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Explaining open safety reconciliation differences at a data cut

Keep unresolved differences and their decision impact visible when information is cut for a defined purpose.

Representative research photograph: Explaining open safety reconciliation differences at a data cut
Photo: National Center for Advancing Translational Sciences from Bethesda, MD · License: Public domain · Cropped and resized.
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A data cut does not mean that every reconciliation difference has been resolved. Concealing open items prevents reviewers from understanding the limits of available information. State which record each difference affects, what is known and which assessment remains pending.

Scope of the decision

An open-item list should contain more than counts. Distinguish identity matching, event content, follow-up outcomes and technical transfer issues. Purpose matters: the same discrepancy may have different implications for an operational report and a critical safety assessment.

Worked review

For example, three event outcomes differ between sources while a period-end report is being prepared. Instead of ignoring the differences or forcing agreement through assumptions, the team lists their scope and the expected information. An authorised safety reviewer assesses effects on report use and defines how later information enters the appropriate version.

Practical checks

  • Link each difference to affected records, known information and the explanation needed.
  • Refer important uncertainty and its decision impact to the appropriate specialist.
  • Explain versioning and assessment routes for updates received after the cut.

Acceptance and limits

Acceptance is not a universal requirement that every difference be closed. Provide sufficient, honest scope information for an authorised decision. Accepting an open item does not mean resolving it; maintain ownership and appropriate follow-up. Assess regulatory or reporting requirements through their relevant processes.

Frequently asked questions

Can a report ever be produced with open differences?
There is no universal answer; purpose, importance and applicable requirements need authorised assessment.
Does a zero-difference report establish assurance?
Not if definitions or scope are incomplete. Make the records actually compared visible as well.

Sources

  1. EMA — ICH E2A clinical safety data management
  2. EMA — ICH E6 good clinical practice