Study Activation

Main Content

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