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Reconciling death and last-contact dates in safety records

Preserve the meaning of different date fields when referring critical outcome discrepancies for authorised review.

Representative research photograph: Reconciling death and last-contact dates in safety records
Photo: MatasNavickas · License: CC BY-SA 4.0 · Cropped and resized.
Published
Updated

Death date and last-contact date represent different concepts and need not be equal. Conflicting sources or an unexplained sequence nevertheless require assessment of critical outcome information. Reconciliation staff should support appropriate source and clinical review rather than inventing an unknown date.

Scope of the decision

Explain what each field represents and the source supporting it. Do not confuse the date information was received with the date an event occurred. Where information is partial or estimated, study data rules and authorised assessment determine its representation. Missing information should not be silently converted into a certain date.

Worked review

Suppose the clinical file shows last contact after the death date in the safety record. Review establishes that the entry describes when information was received from a relative. The field meaning was misapplied. The team verifies context, makes the appropriate correction and examines affected reports rather than simply changing the event date.

Practical checks

  • Distinguish occurrence, awareness and communication dates by their meaning.
  • Investigate conflict through authorised sources and appropriate clinical assessment.
  • Check effects on outcome, follow-up and related reporting records.

Acceptance and limits

Acceptance means coherent explanations and supporting sources, not making every date identical. Unknown information may remain uncertain. Use the appropriate safety process when new critical information or reporting assessment is required; a data-cleaning record does not replace it.

Frequently asked questions

Is the most recent date automatically correct?
No. It may describe another event or the time information was received.
Should a standard day fill a missing date?
Do not assume this universally. Follow appropriate data rules and authorised assessment while preserving uncertainty.

Sources

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