How do the FDA registration requirements affect NIH funded studies?
Competing renewal applications that include studies that are required to be registered must include as part of the Human Subjects Section of the Research Plan the following items: • A statement that “This application includes a trial which requires registration in ClinicalTrials.gov,” • The National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number) • Brief Title as listed in ClinicalTrials.gov, and • The name of the individual or entity responsible for registering the study (responsible party) for each study being conducted under the application. (As grantee, Thomas Jefferson University designates the lead investigator of the trial as the responsible party.) If the application does not include studies that are required to be registered the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.” These requirements apply to all competing applications submitted
Related Questions
- With the advent of electronic submission of applications to NIH, where can I get information on pre-submission requirements such as registration?
- What are the NIH Requirements for ClinicalTrials.gov Registration Information in Applications and Progress Reports?
- Is existing UW practice affected by the new FDA/NIH registration requirement?
