ClinicalTrials.gov Registration

Definition

• ClinicalTrials.gov is a web-based resource that provides the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Policies/guidelines

• The responsible party must register all applicable clinical trials (ACT) on clinicaltrials.gov, update the status of the trial on the website, and report results. 
  • Typically, the study sponsor is considered the responsible party, unless the sponsor designates that responsibility to an investigator.
  • ClinicalTrials.gov (external site) has published a checklist for evaluating whether a clinical trial is an ACT. - External site
• Requirements from Section 801 of the Food and Drug Administration Amendments Act:
  • Register the ACT on ClinicalTrials.gov no later than 21 days after enrollment of the first participant.
  • Update the ACT on ClinicalTrials.gov at least once every 12 months. Note that some items require update within 15 or 30 days of change (e.g. recruitment status, primary completion date).
  • Submit summary results (including adverse event information) no later than 1 year after the ACT’s primary completion Date.
• To register your clinical trial:
  • Request an account by emailing clinicaltrials@umc.edu and provide the IRB number.
  • Log-in to ClinicalTrials.gov.
  • Enter the required and optional data elements.
  • Preview, inspect, and submit the record.
• Penalties for noncompliance include withholding of National Institutes of Health (NIH) grant funding and civil monetary penalties of up to $10,000 a day. Additionally, in order to consider the study for publication, the International Committee of Medical Journal Editors (ICJME) requires all clinical trials to be reported to the site prior to enrollment.
• Questions regarding clincialtrials.gov requirements can be submitted to Yolanda Griffin, manager of the Office of Clinical Trials Regulatory Affairs.

Training

• ClinicalTrials.gov training material - External site