Editing and updating a record
This page describes the overall process of editing a study record. If you would like step-by-step instructions for entering registration or results information into the PRS, see the PRS User’s Guide.
At any time, you can make updates and edits to records published on BMU CTR by signing in to the BMU CTR PRS. You have the option of editing all record modules at once, or individual modules. For detailed information about editing records, please see Section 7: Updating and maintaining records in the PRS User’s Guide.
After you finish making changes, the record goes back through the same steps as a new registration: mark it Entry Completed, have the Responsible Party approve it, and release (submit) it to BMU CTR for quality-control review. The published version stays on BMU CTR until the changes pass review; they are then published as a new version of the record. See the BMU CTR Protocol Review Criteria for a description of items that should be addressed before releasing the record to BMU CTR. See the BMU CTR protocol information review process for more information.
Required registration updates
Responsible Parties should update their records within 30 days of a change to any of the following:
- Recruitment Status and Overall Recruitment Status data elements on BMU CTR
- Completion Date (See Primary Completion Date data element on BMU CTR)
Other changes or updates to the record, such as protocol amendments, should be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.
Submitting results
When your study has results, the Responsible Party can enter summary results in the PRS and submit them for quality-control review. See How to Submit Your Results and Clinical Trial Reporting Requirements for more information.
View earlier versions of your study record
The most recent version of a study record is displayed on BMU CTR. Every published version of a study record is available in the History of changes section of the study record.