Skip navigation.

The Office of

Clinical Trials

Clinical Trials Links:

Contact us:

1109-A Bioinformatics Bldg.
130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax

Registering an Investigator-Initiated Clinical Trial in a Public Registry

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. The full text of the ICMJE "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" can be found at http://www.icmje.org/. Section III.J addresses "Obligation to Register Clinical Trials." In May, 2005, ICMJE issued an "Update On Clinical Trials Registration," which can be found at http://www.icmje.org/clin_trialup.htm.

Although the ICMJE did not endorse a specific registry, they did describe criteria for a qualifying registry. ClinicalTrials.gov, an existing registry, meets those criteria and has become the most widely used registry to meet the ICMJE requirement. ClinicalTrials.gov allows organizations and individuals to provide the data requested by ICMJE, which has adopted the World Health Organization (WHO) minimal registration data set.

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. The University is a registered Sponsor at ClinicalTrials.gov, and Barbara Longmire, Director of the Office of Clinical Trials, is the designated University Administrator for the University's ClinicalTrials.gov account.

The process for registering individual studies is described below. Remember, this pertains only to investigator-initiated studies.

  1. IRB approval of the clinical trial is a prerequisite for registration.
  2. UNC's IRB does not review the data registered for a given trial. This review is performed by the University Administrator for UNC's ClinicalTrials.gov account.
  3. An individual user account will need to be established at ClinicalTrials.gov by the University Administrator for the Principal Investigator (PI) of the study. Send an e-mail to Barbara Longmire providing the PI's name and e-mail address. The request will be posted to ClinicalTrials.gov the same day if at all possible, and within a very few minutes of the request the PI will receive an e-mail from ClinicalTrials.gov providing their login and temporary password.
  4. The PI or the PI's designee will enter specific information about the study (the "minimal registration data set" referenced above) at the ClinicalTrials.gov website. ICMJE's May, 2005 "Update on Trials Registration" stated, "We will consider a registration data set inadequate if it has missing fields or fields that contain uninformative terminology." The complete data set is described in this PDF. All of the information on this document is taken directly from the ClinicalTrials.gov website.
  5. Once the information is entered and the individual exits the site, an e-mail is sent to the University Administrator (Office of Clinical Trials) asking the University Administrator to review the information posted, edit as necessary, and then approve for actual viewing at ClinicalTrials.gov. This University Administrator review is an important step in avoiding inadvertent violations of any confidentiality provisions in the Clinical Trial Agreement that the University has signed.
  6. The Principal Investigator is responsible for maintaining the accuracy of the information on the registered trial. This includes updating the information as appropriate, and noting when enrollment ceases.

Please do not hesitate to contact The Office of Clinical Trials or Barbara Longmire should you have any questions at all about this important procedure.

See also: ClinicalTrials.gov Registration Requirements