Registration

How to Sign Up...

Clinical trials registration makes it possible for any member of the public, or any healthcare professional or potential investigator to search a web site and determine what is being studied and who to contact for information.

The most widely used registry is http://clinicaltrials.gov, a web site developed by the National Institutes of Health (NIH), through its National Library of Medicine (NLM), in collaboration with the Food and Drug Administration (FDA). The website is the result of the FDA Modernization Act passed in 1997, with significant updates in the FDA Amendments Act of 2007. Organizations including the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), and the Association of American Medical Colleges (AAMC) have endorsed the registry.

Clinicaltrials.gov delegates logons and initial review of clinical trials to a designated administrator at each University. The University of Missouri endorses registration on clinicaltrials.gov, and provides an administrator to assign logon accounts and work directly with clinicaltrials.gov to improve registration of studies that involve faculty members as principal or secondary investigators. University of Missouri faculty or staff who wish to obtain a logon or get help in registering a clinical trial should contact the UM administrator.

Studies that meet the FDA definition of a clinical trial must be registered. In addition, studies that meet the ICMJE definition must be registered if the investigator wishes to eventually publish.

Sponsors of multi-site studies are responsible for registration on clinicaltrials.gov. An individual site is added to the multi-site sponsor’s registration page after the site has been initiated for the study.

Investigators who have developed a protocol that meets the requirements for registration are responsible for registering the study on clinicaltrials.gov. The investigator obtains a logon and enters the study information on http://clinicaltrials.gov. This can be done in one or many sessions, and work is saved but not available for public view until the trial information has been completed by the investigator, released by the administrator, and posted by clinicaltrials.gov staff. The information remains in draft status until the investigator submits it as ‘complete.’ When the IRB approval number is obtained, the investigator will add it to the registration information. Clinicaltrials.gov assigns an NCT number to each clinical trial after it is completed and submitted for posting. The NCT number is a unique number assigned by clinicaltrials.gov to each clinical trial.

You can view the online Clinical Trials Sign-Up Form here.

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• What is the definition of a clinical trial?
• What are the requirements?
• Chronology of events
• View a Power Point presentation
• Useful links

What is the definition of a clinical trial?

The FDA definition:

The Food and Drug Administration requires registration of both federally- and privately-funded trials. The FDA definition of a clinical trial, revised in September 2007, includes (1) trials of drugs and biologics: controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) trials of devices: controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance.

The registry can accept non-qualifying trials as well, including interventional and observational studies.

The ICMJE definition:

The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.

What are the requirements?

The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), in collaboration with the Food and Drug Administration (FDA) has developed an on-line registration of clinical trials in order to provide information to patients, their families, the public and healthcare professionals. The registry, clinicatrials.gov, is a result of the FDA Modernization Act passed in 1997, with significant updates in the FDA Amendments Act of 2007.

Organizations including the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), and the Association of American Medical Colleges (AAMC) have endorsed the registry.

• FDA – What:
  The Food and Drug Administration requires registration of both federally- and privately-funded trials, including (1) trials of drugs and biologics: controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) trials of devices: controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance.

  The registry can accept non-qualifying trials as well, including interventional and observational trials.




• FDA – When:
  The FDA Amendments Act of 2007 requirements:
  1. Trials initiated after 9/27/2007, or trials that area ongoing as of 12/26/2007 must be registered in full by: The later of 12/26/2007 or 21 days after the first patient is enrolled.
  2. Trials that were “ongoing” as of 9/27/2007 and do not involved a “serious or life threatening disease or condition,” must be registered by 9/27/2008.
  3. Trials that were “ongoing” as of 9/27/2007, do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements.



• ICMJE – What:
  ICMJE defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.



• ICMJE – When:
  ICMJE policy requires registration in a WHO primary register (clinicaltrials.gov is a WHO primary register.) The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrollment on or after July 1, 2008. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.



• WHO – What:
  All medical studies that test treatments on human beings, including the earliest studies, should be registered and should include 20 specific data elements.



• WHO – When:
  Registration should occur before recruitment of the first participant.



• AAMC – What:
  The AAMC uses the ICMJE definition of a clinical trial to be listed on clinicaltrials.gov or other registry.



• AAMC – When:
  Registration would be required within 21 days of initiating enrollment of participants.

Chronology of Events

Please click here to view a chronology of events.

Powerpoint Presentation

Please click here to view a Power Point presentation.

Useful Links

To obtain a logon for clinical trials registration: koenigse@health.missouri.edu

• Search for a clinical trial: http://www.clinicaltrials.gov
• Register a trial: http://prsinfo.clinicaltrials.gov
• ICMJE web page: http://www.icmje.org
• ICMJE registration policy: http://www.icmje.org/
• AAMC Dec 2007 statement: http://www.aamc.org/advocacy/library/