Clinical Trial Website Registration Requirements

Information on ClinicalTrials.gov

Clinical trial registration is required by both the Food and Drug Administration Amendments Act (FDAAA) and International Committee of Medical Journal Editors (ICMJE). Meeting FDAAA requirements satisfies federal regulations. Meeting ICMJE requirements satisfies many journals’ publishing requirements. Registering your study on clinicaltrials.gov satisfies FDA and ICMJE requirements for making trial information available to the public. Registering a study is only the first step. There are additional requirements over the life of the study. ICMJE requirements include a broader range of studies that need to be registered. Pay close attention to the key points listed in the table below to determine if your trial needs to be registered. Contact Kevin Smilor (ksmilor@kumc.edu) at the CRA if you:

  1. Need help determining if your trial needs to be registered
  2. Need help determining if you are the person responsible for the registration (are you the IND/IDE holder? Are you the Grant awardee? Did you initiate the study? Are you the PI who is responsible for conducting the trial AND has control over data AND has rights to publish results?)
  3. Have any other questions about registering your study on clinicaltrials.gov.

Trial Registration Key Points by Authority1

ICMJE

FDAAA

Which trials must be registered?

Interventional Studies:
ALL phases
AND;
ALL intervention types

Interventional studies:
NOT phase 1 or small feasibility trials
AND;
Trials that involve a Drug, Device or Biologic

When to register the trial?

PRIOR to enrollment of first subject

Within 21 days of enrollment of first subject

Where should it be registered?

Clinicaltrials.gov OR WHO primary registry

Clinicaltrials.gov

When to report results?

Not Applicable

Within 12 months of final data collection for the primary outcome

1Table adapted from a presentation: n.p. (October 2012) Overview of FDAAA and Other Trial Registration Policies: Results Database Train-the-Trainer Workshop [PowerPoint slides]


If you have a study that has not been registered on clinicaltrials.gov, or think you have one that needs to be registered, contact Kevin Smilor (ksmilor@kumc.edu) at the CRA for assistance. The CRA can help with:

  1. Initial clinical trial registration
  2. Creation of clinicaltrials.gov accounts (DO NOT request an account directly from clinicaltrials.gov)
  3. Ongoing management of clinical trial registrations (updates are required at different time points)
  4. Registration of adverse events and study results (if required)

Additonal information about registering clinical trials: 

Last modified: Apr 17, 2015
ID=x3335