What is Patient Safety Narrative?

A patient safety narrative provides a full and clinically relevant, chronological account of the progression of an event experienced during or immediately following a clinical study


What is the purpose of patient safety Narratives?

Patient narratives are written for

  • Each Deaths, event outcome is fatal
  • serious adverse events (SAEs),
  • Adverse events of special interest due to clinical importance, this may include events that lead to study drug discontinued
  • Abnormal Laboratory findings

These narratives are placed either in the text of the clinical study report or attached in section 14.3.3. As per International Conference on Harmonisation (ICH) E3 (Section 12.3.2), a patient narrative should capture following information

  • The nature, intensity and outcome of the event
  • Clinical course leading to the event
  • Timing of investigational product administration
  • Relevant laboratory parameters
  • Whether the drug was stopped, if yes; when
  • Action taken with the study drug in relation to the event
  • Post mortem findings (if applicable)
  • Investigator’s and sponsor’s statement on causality

Additionally, it describes the patient demographics (age, sex, and country), general clinical condition of patient, disease being treated with duration of illness, relevant medical history and concomitant medication.

What are the Source documents for Safety Narratives?

Narratives are created from clinical data collected during study. Information can be gathered from followings:

  • Patient profiles and listings
  • Safety data is extracted from Council for International Organisations of Medical Sciences [CIOMS]form or MedWatch form
  • Case Report Form [CRF]
  • Data Clarification Form [DCF]