As a condition of consideration for publication, the International Committee of Medical Journal Editors (ICMJE) now requires all new clinical research studies that begin enrolling subjects on or after July 1, 2005 to be entered in a public registry at or before the onset of subject enrollment. Although the ICMJE did not endorse a specific registry, they did describe criteria for a qualifying registry.
ClinicalTrials.gov, an existing registry, meets these criteria and has become the most widely used registry to meet the ICMJE requirement.
The "Sponsor" of the study is responsible for registering the trial in a public registry. Institutes within NIH are the Sponsors of the trials that they are funding. The Sponsor of industry-initiated and funded multi-center studies is the pharmaceutical company whose protocol you are following.
For investigator-initiated studies from our faculty, UNC is considered the Sponsor and the University is therefore responsible for registering those studies. UNC is a registered Sponsor at ClinicalTrials.gov, and the Office of Clinical Trials has designated a University Administrator for the University's ClinicalTrials.gov account.
Trials that should be registered on clincialtrials.gov
- Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation (Note: ICMJE requires Phase I if efficacy endpoints)
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance
Deadline(s) for Registering Trials
- ICMJE Policy – Study must be registered prior to enrollment of first subject. If an investigator wants to publish the data, this practice should be followed
- PHS Act – No later than 21 days after enrollment of the first subject. This is required by US Public Law and must be done
- To register on ClinicalTrials.gov, contact the University administrator in the UNC Office of Clinical Trials. For more information, please see research.unc.edu/offices/clinical-trials/data_res_oct_registering
Investigators holding an IND or IDE must submit to the FDA Form 3674 certifying that the study will be registered in clinicaltrials.gov. This form must accompany the initial IND or IDE submission as well as the addition of a new protocol to an existing IND or IDE. This is a new requirement as of December 2007. This is a Certification of Compliance that all requirements of the Public Health Service Act (42 USC§ 282(j)) have been met.