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Prospective Clinical Trials Involving the Consent Process: Public Registration of Research Studies

Public Registration of Research Studies

All research studies that meet the definition of a clinical trial must be registered at www.clinicaltrials.gov as per the International Committee of Medical Journal Editors (ICJME), US Public Law 110-85 (FDAAA).

  • A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes.  This includes Phase 1 Trials
  • Health related interventions include any interventions used to modify a biomedical or health related outcome (e.g. drugs, surgical procedures, devices, behavioral treatment, dietary interventions, and process-of-care changes)
  • Health outcomes include any biomedical or health-related measure obtained in patients or participants, including pharmacokinetic measures and adverse events.

Generally pharmaceutically sponsored studies are registered by the sponsor and grant sponsored studies are registered by the grantee.  It is best to check with the sponsor to ensure the trial has been registered.  If you are a PI and hold the IDE or IND you are responsible for registering your study.  Please contact Karen Christianson at 4-5714 to begin the process.  Once your study is registered you are required to update the study every 6 months at www.clinicaltrials.gov  

Place the initial registration and all update receipts in this section.

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