Requirements for Registering with Clinicaltrials.gov
Do I need to register with Clinical Trials.gov?
FDA Required Registration: The Food and Drug Administration (FDA) requires study registration along with results and adverse event reporting for all phase II - IV interventional drug, biologic or device trials ("applicable clinical trials"). “Applicable Clinical Trials” include the following:
- Trials of drugs or biologics: controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to FDA regulation. Registration may be required for drugs and devices even if an IND or IDE is not required.
- Trials of devices: 1) controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post-market surveillance required by FDA.
National Institutes of Health Registration:The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA. Grant awardees MUST register if their study includes:
- one or more prospectively assigned human subjects,
- to one or more interventions (which may include placebo or other control), or
- to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (See NOT-OD-15-015: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).
International Committee of Medical Journal Editors' Requirements: Publication of interventional health outcome studies in journals adhering to the International Committee of Medical Journal Editors' (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals is contingent on timely study registration. A study requires registration for ICMJE purposes if it involves the prospective assignment of subjects to a health-related intervention that investigates the cause-and-effect relationship between the health-related intervention and any health outcome.
For more information about what trials must be registered at ClinicalTrials.gov and timelines for registration, see Clinical Trials Registration & Results Reporting.
Who is Required to Register the Trial with ClinicalTrials.gov?
Under certain circumstances a University of Wisconsin investigator can be required to register and provide periodic updates for some clinical trials at ClinicalTrials.gov. If the trial must be registered at ClinicalTrials.gov, the University of Wisconsin - Madison investigators are responsible when one or more of the following conditions is met:
- The trial is initiated by a UW-Madison investigator
- The trial is federally sponsored and UW-Madison is the only study site, OR the study's coordinating center
- The UW-Madison investigator is the holder of an Investigational New Drug (IND) application for the agent being studied, OR the IRB has determined that the agent being studied is IND exempt; or
- The UW-Madison investigator is the holder of an Investigational Device Exemption (IDE) for the device being studied, OR the IRB has made a non-significant risk (NSR) determination for the device being studied.
For assistance in registering the trial please contact CT.gov_HELP@clinicaltrials.wisc.edu.