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Office of Research Compliance


Clinical Trials Registration

It is the policy of the University of South Carolina that clinical trials are registered in a manner that is consistent with  federal agency requirements.. Specifically, trials must be registered in a database called ClinicalTrials.gov when they begin. the record must be updated throughout the study with results provided when the study ends. Significant penalties can be applied by the agencies if these requirements are not met – including loss of an investigator’s ongoing or pending grant funding.

Definition of a Clinicial Trial

  1. The U.S. National Institutes of Health (NIH) defines a clinical trial as: "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.”
  1. The FDA defines an Applicable Clinical Trial (ACT) as follows:
  1. The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”

When to Register and Report

  ICMJE FDAAA and HHS RULE NIH
When to Register the Trial Prior to enrollment of first subject Within 21 days of enrollment of first subject Within 21 days of enrollment of first subject
When to Report Results Not applicable Within 12 months of final data collection for primary outcome Within 12 months of final data collection for primary outcome

 

PI Responsibilities

The PI can delegate the responsibility for entering the information required for registration, updates, and results reporting – but the PI remains responsible for:

  • The accuracy and completeness of the information
  • The Approve and Release actions that are required each time information is entered into the trial record
  • Obtaining an account with the PRS data entry system used by ClinicalTrials.gov, so that s/he can log into the system for the Approval and Release actions

An extensive amount of detailed information is required. The time and knowledge necessary to create a record (register) and to enter results should not be under-estimated

Consent Form Requirements

Regulations require a statement in the consent form(s), without revision. The required language is already included in the  USC informed consent form template.

Consequences and Penalites

Federal agency penalties for non-compliance were generally not enforced prior to January 18, 2017. However, the expanded requirements implemented on this date include additional possible penalties and a declaration of intent to enforce the penalties. The range of possible agency actions is summarized below.

FDA-regulated research

  • Civil monetary penalties for the responsible party of $10,000 (initial) and $10,000/day for duration of the uncorrected non-compliance
  • Public notice of non-compliance at ClinicalTrials.gov
  • HHS agencies (e.g., NIH) may withhold continuing funds for existing grants, and/or awards of new funding to the PI
  • HHS research funding to the entire institution could be withheld

NIH-sponsored research

  • Public notice of noncompliance at ClinicalTrials.gov
  • HHS agencies (e.g., NIH) may withhold continuing funds for existing grants and/or awards of new funding to the PI
  • HHS research funding to the entire institution could be withheld

Medicare
Claims will not be paid

International Committee of Medical Journal Editors
Inability to publish in prominent medical journals

Office of Research Compliance
USC IRB approval will not be renewed unless a trial has been registered

Office of Research Compliance