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How to Edit Your Study Record
Editing and Updating a Record
At any time, you may make updates and edits to a record published on ClinicalTrials.gov by logging into the Protocol Registration System (PRS) and clicking on "Modify" under the Protocol Records heading in the PRS main menu. After you finish making changes, you will need to re-release (resubmit) the record to ClinicalTrials.gov for review and processing. See the ClinicalTrials.gov Protocol Review Criteria (PDF) document for a description of items that should be addressed before releasing the record to ClinicalTrials.gov. See also information on the ClinicalTrials.gov Protocol Information Review Process.
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
- Completion Date (Primary Completion Date data element in ClinicalTrials.gov)
Other changes to the protocol or updates to the record must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months, even if there were no changes to the record, for studies that are not yet completed.
Submitting Results
For certain trials subject to Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Responsible Parties must submit summary results no later than 12 months after the date of final data collection for the prespecified primary outcome measure (Primary Completion Date data element in ClinicalTrials.gov). See How to Submit Your Results and FDAAA 801 Requirements.
View Earlier Versions of Your Study Record
The most recent version of a study record is displayed on ClinicalTrials.gov. A history of changes made to study records previously displayed on ClinicalTrials.gov is available on the archive site. You will need the NCT Number for the record in order to view its history. The NCT Number can be found at the top of every record. You can also click on the "History of Changes" link at the top of a record to see its archived versions.
