ClinicalTrials.gov

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 (PI): 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.

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

Trials that meet the definition of "applicable clinical trial" (ACT) must register on the site.

Criteria of an ACT includes:

• Intervention trials; and
• Phase 2 or higher FDA-regulated drug trials; and 
• Controlled trials with health outcomes of FDA-regulated devices (and pediatric post-market surveillance); and 
• Includes one or more arms of FDA-regulated drugs, biologics or devices that meets certain criteria

Click here to access a checklist to determine whether your trial meets the definition of an ACT which requires registration and reporting of results.

NIH Policy:

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 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, e.g., behavioral interventions.

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.

Researchers are strongly urged to contact their journal or publication source to verify whether or not registration on ClinicalTrials.gov is required in order to publish results.

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

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

11/6/2019 UPDATE - FDA Penalty: The Annual Civil Monetary Penalties Inflation Adjustment was released, effective 11/5/2019. The new penalty that may be assessed for failure to comply with ClinicalTrials.gov registration and reporting results requirements is $12,103. 

• If the noncompliance is not resolved within 30 days of notification, a penalty of $12,103 may be assessed per day until the violation (noncompliance) is resolved. 

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:  clinicaltrials.gov/ct2/manage-recs/how-register

The person listed as the "Record Owner" for the 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 HRPP office for assistance. 

Not always.

• The Primary Completion Date (PCD) is defined as, "the date the final participant was examined or received an intervention for the purposes of final data collection for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated."
   
• The Study Completion Date (SCD) is defined as, "the date the final participant was examined or received an intervention for the purposes of final data collection for the primary and secondary outcome measures and adverse events, whether the clinical study concluded according to the pre-specified protocol or was terminated.

Please contact the University's PRS Administrator in the HRPP for more assistance or guidance on how to determine the correct anticipated PCD and SCD for your study.