Registration of Clinical Research Trials on ClinicalTrials.gov
The purpose of clinical trial registration is to promote the public good by ensuring that the existence, design and results of both ongoing and closed clinical trials are publicly available. Since November 1997, the FDA has mandated registration of clinical trials for serious or life-threatening diseases and conditions on the ClinicalTrials.gov Web registry. More recently, on September 27, 2007, new legislation was enacted expanding the scope of clinical trials that must be registered.
What are the consequences for failing to register applicable trials?
- Penalties for failing to register trials are significant and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.
- The International Committee of Medical Journal Editors (ICMJE) journals, such as JAMA, NEJM and Pediatrics, will not publish any articles on research initiated after July 1, 2005, that were not listed with ClinicalTrials.gov prior to patient enrollment. If a trial was ongoing as of July 1, 2005, ICMJE will accept articles for review, as long as the trial is registered prior to submission.
Which trials must be registered?
Download this explanatory flowchart (VSD).
Who is responsible for registering clinical trials?
- The sponsor of the clinical trial
- Usually the clinical trial will be registered by the sponsor. NIH-sponsored trials should be registered by the institute that is funding the research. Industry-sponsored trials (industry-written protocols) should be registered by the industry sponsor. Multi-site trials should be coordinated among the sites and registered by the “lead sponsor” so that ClinicalTrials.gov does not receive multiple registrations for the same trial.
- The principal investigator (PI) of the clinical trial
- Investigator-initiated trials (for which industry has supplied drug or grant funds) should be registered by the PI. Trials for which PIs hold their own INDs or IDEs should be registered by the PI. Additionally, trials that the sponsor has declined to register should be registered by the PI. PIs should always verify the completion and accuracy of a sponsor’s registration by looking at the ClinicalTrials.gov listing.
What is the process for registering a trial?
Guidance for registering a trial is provided to ClinicalTrials.gov user account holders on the ClinicalTrials.gov Protocol Registration System (PRS).
If you do not have a Seattle Children’s ClinicalTrials.gov user account, or if you have any questions, please email Research Help.