Ongoing Record Maintenance Requirements
The Principal Investigator is responsible for maintaining the accuracy of the registration record information in accordance with regulations. This includes information updates as applicable, no less than once every 12 months and within 30 calendar days of the occurrence of a significant change. Some examples of a “significant” change include: Study Start Date, Overall Recruitment Status, Human Subjects Protection Review Board Status, Primary Completion Date, and Principal Investigator change. For specific details, see Changes from Current Practice Described in the Final Rule (Table 3).
During each record update, the Record Verification date field should be revised to reflect the current Month/Year attesting to the record’s accuracy. If no changes are needed at the time of the required annual update, the Record Verification field should be updated regardless and the record re-released for public update.
The obligation to submit updates and corrections ends on the date that all required data elements have been submitted for all primary and secondary outcomes and all adverse events collected in accordance with the protocol, and the QC process has concluded.
If you have any questions about these requirements or need help registering or reporting results for your clinical trial, please contact: