Clinical Trial Website Registration Requirements

Registration Requirements

Effective July 1, 2005, the International Committee of Medical Journal Editors (ICMJE) will consider a trial for publication only if it has been registered before the enrollment of the first patient.

The International Committee of Medical Journal Editors (ICMJE) is an international group of medical journal editors that has been setting publication guidelines for the submission of manuscripts to medical journals since 1978.

Current:
New Trials:  Before enrollment of the first patient

Important Update:

Due to Food and Drug Administration Amendments Act of 2007 (H.R. 3580), the requirements for posting, maintaining and reporting clinical trials have changed.

Click here for a full text copy of the FDA Amendments Act of 2007

CLICK HERE TO COMPLETE THE FORM TO POST A TRIAL

What you need to know about posting clinical trials:

What Clinical Studies Require Posting to www.ClinicalTrials.gov (PDF)

Clinical Trials.gov Fact Sheet - General Information on Posting Trials (PDF)

Federal Food, Drug and Cosmetic Act - Original Legislation

Quick Reference Posting Guide (PDF)
Clinical Trial Website Registration (ICMJE) Q & A sheet (PDF)