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Source-version consistency in safety narratives

Keep narrative changes traceable to their sources as follow-up information develops.

Representative research photograph: Source-version consistency in safety narratives
Photo: Unknown photographer · License: Public domain · Cropped and resized.
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A safety narrative combines information received at different times. A new source may correct earlier information, add detail or increase uncertainty. Preparation should explain this development rather than assuming that the newest document automatically overrides every field.

Scope of the decision

Do not confuse source version and receipt date with the time of an event. Refer conflicting statements for authorised assessment. The certainty expressed in the narrative should match the supporting evidence; do not fill a gap with an assumption merely to produce fluent prose.

Worked review

For example, an initial report gives an approximate discharge date. A later record provides a precise date but describes onset differently. The team does not copy every date from the new document. It identifies which fact was corrected and which conflict remains, then updates the narrative with appropriate clinical review.

Practical checks

  • Map important narrative statements to the source and version supporting them.
  • Explain whether new information corrects, supplements or conflicts with earlier information.
  • Check effects on related assessments and the status of relevant reports.

Acceptance and limits

Acceptance requires source traceability and appropriate review of clinical meaning. Well-written prose cannot compensate for missing evidence. If follow-up continues, keep remaining uncertainty and the route for subsequent updates visible rather than presenting the narrative as permanently complete.

Frequently asked questions

Does the latest document invalidate every earlier fact?
No. Examine its scope and the context supporting each item of information.
May a narrative contain uncertainty?
Yes, where appropriate. Explaining what remains unknown is more reliable than expressing certainty that sources do not support.

Sources

  1. EMA — ICH E2A clinical safety data management
  2. MHRA — GxP data integrity