Clinical Trials Registration

There is some confusion regarding registration of clinical trials. One reason for this confusion is the fact that there are at least two different recent sets of clinical trial registration requirements that may be relevant to you as an investigator. The FDA and the International Committee of Medical Journal Editors (ICMJE) each have their own registration requirements. While some of the requirements overlap, there are also significant differences. In order to comply with new laws and preserve the ability to publish in ICMJE journals both sets of requirements must be met.


FDA Clinical Trials Registration:

The 1997 FDA Modernization Act (FDAMA) required the registration of trials testing drugs for life threatening diseases and conditions. This requirement led to the creation of ClinicalTrials.gov which is administrated by the National Library of Medicine.

What has changed with the FDA Registration?
In September 2007, the FDA Amendment Act expanded the current ClinicalTrials.gov requirements.

  • It expands the types of trials that must be registered to all clinical trials for drugs, devices, and biologics with the exception of Phase I drug trials and small device feasibility studies.
  • Remember that the previous required registration was limited to drug trials for life-threatening diseases or conditions..
  • It increases the data elements that must be included in the registration
  • Within three years, the results of trials must be registered upon the completion of the primary aim of the study. The logistics for the registration of results have not yet been developed.


ICMJE Clinical Trials Registration:

On June 9, 2005, the International Committee of Journal Medical Editors (ICMJE)* made registration of phase 2 and beyond clinical trials a condition for publication in any of their journals. Their definition of clinical trial is:

  • Any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome
  • Note: A medical intervention could be a procedure, including talk therapy or other similar psychiatric interventions.

    * ICMJE Signatories: New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croation Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association.

What has changed with the ICJME Registration?
Effective July 1, 2008. the ICMJE is requiring the registration of all clinical trials including Phase I and pharmaco-kinetic trials.


Updating Registrations:
Once a trial is registered, both the FDA and the ICMJE require that registrations be updated as follows:

FDA updating requirements:

  • Information must be updated at least every 12 months
  • Additionally the registry must be updated within 30 days of any changes in recruitment status or completion of study

ICMJE requires updating study information every six months

Who is responsible for registration?
For FDA Registration:
The sponsor of the drug or device clinical trial, as defined/identified under the FDA regulations, is responsible for registering the trial. This could be either the company or the investigator.

If the sponsor is the company, the company at its discretion, can delegate the principal investigator as the “responsible party.” This may only be done when “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.

For ICMJE Registration:
While anyone involved in the clinical trial could register the trial, in practice this responsibility usually falls with the individual submitting the publication to the ICMJE journal, which is usually the Principal Investigator.


What is the deadline for registration?

N.b., Compliance with the ICMJE is only required if publication in one of the relevant journals is planned. In contrast, compliance with the FDA regulations is required for relevant trials. If there is any possibility of submission to an ICMJE journal for publication, we suggest compliance with both registration requirements.

Compliance with the new FDA law of 2007 requires completing registration of the following by December 26, 2007.

Phase 2 and beyond drug/biologic and device trials that are initiated after 9/27/2007 or that are ongoing as of 12/26/2007 must be registered in full. This includes:

Registration of trials that have not previously been registered AND

Update of ongoing clinical trials that have previously been registered (Ongoing is defined as 1 or more subjects enrolled and the completion date has not been reached).

Registration for a new study is required within 21 days after enrolling the first subject (FDA)

Compliance with the ICMJE requires the following registration by July 1, 2008:
All phases of any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome.

Registration is required before the first subject is enrolled (ICMJE)


Registering your study:
You must work through our “institutional account”. Do not go directly to ClinicalTrials.gov, they will simply send you back to us.
To start this process, contact the PHRC registration administrator

Provide the Administrator with the following information:

Partners log-in ID [username only]
Full Name
Home Institution
Partners Email Address

The Administrator will enter this information into the ClinicalTrials.gov website
and thus create a “profile” for the Investigator. The ClinicalTrials.gov website sends confirmation to the investigator regarding his/her ability to sign onto the website and begin the registration process. For further details, see FAQs on Clinical Trial Registration.

The investigator can then enter the study registration information. An email will
be automatically sent to the Administrator, who will “release” the registration to
the website.

If ClinicalTrials.gov has any questions related to the study or information about
the study - their query will be sent directly to the investigator (or designee).

For questions call/contact:

Deb Barnard at 617-424-4171 or dbarnard@partners.org

Vicki Mirabello at 617-424-4140 or vmirabello@partners.org