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Narrative Writing in Pharmacovigilance

Clinical ResearchPharmacovigilance

Narrative Writing in Pharmacovigilance

Narrative writing is an important part of Pharmacovigilance and in patient safety as well. Usually patient narratives are written in case of Adverse Events and Serious Adverse Events including deaths. Patient narratives form a very important part of clinical study reports and all other post marketing activities. In case of a Serious Adverse Event it is the Principal Investigator or someone else delegated by he/ she  who writes the narrative. A well defined narrative should contain the following points:

  • Medical Review covering all aspects
  • The relevant clinical information should be summarized
  • The narration should be concise and comprehendible, following a chronological order.
  • Report submission should be in a format prescribed by regulatory authorities
  • The study team, including nurses should be fully capable and should have expertise in critical care

A narrative can be defined as a summary or synopsis of the event that has occurred to a subject participating in the clinical trial. A CIOMS report can be cited as an example of a narrative which provides valuable information about the occurrence of the event. The writing style of the narrative, as already mentioned above should be in a prescribed format. The narrative must mention the subject ID of the patient, ethnicity and medical history of the patient, the reason why the study treatment is being given to be subject, a detailed version of the medical event that has occurred, what action was being taken after the event, a description if the event is any way related to the study drug or otherwise and a list of all vital signs of the subject. If there is any other notion being considered important by the delegate or the Principal Investigator writing the narrative, it should find a mention in the narrative as well.

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