Overview
Record Owners are expected to update their records within 30 days of a change to Overall Recruitment Status or Completion Dates and at least once every 12 months.
Requirements for Maintaining Study Records
Updates
Record Owners are required to update their records within 30 days of becoming aware of a change to any of the following:
- Study start date, Intervention name(s), Availability of Expanded Access, Expanded Access status/type, Overall recruitment status, Individual site status, IRB review status, Primary Completion Date, Study Completion Date, Responsible Party, Official Title, Contact Info.
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Device product not approved or cleared by the FDA (change in approval or clearance status)
Annual Review
Record Owners are required to update or verify the accuracy of their record(s) at least once every 12 months.
Status Changes
Upon change in status to ‘Active, Not Recruiting’ and/or ‘Completed’ all ‘Anticipated’ enrollment numbers must be changed to ‘Actual’ enrollment numbers in the ‘Study Design’ section of the record.
For NIH-Funded Studies
Upon Actual Study Completion Date (last participant's last study visit), a blank informed consent form (ICF) that was used to enroll participants must be uploaded to the ClinicalTrials.gov record no later than 60 days after the last study visit by any participant to satisfy the Revised Common Rule requirement.
How to Update a Study Record
Please see PRS' Updating a Study Record Guided Tutorial for assistance with complying with maintenance requirements.