Transparency Support
Our experienced Information Disclosure Administrator provides training and resources concerning disclosure of information, documents, and data for clinical studies initiated by University Investigators. This includes submitting and maintaining clinical study registration and summary results information on ClinicalTrials.gov, disclosing study documents, and plans for sharing (de-identified) individual participant data for further research. Contact CTgov@pitt.edu if you have questions or need to establish an account.
The University of Pittsburgh is committed to complying with all applicable laws, regulations and policies governing submission of clinical study registration and results information to ClinicalTrials.gov. This includes, but is not limited to:
- Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy
Get the latest information on clinical trials from the U.S. National Library of Medicine.
Registration is an important aspect of clinical trials. Following step-by-step instructions will help you in your work.
Routinely monitoring a record is required and important for numerous reasons. If there's an issue with the record, the responsible party or designee is required to take immediate action to address all problem messages.
Criteria and deadlines for results submissions will help you plan your work.