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ICMJE Registration Information
What is the Requirement?
The International Committee of Medical Journal Editors (ICMJE) announced as a prerequisite to publish study results in ICMJE member journals your clinical trial must be entered into a registry that meets the ICMJE’s minimal registration data set of 20 items. Details of this requirement can be found at the International Committee of Medical Journal Editors Web site.
Also available is DSR’s FYI which discusses Clinical Trial Registrations.
Where do you Register?
To date the only known registry that meets the ICMJE stipulated data set is ClinicalTrials.gov, a service of the NIH’s National Library of Medicine.
To find out more about the Protocol Registration System (PRS) at ClinicalTrials.gov, visit the PRS Information Web site. (top)
What is the Purpose of Registering a Trial?
As described on the ICMJE Web site, the purpose is “to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making,” and to foster conditions in which decisions about care “rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish.” (top)
Who Registers the Trial?
The PI is responsible for ensuring that registration requirements are met. Many sponsors will do the actual registration work for the PIs, but it is still the PI’s responsibility to ensure that the registration has been accomplished. Before enrolling subjects, investigators should check the registry indicated by the sponsor to ensure that all 20 data elements as required by the ICMJE have been included. (top)
Can DSR help Register a Trial?
Registering a clinical trial on ClinicalTrials.gov or even making the determination on whether a clinical trial needs to be registered can seem overwhelming. In order to facilitate faculty registration of clinical trials on ClinicalTrials.gov, DSR has assigned Brian Prindle the role of Protocol Registration System Administrator for the University of Florida in the ClinicalTrials.gov system.
As the central point of contact for ClinicalTrials.gov, we will work closely with Principal Investigators, Departments and Sponsors in coordinating the registration and updates of investigator initiated trials, and will also be available to assist Principal Investigators in obtaining Sponsor registration for non-investigator initiated trials.
Questions concerning ClinicalTrials.gov or the registration process may be directed to Brian Prindle, Associate Director of Research, RGP/DSR. (top)