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ClinicalTrials.gov

Registering Your Research on ClinicalTrials.gov

Clinicaltrials.gov is a public registry of clinical trials maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The website is designed to provide patients, healthcare professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials on a wide range of diseases and conditions. The Protocol Registration and Results System (PRS) is a web-based tool developed for submitting clinical trial information to ClinicalTrials.gov.

Why Register Clinical Trials? 
  • Commitment to research participants
  • Scientific integrity
  • Ethical standards
  • Responsible stewardship of federal funds
  • Required by law (FDAAA)
  • Required by NIH (for NIH-funded research; whole and part)
  • Required for journal publication (ICMJE)

Resources

ClinicalTrials.gov

Register Your Study

Request an Account

PRS user accounts are managed through the HRPP/IRB Office. Email your account request to irb@ouhsc.edu or call us at 405-271-2045. 

Additional Information & FAQs About ClinicalTrials.gov Registration

Who is Responsible for Registering Trials and Submitting Results?

The "Responsible Party" for a clinical trial must register the trial and submit results information. 

The Responsible Party is defined as:

  • Sponsor: The entity that initiates the study (e.g., corporation or entity)
  • Principal Investigator: The individual designated as the Responsible Party by the sponsor, assuming:
    • The PI is responsible for conducting the trial;
    • Has access to and control over the data from the clinical trial;
    • Has the right to publish the results of the trial; and 
    • Has the ability to meet all of FDAAA's requirements for the submission of clinical trial information. 
  • Sponsor-Investigator: The individual who both initiates and conducts the study. 

Which Trials Should be Registered on ClinicalTrials.gov?

Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR 11) and FDAAA 801:

Trials that meet the definition of applicable clinical trial (ACT) must register on ClinicalTrials.gov. Use the checklist below to determine if your study is an ACT. Additional considerations are elaborated on in the full ACT checklist at https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf. Exceptions noted in the full checklist will be evaluated by OUHSC PRS administrators and IRB, who will inform investigators when they apply. 

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NIH and Publication Requirements for Registering on ClinicalTrials.gov

The NIH policy for Dissemination of NIH-funded Clinical Trial Information states that all NIH-funded clinical trials* must register and report results, regardless of:

  • the study phase
  • type of intervention 
  • whether or not the trial is an "applicable clinical trial" subject to FDAAA 
NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 
 
This definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and studies of any intervention not regulated by the FDA, such as behavioral interventions. 
 
More information and resources are available on the NIH website at: https://grants.nih.gov/policy/clinical-trials/reporting/understanding.htm 
 
 
Publication Registration Requirements - International Committee of Medical Journal Editors (ICMJE)
Journals registered with ICMJE require:
  • Registration of clinical trials in a public registry (ClinicalTrials.gov) at or before enrollment of the first participant.
  • Registration is a condition for publication of research results.
  • ICMJE encourages posting clinical trials results in ClinicalTrials.gov, but it is not required. (This does not overrule federal requirements or NIH policy requirements to register and report results when applicable to the research study/trial.)
Investigators are strongly urged to contact their journal or publication source to verify whether or not registration on ClinicalTrials.gov is required as a condition to publish. 
 

When Should I Register My Study on ClinicalTrials.gov?

The table below will illustrate the timeline for registering on ClinicalTrials.gov and whether or not posting of results is required.

 

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Are There Penalties if I Fail to Register or Submit Results?

Yes. FDAAA and NIH have posted penalties for failure to comply with regulations and policies.

FDA Penalty (as of 7/22/2022): The adjusted penalty that may be assessed for failure to comply with ClinicalTrials.gov registration and reporting results requirements is $13,237. 

  • Additional $13,237 may be assessed per study, per day until noncompliance is resolved if unresolved after 30 days. 
 
NIH Penalty: Noncompliance with NIH policy (for NIH-funded research) may lead to suspension or termination of award; and a history of noncompliance can impact access to future funding. 

Where and How Do I Register My Trial on ClinicalTrials.gov?

The Protocol Registration and Results System (PRS) is located at register.clinicaltrials.gov. 

New users must request an account from the University's PRS Administrator by sending an email to IRB@ouhsc.edu. 

Additional instructions for how to register a trial can be found here: https://clinicaltrials.gov/ct2/manage-recs/how-register

 

How Do I Gain Access to a Study That's Already Registered?

The person listed as the "Record Owner" for a study can add you to the Access List located on the Record Summary page if you already have an account.

If you do not have an account or the Record Owner is no longer with your department or the University, please contact the IRB Office for assistance (irb@ouhsc.edu or 405-271-2045).