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Clinical Trials

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.


What are the clinical trials reporting requirements?

The FDA Amendments Act of 2007 (US Public Law 110-85, Sec. 801) contains requirements related to clinical trials registration and results reporting, to be phased in over several years. First, applicable clinical trails (as defined below) were required to be registered effective 2007. Second, effective September 2008, results of applicable clinical trials must be posted within 12 months of the completion date (final subject visit). In September 2009, adverse event reporting will be implemented.


What results must be reported?

Basic results for applicable drug and device trials must be reported, including demographic and baseline characteristics of the patient sample, primary and secondary outcomes, a point of contact and certain agreements that restrict discussion or publication of results.

Results of clinical trials that are registered in order to meet the ICMJE publication requirements, but otherwise do not meet the FDA applicable clinical trial definition, do not have to be posted on clinicaltrials.gov.


What is clinicaltrials.gov?

A widely used clinical trials 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, updated by the FDA Amendments Act of 2007. The registry has been endorsed by organizations including the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), and the Association of American Medical Colleges (AAMC).


How do I get a login?

Clinicaltrials.gov delegates logons and initial review of clinical trials to a designated administrator. University of Missouri faculty or staff who wish to obtain a logon or get help in registering a clinical trial should contact Laura Wright at 882-3654 or Susan Koenig at 882-2460.


Who must register the clinical trial?

Sponsors of multi-site studies are responsible for one-time registration for all sites. Sponsors typically include information about individual sites in the clinical trials listing after the site has been initiated into the study.

The investigator who is responsible for conducting an internally sponsored clinical trial is responsible for registration.


What is an NCT number and how do I get one?

The NCT number is a unique number assigned by clinicaltrials.gov to each clinical trial that has been submitted for posting.


What is the PRS?

The PRS, Protocol Registration System, is the name of the clinicaltrials.gov web-based registration system.


Which studies must be registered?

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.


What is the FDA definition of an applicable clinical trial?

The FDA definition of an applicable 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.


What is the ICMJE definition of a clinical trial?

The International Committee of Medical Journal Editors (ICMJE) has expanded the definition of a clinical trial to include “the WHO (World Health Organization) definition of a clinical trial: “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.”


Related Information

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 clinicaltrials.gov, email: koenigse@health.missouri.edu























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