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Maintaining and Updating ClinicalTrial.gov Records
Due to the pause in face-to-face human subjects research during the COVID-19 pandemic, you may need to update the status of a clinical trial in ClinicalTrials.gov. Review the Updating ClinicalTrials.gov due to COVID-19 Pause guidance document from ORCR and UMMS Regulatory Affairs for details.
Required Updates to an Active ClinicalTrials.gov Record
In general, the Responsible Party must review and update, as necessary, an active study record at least annually. Failure to do so will result in the record being identified as having a problem that needs to be addressed.
Some updates must be made more frequently than annually. Specifically, the Responsible Party must update the registration record in ClinicalTrials.gov within 30 days of a change to the following:
- Overall Recruitment Status (for the entire study across all sites).
- Note, if at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting."
- Individual Site Status (i.e., the recruitment status of each participating facility in a multi-site clinical study).
- Primary Completion Date
- The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.
As a best practice, anytime you review or make a change to the record, update the record verification date to the current month and year before releasing it for review.
For questions related to ClinicalTrials.gov, contact:
- Medical School Units: Office of Regulatory Affairs (734) 764-0634 or Health Legal System Office at (734) 764-2178
- Campus Units: Office of Research Compliance Review (ORCR) at (734) 764-3628 or firstname.lastname@example.org