- Published
- Updated
A corrected value in a source system may remain wrong in previously delivered research copies. Making a correction and applying it to every affected output are separate questions that need different acceptance evidence.
Preserve the meaning of data
Create links showing which deliveries, reports and assessments a correction affects. Reviewers need to understand where the previous value was used as well as what the current value is. Preserve correction authority, rationale and acceptance timing. When receivers update at different frequencies, define how temporary discrepancies are displayed and who reconciles them.
Worked example
For example, a laboratory corrects the specimen identifier associated with a result. EDC receives the revised link, while a central-review report still uses the earlier association. Data management links the correction identifier to both outputs, identifies reports needing regeneration, and alerts the relevant team to review any open decisions based on the earlier report.
Review checks
- Trace a selected correction through every relevant interface.
- Check version information that prevents obsolete reports appearing current.
- Distinguish successful sending from receiver acceptance and application.
Acceptance and boundaries
Acceptance means the status of affected receivers is explainable and outstanding differences have accountable owners. Not every change has the same clinical importance; relevant experts should assess that impact. Successful technical propagation does not automatically reapprove a historical decision. Preserve the relationship between the updated output and its preceding version so later review can reconstruct the sequence.
Frequently asked questions
- Is a sent status sufficient?
- No. Evidence should also show that the receiver accepted the correction and applied it to the intended record.
- Should earlier reports be deleted?
- Apply the approved version-control arrangements rather than silently removing evidence of earlier use.