Registration of Clinical Trials

Clinical Trial Registration

REGISTRATION OF CLINICAL TRIALS

The International Committee of Medical Journal Editors (ICMJE) requires, as a condition of publication, that all clinical trials be entered into a public registry before enrolling the first patient. The intent 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."

Lifespan has selected ClinicalTrials.gov (link) to provide that vehicle. We have registered as an organization through which Lifespan Investigators may register their clinical studies.

Responsibility for registering trials for publication consideration lies with the lead sponsor of the clinical study; consequently, most industry-sponsored studies will be registered by the sponsor. Lifespan investigator-initiated studies and those for which the institution holds the IND or IDE that meet the criteria will need to be registered prior to study enrollment.

Registration Criteria. ICMJE guidelines establish the following criteria for clinical study registration:

•  Any research project that prospectively assigns human
subjects intervention and comparison groups to study the
cause and effect relationship between a medical
intervention and a health outcome.

•  Trials with at least one prospectively assigned
concurrent control comparison group.

•  Any trials whose primary purpose is to affect clinical
practice (Phase 3 Trials.)

Exclusions to Registration. ICMJE guidelines specifically exclude from the registration requirement studies conducted for other purposes including pharmacokinetics or major toxicity (Phase I Trials).

Registration Timeline.

•  New trials, started on or after July 1, 2005 (registration
required before enrollment of first patient)

•  Ongoing trials, by September 13, 2005.

Steps for Registering Clinical Studies. The registration system allows users at the investigator or study coordinator level to input the registration data; however, user access is provided centrally.

Contact Leslie Varone, Protocol Registration System
(PRS) Administrator at .

•  Request account setup for PRS users to , provide user ID
that you would like the PRS to use, full user name, and email address and your Lifespan Affiliate (RIH, TMH, Brad).

•  When user has received email notification of account
activation, access the PRS website at
http://register.clinicaltrials.gov

•  Log on and change password

•  Go to Main Menu, then Protocol Records, select create,
and follow the prompts.

•  Carefully respond to data elements requested; note that
fields marked with an * are required; fields marked WHO
should also be entered.

Further Information on ICMJE Initiative:

Is This Clinical Trial Fully Registered? (May 2005) Update on Clinical Trials Registration (October 2004) Clinical Trial Registration (September 2004)