Page 1

Regulatory Medical Writing: The Challenges of Writing Patient Narratives


â?–Patient/Safety narratives are important documents of clinical study reports writing and pharmacovigilance activities. â?–They are written to report deaths, serious adverse events, adverse events of special clinical interest, and any such events in a clinical trial of the drug. â?–Reporting of these adverse events leads to the discontinuation of the drug from a clinical trial.


As per International Conference on Harmonisation (ICH), a patient narrative should describe ➢The nature, intensity and outcome of the event ➢The clinical course leading to the event ➢The time when the study drug was administered ➢Relevant laboratory measures ➢Countermeasures

➢Actions taken with the study drug in relation to the event ➢Postmortem findings (if applicable) ➢Investigator’s and sponsor’s opinion on causality


Challenges of Writing Patient Narratives

➢Identify the number of narratives to write ➢The proper format and time of writing a narrative

➢To ensure accuracy and consistency across numerous narratives ➢Write a quality patient narrative within a pre-specified time and budget ➢Identify and relate the ‘relevant’ medical history or laboratory result to the event of interest


Steps to Overcome the Challenges of Writing Effective Patient narratives


1)Open Communication between the Client and Medical Writing Team

Most narrative projects fail due to a lack of communication between the client and the medical writers. The client should provide clear and detailed instructions to all the members of the study team including the medical writers. This will also save time in completing the narrative project. Provide instructions regarding: ✓Sentence structures ✓Date formats ✓Which medical history and concomitant medications are relevant ✓Inclusion or exclusion of normal ranges for laboratory results ✓Trade or generic names for drugs


2) Deliver Narratives in Batches

In case of many narratives, it's advisable to deliver them in small batches of 5-10 each.

This will save re-work and provide sufficient time for the team review.


3) Track the Patient Narratives

➢Tracking is important for projects which require writing numerous narratives for regulatory submissions. ➢Microsoft Office Excel is an excellent tracking tool to manage huge volumes of narratives.

➢You can include important dates, protocol and subject identification numbers, and events of interest in the excel sheet.


4) Decide a Project-specific Style Guide

➢When multiple writers are involved in a narrative project, things become tricky.

➢Writing new narratives according to the new specifications and updating the previous ones becomes challenging. ➢In such a case, hold regular team meetings to keep everyone updated on the latest happenings. Plus, keep a project- specific style guide with notification posts sent out to the study team whenever an update is made.


5) Assign a Time for the Quality Control Check

➢To decide the stage of narrative quality control (QC) is problematic. Therefore, perform QC at both the interim (review) and final delivery stages. ➢For a professional medical and clinical report writing, contact our medical writing services experts.


E-mail: project@cognibrain.com

Phone: 044-49595223 URL: https://www.cognibrain.com/

Regulatory Medical Writing: The Challenges of Writing Patient Narratives  

Regulatory Medical Writing: The Challenges of Writing Patient Narratives

Regulatory Medical Writing: The Challenges of Writing Patient Narratives  

Regulatory Medical Writing: The Challenges of Writing Patient Narratives

Advertisement