What needs to be included in grant applications and progress reports to provide certification?
• For competing applications (new and renewal) that include applicable clinical trials: the NCT number/s, Brief Title/s (as defined by ClinicalTrials.gov, see ClinicalTrials.gov “Registration” Data Element Definitions), and the identity of the responsible party (or parties) must be provided in the Human Subjects Section of the Research Plan. If a new applicable trial is proposed, the human subjects section of the research plan should include a statement that the application includes a trial which requires registration in ClinicalTrials.gov. The signature on the application of the Authorized Organizational Representative will now also assure compliance for the registration of any such trial. • When submitting a non-competing progress report that includes applicable trial/s: NCT number/s, Brief Title/s (as defined by ClinicalTrials.gov, see ClinicalTrials.gov “Registration” Data Element Definitions), and the identity of the responsible party (or parties) are to be included in the Human S
