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Matching symptom and diagnosis records in adverse events

Resolve relationships between symptom and diagnosis entries without losing genuinely separate clinical events.

Representative research photograph: Matching symptom and diagnosis records in adverse events
Photo: U.S. Navy photo by Photographer's Mate 3rd Class Jason T. Poplin · License: Public domain · Cropped and resized.
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An event may first be recorded as a symptom and later as a diagnosis. Similar entries are not automatically duplicates; they may also describe separate clinical events. Reconciliation should help explain the relationship through authorised clinical assessment rather than making a diagnosis itself.

Scope of the decision

Review onset dates, the event course, descriptions and investigator assessments together. A decision to link or retain separate entries should remain traceable without silently deleting source information. Convenient coding does not replace preservation of clinical meaning; uncertain matches belong with the responsible expert.

Worked review

For example, one participant has an initial shortness-of-breath entry followed by a more specific diagnosis. Operational staff do not delete an entry simply because the dates are close. They request information explaining whether the investigator considers these one evolving event or separate events, then establish the appropriate record relationship.

Practical checks

  • Compare symptom and diagnosis timelines within their source context.
  • Check that the relationship decision reflects authorised clinical assessment.
  • Revisit event counts and linked follow-up records after any change.

Acceptance and limits

Acceptance means that the relationship is understandable and original information remains traceable. The objective is not to make the event table smaller. If information is insufficient, preserve uncertainty rather than treating an automated match as a definitive clinical or reporting conclusion.

Frequently asked questions

Are entries starting on the same date one event?
Not necessarily. Clinical meaning and source explanations determine the appropriate relationship.
Does a coding change alter the clinical judgement?
Not on its own. Coding and clinical assessment are separate but connected activities.

Sources

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