ORI HOT TOPIC

Clinical Trial Registration Advice

Scope:
This memorandum provides guidance to Northwestern University (NU) Principal Investigators (PIs) and researchers regarding the advantages to registering all IRB approved "clinical trials" at , before beginning subject enrollment. Under the governing regulations, "clinical trial" is defined as: "Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome" (JAMA 2005; 293:2927-2929). Medical intervention means "any intervention used to modify a health outcome, including drugs, surgical procedures, devices, behavioral treatments, process of care changes and the like."

Introduction:
The NIH, in collaboration with the FDA, developed clinicaltrials.gov to create a central, public resource for people with serious or life-threatening diseases, with current information on federally and privately funded clinical trials. This is one of several initiatives that are a result of the FDA Modernization Act of 1997 (FDAMA 113) and a decision by the International Committee of Medical Journal Editors (ICJME) to require public registry before the onset of patient enrollment, as a condition of consideration for publication, http://prsinfo.clinicaltrials.gov/icmje.html. The NU Office for Research has registered Northwestern University as a research Institution. Each individual researcher should register his/her clinical trial(s) at http://prsinfo.clinicaltrials.gov in order to comply with the ICJME decision. The registration process is explained on the website. It is straightforward, and should take no more than 15-20 minutes. Researchers are encouraged to work closely with sponsors, to ensure that the trial is registered in a timely fashion and that care is taken to avoid duplicate registrations in multi-site and multi-sponsor studies. The clinical trial listing does not need IRB approval. Therefore, neither the initial registration nor any updates made to the study's registration information online will be reviewed by the IRB (www.hhs.gov/ohrp/policy/clinicaltrials.html).

What NU researchers should do:
  • New projects: Before a researcher begins enrolling subjects, he/she is encouraged to register an IRB approved trial at http://prsinfo.clinicaltrials.gov.
  • Current, ongoing projects: Regardless of the current stage of activity, (periodic review, open enrollment, closed to accrual, etc)1 all ongoing projects should be registered as soon as possible at http://prsinfo.clinicaltrials.gov.
  • Future, ongoing projects: In addition to initial registration, data should be updated during the course of the trial. Once again, researchers are encouraged to work closely with sponsors to avoid duplication of efforts.
Researchers who have not registered their trials take the risk of not having their manuscripts reviewed and/or accepted by medical journals.

What the NU Office for Research is doing to help:
The Office for the Protection of Research Subjects (OPRS) will include a statement in New Project approval letters reminding researchers to register before enrolling any subjects on the trial. A corresponding statement will also be included by OPRS in the approval letters for Periodic Reviews, reminding researchers to visit the clinicaltrials.gov website to update the study's registration information.

For additional information, please access the following resources:

1 Although the definition of a clinical trial excludes Phase I and early Phase II studies, the NIH registry service calls for all clinical studies from Phase I through post-marketing Phase IV trials, including studies of new indications for an approved product. 		Feature
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