Patient/Safety narratives are important documents of clinical study reports writing and pharmacovigilance activities. 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.

1. Regulatory Medical
Writing: The Challenges of
Writing Patient Narratives

2. Patient/Safety narratives are important
documents of clinical study reports writing and
pharmacovigilance activities.
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.
Reporting of these adverse events leads to
the discontinuation of the drug from a clinical
trial.

3. 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

4. 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

5. Steps to Overcome
the Challenges of
Writing Effective
Patient narratives

6. 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

7. 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.

8. 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.

9. 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.

10. 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.

11. E-mail: project@cognibrain.com
Phone: 044-49595223
URL: https://www.cognibrain.com/