As a condition of consideration for publication, the International Committee of Medical Journal Editors (ICMJE) 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/update_may05.html.
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. 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 Monica Coudurier from the Office of Clinical Trials, is the designated 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.
A study must have been submitted to an IRB for review prior to registry although approval is not required prior to ClinicalTrials.gov protocol record submission.
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. However, ultimate responsibility for record accuracy lies with the “Responsible Party” which is usually the Principal Investigator (PI).
An individual user account will need to be established at ClinicalTrials.gov by the University Administrator for the Principal Investigator (PI) of the study and designees requiring record access. Send an e-mail to firstname.lastname@example.org or email@example.com providing the user’s name, department, telephone number, and e-mail address. The user account will be created within ClinicalTrials.gov the same day if at all possible, and within a very few minutes of the user account set-up, the new user will receive an e-mail from ClinicalTrials.gov providing the login details and temporary password.
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.
Once the information is entered and the individual updates the record status from “In Progress” to “Complete”, an automated system e-mail is sent to the University Administrator (Office of Clinical Trials) advising that the record is ready to review, edit as necessary, and then approve and release for viewing at ClinicalTrials.gov. Once released, ClinicalTrials.gov will perform a system validation and quality assurance review. For protocol records this usually occurs within 2 to 5 days of release. For records containing results, this process may take up to 30 days. After completion of their review, ClinicalTrials.gov will assign an NCT number and make the record (or updates) publically available for viewing. Until this occurs, no one outside of UNC can see the record or updated information. A study is not considered to be registered until the QA process has been completed and the NCT number has been assigned. Please allow adequate time for this process. In order to qualify for publication consideration, enrollment should not begin until this entire process has been completed.
The Principal Investigator is responsible for maintaining the accuracy of the information on the registered trial. This includes updating the information as appropriate, minimally every 6 months or whenever a significant change occurs, and noting when enrollment ceases.
Please do not hesitate to contact Monica Coudurier should you have any questions about this important procedure.