NIH Applications for Clinical Trials and Clinicaltrials.gov

NIH issued a new policy to increase the availability of information about clinical trials via ClinicalTrials.gov. As part of that new policy, NIH grantees must certify compliance with federal regulations in applications and progress reports.  Grant applications and progress report for applicable clinical trials* require certification that clinicaltrials.gov requirements have been met.   

As explained by NIH in https://grants.nih.gov/clinicaltrials_fdaaa/certify-compliance.htm, the following information is required in NIH grant applications and progress reports for applicable clinical trials. 

For competing applications that include applicable clinical trial(s): 

• If a new applicable clinical trial is proposed or if the grant will support an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first patient), the Human Subjects section of the Research Plan must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. 
• If the competing application will support an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the Research Plan must include, under a heading entitled “ClinicalTrials.gov”, the ClinicalTrials.gov registry number (which is “NCT” followed by an 8-digit number, e.g. NCT00000418), the Brief Title (protocol title intended for the lay public), and the identity (name, organization) of the responsible party and their contact information (e-mail address-required for internal administrative use only). 

For non-competing continuation progress reports for a project that includes applicable clinical trial(s):

• If a new applicable clinical trial is proposed or if the progress report includes an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first subject), the Human Subjects section of the progress report must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. 
• If the progress report includes an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the progress report must include, under a heading entitled “ClinicalTrials.gov”, the ClinicalTrials.gov registry number (which is “NCT” followed by an 8-digit number, e.g. NCT00000418), the Brief Title (protocol title intended for the lay public), and the identity (name, organization) of the responsible party and their contact information (e-mail address-required for internal administrative use only).

* Applicable clinical trials generally include 1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and 2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance.

Please contact your college’s CGO for additional information on NIH’s requirement for grant applications and progress reports. 

Faculty who need assistance with registering in Clinicaltrials.gov or questions related to the corresponding reporting requirements for applicable clinical trials should contact Laura Ash, Institutional Clinicaltrials.gov Specialist, in the Center for Clinical and Translational Science at laura.ashe@uky.edu .