Maintained by the National Library of Medicine (NLM) at the National Institutes Of Health (NIH), the clinicaltrials.gov website provides the public with access to information on publicly and privately funded clinical research studies. Federal law, some journal publication standards, and some funders require registration of clinical trials and even some clinical studies on clinicaltrials.gov.
Why register with clinicaltrials.gov?
Besides avoiding the potential loss of NIH funding, federally imposed penalties of $12,103 per day, and inability to publish, investigator compliance with clinicaltrials.gov promotes research transparency and scientific integrity. By posting results from all trials, not just published findings, investigators provide guidance for future research and augment the existing evidence base.
Do I need to register my study?
If the study involves human participants prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes AND was initiated or completed on or after January 18, 2017, you likely will have to register.
If you want to publish the research in a medical journal, you will likely have to register
The International Committee of Medical Journal Editors (ICMJE) sets the publishing guidelines for most medical journals and requires studies to be registered with clinicaltrials.gov PRIOR to enrolling subjects.
If you are unsure about registration, please contact Greg Kelley
I will have to register the study, what is the next step?
The CTU is here to assist all Tulane University School of Medicine investigators navigating the registration and results reporting process. Click here for an overview guide on working with clinicaltrials.gov.
The first step in registering your study is to apply for a Protocol Registration System (PRS) account on clinicaltrials.gov. Click here for directions on how to create a PRS account.
I now have a PRS account and am ready to register the study.
Excellent! Click here for directions on the registration process.
I am currently registered with clinicaltrials.gov, what is the next step?
Here’s a quick overview on how to keep your study registration up-to-date:
When do I report results?
Do I need to post an informed consent form?
If the clinical trial began or ended on or after January 21, 2019, then read below.
How can the CTU assist me?
Support for Tulane University School of Medicine investigators is provided free of charge through the Clinical Translational Unit (CTU)
Please direct all clinicaltrials.gov questions to: