22 Registration of Clinical Trials

PDAD&C #22, 2005-06

MEMORANDUM

To: Principals, Deans, Academic Directors and Chairs
From: John R.G. Challis, Vice-President, Research and Associate Provost
Date: October 6, 2005
Re: Registration of Clinical Trials
_______________________________________________________________________________



As of September 13, 2005, it is now a requirement for publication of the International Committee of Medical Journal Editors that all clinical trials are registered prior to the commencement of the research activity.  All clinical trials that are ongoing, but have yet to be registered must do so immediately.

The definition of “clinical trial”, as established by the ICMJE is:

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.  By “medical intervention” we mean any intervention used to modify a health outcome.  This definition includes drugs, surgical procedures, devices, behavioural treatments, process-of-care changes, and the like… A trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.”

This definition may involve several research disciplines and faculties that would not typically self-identify as conducting “clinical trials”, including OISE, Nursing, Psychology, Public Health Sciences and the like.  It is therefore extremely important for all investigators conducting human subject research that intend to (or may possibly) publish in a journal within the scope of ICMJE to be aware of the requirements.        

It is the responsibility of the Principal Investigator to register all studies that qualify as clinical trials at www.clinicaltrials.gov or www.controlled-trials.com.  This must be done after REB approval, but prior to commencement of the research activity.  For multi-site studies, it is the responsibility of the sponsor of the primary site (where primary REB approval was sought) to register the study, in order to avoid duplication. 

Please contact Rachel Zand, Director, Ethics Review Office with any questions of the requirement or process at Rachel.zand@utoronto.ca, or 946-3389.