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Regulatory Medical Writing


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 – PowerPoint PPT presentation

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Title: Regulatory Medical Writing

Regulatory Medical Writing The Challenges
of Writing Patient Narratives
  • 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.

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

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

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
  • 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
  • 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
  • For a professional medical and clinical report
    writing, contact our medical writing
    services experts.

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