How-Tos

Determine if Your Trial Needs to Be Registered on Clinicaltrials.gov

Which trials are required to be registered by law?
The law states that an applicable clinical trial generally includes

(1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I 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.

Any trial that meets the definition of an applicable clinical trial that was not completed prior to September 2007 must be registered. The completion date is the date when the data collection was complete.

What is Washington University’s policy?
Washington University policy requires registration of those trials that are mandated by the regulations. The University encourages investigators to consider the ICMJE policy regarding publication when making decisions about trials where registration is not mandated by regulation.

What is the policy of the International Council of Medical Journal Editors (ICJME)?
The International Council of Medical Journal Editors (ICJME) will require, as a condition of consideration for publication in their journals, registration in a public trials registry. A list of member journals can be found at: http://www.icmje.org/journals-following-the-icmje-recommendations/.

The ICJME defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.

Download the ICMJE Decision Flowchart (PDF)

What is the policy of the Food & Drug Administration
Below is a decision tree to help you determine how your trial should be registered in accordance with FDA Amendments Act of 2007.

Download the FDA Decision Flowchart (PDF)