ClinicalTrials.gov Requirements

For non-NIH sponsored research, review the information provided in the Federally Funded (non-NIH) section. 

NIH Posting Requirement (FDAAA 801 Requirement)

Any NIH sponsored clinical trial requires that the investigator(s) register with ClinicalTrials.Gov, a publically accessible website that provides easy access to information for clinical studies on a wide range of diseases and conditions. Posting of all studies must be within 21 days of enrollment of the first participation but most journals require registration prior to enrollment of the first subject.

COUHES requires investigators wait until the study has been approval prior to registration.

Investigators must enter information about their study, ensure the information is correct, consistent with the COUHES approved protocol, and readily understood by the public, and keep the posting updated. Upon completion of the clinical trial, investigators must submit results in a timely manner. Visit How to Submit Your Results for details.

To request an access, visit PRS Administrator Contact Request Form. The Organization must be entered exactly as it appears on the list of organizations, Massachusetts Institute of Technology. For questions related to registration, contact the COUHES office.  

Visit ClinicalTrials.Gov for more information or ClinicalTrials.Gov FAQ for a list of commonly asked questions.

Required Consent Language

NIH funded Clinical Trials require the inclusion of the following language on the Informed Consent Form(s) (21CFR50.25(c)):

“A description of this clinical trial will be available on https://www.clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

Consent Forms Templates

Consent to Participate in Biomedical Research – NIH Sponsored Clinical Trial Only

Consent to Participate in Non-biomedical Research - NIH Sponsored Clinical Trial Only

For previously approved protocols, investigators must update the consent form with an Application for Changes to an Approved Protocol. Any changes to an approved protocol require review by COUHES.

Additional Posting Resources

The NIH provides a detailed walkthrough for investigators posting on ClinicalTrials.Gov. Follow the link for more information: NIH Grants & Funding

Investigators who have already registered their trial and wish to edit it can visit ClinicalTrials.Gov How to Edit Your Study Record for more information.

Federally Funded (Non-NIH)

For research conducted or supported by a Federal department or agency, excluding the NIH, investigators must post one IRB-approved consent form used to enroll subjects on a publically available Federal website. The posting must be made after the study is closed to enrollment and no later than 60 days after the last study visit by any subject.