Narrative Writing for Case Processing & Aggregate Reports · Section 5.5
~6 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
By the time a narrative is being written, the case has usually already been through MedDRA coding — the events have LLTs attached, and the writer’s job is partly to describe, in prose, what those coded terms represent clinically. This is a genuinely different skill from coding itself, and it’s easy to get backwards: writing that treats the coded terms as the vocabulary the narrative has to use, rather than treating the clinical picture as the thing being described, with the codes existing to make that picture searchable.
The tell is a narrative that reads like a list: "Patient experienced pruritus, urticaria, and angioedema" is technically accurate and completely lifeless — it’s the MedDRA terms with commas between them, not a description of what actually happened to a person. "The patient developed itching, hives, and swelling of the face and lips within 30 minutes of the dose" describes exactly the same clinical picture, in language a clinician reading the case would recognise as a real account of an event, not a coding printout.
This matters for more than readability. A narrative and its coded terms are meant to be two views of the same underlying case, and when they diverge — the narrative describes something that was never coded, or a code exists with nothing in the narrative to support it — that’s a genuine quality signal, not a stylistic mismatch. A QC reviewer checking a case will often read the narrative first specifically to see whether the coded terms it implies match the terms actually selected in Module 4’s coding step; a mismatch there is one of the more common findings in narrative quality review.
Getting this right in practice means writing the clinical description first, in the way a clinician would actually describe the event, and treating the coded LLTs as a cross-check afterward rather than a script to write from. If the narrative can’t be written naturally without a term, that’s often a sign the coding needs a second look — either the term is too granular for what was actually reported, or something relevant was reported but never coded at all.
Note
Weak: "Patient experienced pruritus, urticaria, and angioedema." Strong: "The patient developed itching, hives, and swelling of the face and lips within 30 minutes of the dose." Both describe the same coded terms — pruritus, urticaria, angioedema — but the second reads like a case being described by a clinician, not a list being read off a coding screen.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. What’s the actual problem with a narrative that reads "Patient experienced pruritus, urticaria, and angioedema"?
2. Why does a mismatch between a narrative’s description and its coded MedDRA terms matter beyond style?