Clinical Trials Registry

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007. Under this law, the registry requirements for clinical trials in the United States was greatly expanded. The new law requires that all ‘applicable’ drug and device trials are to be registered with ClinicalTrials.gov, a database supported by the National Institutes of Health.

Applicable drug trial: All drug trials, except for Phase I studies

Applicable device trial: All device trials, except for feasibility studies

As of 2005, the International Committee for Medical Journal Editors (ICMJE) requires that applicable clinical trials be registered in a national registry in order for publication. There is a list of journals that are requiring registration and can be found at the following website: www.icmje.org
Please note: this is not an all inclusive list, so check with the journal intended for publication to see if registration is required.

In order to comply with the law, all applicable clinical trials must be registered on ClinicalTrials.gov no later than 21 days after the first subject is enrolled. However, some journals require that a study be registered prior to the first subject being enrolled or a manuscript will not be accepted. Please check with your journal to see if this more stringent rule applies.

For help registering your trial or any questions/concerns, please contact the following:

• UAMS Employees:  contact Tracy Gatlin TLGatlin@uams.edu at 686-6803

• ACHRI Employees: contact Margie Brackeen BrackeenMargieI@uams.edu at 364-3586 or Tanda Grisham GrishamTandaR@uams.edu

• CAVHS Employees: contact Robin Atkins RAtkins@uams.edu 257-5554.

Helpful Links:

• www.clinicaltrial.gov

• www.icmje.org