ClinicalTrials.gov


NIH CHANGES  

Recent changes in the NIH definition of a clinical trial may now require that your study be registered at ClinicalTrials.gov.  

*NEW NIH CLINICAL TRIALS DEFINITION *

"A research study in which one or more human subjects are prospectively assignedprospectively assignedPROSPECI to one or more interventionsinterventionsi (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes."
DOES YOUR STUDY MEET THE NIH DEFINITION OF A CLINICAL TRIAL? 

 

health-related biomedical or behavioral outcomes.

*NIH FAQ ON THE DEFINITION OF A CLINICAL TRIAL*

*FOR COMPETING RENEWAL APPLICATIONS*

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,”
  • National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
  • Brief Title as listed in ClinicalTrials.gov, and
  • Name of the individual or entity responsible for registering the study for each study being conducted under the application. (As grantee, Augusta University designates the lead investigator of the trial as the responsible party.)

*FOR NEW APPLICATIONS*

New applications that include studies required to be registered must include as part of the Human Subjects Section of the Research Plan a statement that “This application includes a trial which requires registration in ClinicalTrials.gov.”  The study would then be registered, and the National Clinical Trial (NCT) number, Brief Title as listed in ClinicalTrials.gov, and the individual or entity responsible for registering the study for each study being conducted under the application will be part of the required Just-In-Time (JIT) information.  If a New 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.”  

*FOR NON-COMPETING PROGRESS REPORTS*

Non-competing progress reports that include studies that are required to be registered must include as part of the Human Subjects Section of the Progress Report the following items:  

  • A statement that “This application includes a trial which requires registration in ClinicalTrials.gov”
  • National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
  • Brief Title as listed in ClinicalTrials.gov and
  • Name of the responsible party for each study being conducted under the application.  (As grantee, Augusta 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 non-competing progress reports with budget start dates of April 1, 2008 or later (applications due on or after 2/1/08).

*FDA REGULATIONS SPECIAL REQUIREMENTS FOR IND, IDE, OR BLA STUDIES*

Studies conducted under an IND or IDE must include in the informed consent documents and the informed consent process a statement that clinical trial information for the study has been or will be submitted for inclusion in ClinicalTrials.gov as required by FDA regulations.

A certification must accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an IND, IDE, or BLA application or submission of a report, amendment, supplement or resubmission, such application or submission must be accompanied by a certification that all applicable requirements related to clinical trial registration have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers.

The official certification form, FDA 3674 entitled "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank is available on the FDA's website.

For sponsor held INDs, IDEs, and BLAs, the sponsor must provide the certification.  For investigator held INDs, IDEs, and BLAs, the individual holding the IND, IDE, or BLA must provide the certification.

Where can I find more information from the NIH about the requirement to register clinical trials?  https://grants.nih.gov/policy/clinical-trials.htm