Information Resources for NIMH Researchers Conducting Clinical Trials
Registering Your NIMH-Sponsored Clinical Trials With ClinicalTrials.gov
Why should you register your study with ClinicalTrials.gov?
There are several reasons: it may be mandatory for certain types of studies (see PRS and U.S. Public Law 110-85), some scientific journals require registration prior to publication of results, and doing so can increase recruitment.
How do I register a study in ClinicalTrials.gov?
The NIMH facilitates the registration of NIMH-sponsored trials by using the National Library of Medicine's (NLM) Protocol Registration System (PRS). In order to create and update your trial record, you or your designee will need to have an NIMH user account (free of charge) with the NLM's PRS. To obtain a new user account, go to the PRS website.
In order to register your trial, you will need to specify that it is supported by NIMH and has IRB approval. Complete instructions are available from the ClinicalTrials.gov ClinicalTrials.gov Reference Guide for NIMH Researchers (Revised April 2008; PDF file, 16 pages). Should you have any questions or problems regarding the PRS, contact the NIMH ClinicalTrials.gov Records Coordinator.
What other guidance is available from NIH regarding ClinicalTrials.gov?
From the NIH Office of Extramural Research:
- Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports (NOT-OD-08-023)
- FAQs - Clinical Trials Registration in ClinicalTrials.gov
- Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration (NOT-OD-08-014)
