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- Published
- Updated
A concomitant treatment mentioned in a safety narrative may have different dates or status in a clinical table. The difference is not always an error: initiation, interruption and dose change may be represented differently. Reconciliation should explain the sequence in a way that supports appropriate clinical interpretation.
Scope of the decision
The review does not recommend treatment or decide causality. Compare medicine identity, use period and changes against authorised sources. Recognise different representations such as brand and active-substance names. Avoid silently resolving uncertainty merely to make two tables agree.
Worked review
For example, a narrative says a medicine was stopped while the clinical file shows ongoing use. Source review reveals confusion between a temporary interruption and permanent discontinuation. Authorised staff clarify the distinction, records are corrected without losing it and the relevant specialist assesses effects on the safety evaluation.
Practical checks
- Compare medicine identity and exposure periods with the event timeline.
- Distinguish dose changes, temporary interruptions and permanent discontinuation.
- Check effects of corrections on narratives and related safety assessments.
Acceptance and limits
Acceptance requires consistent meaning and a clear source basis for the treatment change. Identical wording in two systems is insufficient. Preserve missing information as an open question; operational matching should not replace clinical causality or reporting conclusions.
Frequently asked questions
- Does the same active-substance name prove a match?
- Context matters. Review relevant information such as product representation, dose and period of use together.
- Can reconciliation change treatment?
- This process does not decide treatment. Appropriately qualified responsible clinicians make such decisions through their own processes.