Regulatory Medical Writing

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Regulatory Medical Writing The Challenges
of Writing Patient Narratives
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• 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.

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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)
• Investigators and sponsors opinion on causality

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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

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Steps to Overcome the Challenges of Writing
Effective Patient narratives
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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

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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. 
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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. 

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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. 

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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.

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E-mail project_at_cognibrain.com
Phone [phone] URL https//www.cognibrain.
com/