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Challenges of Writing Patient / Safety Narratives - Part 1


patient narratives

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. Part 1 of this blog describes the scope of narrative projects and outlines the associated challenges. In Part 2, we provide some ideas to help you successfully manage narrative projects.

Patient narratives are written for deaths, serious adverse events (SAEs), or adverse events (AEs) of special clinical interest (eg, AEs associated with the mechanism of action being studied, laboratory results of special interest, regulatory requirements etc) and those leading to permanent discontinuation from a clinical trial. Patient narratives form an important component of clinical study reports (CSRs) and pharmacovigilance activities (eg, post marketing safety reports). As per International Conference on Harmonisation (ICH) E3 (Section 12.3.2), a patient narrative should describe:

  • the nature, intensity and outcome of the event,
  • clinical course leading to the event,
  • timing of study drug administration,
  • relevant laboratory measures,
  • counter measures,
  • action taken with the study drug in relation to the event,
  • post mortem findings (if applicable), and
  • investigator’s and sponsor’s opinion on causality.

Additionally, patient identifier, age, gender, clinical condition, disease being treated, relevant medical history, concomitant and prior medications should be included.

All this information is extracted from the source files (eg, Council for International Organisations of Medical Sciences [CIOMS] form, Case Report Form [CRF], MedWatch form, Data Clarification Form [DCF], summary tables, and listings). Sometimes, the CIOMS form can be directly attached as an appendix to the CSR.

An early challenge, for sponsors, is to identify the approximate number of narratives to be produced, which further determines the narrative format and timing of production (pre- or post database lock). If narratives are written before the data are final, updates are required based on the final clean data. This approach can be time consuming, but is more feasible for projects where a large number of narratives have to be produced and finalised quickly eg, for a regulatory submission. Medical writers can provide effective guidance to clinical study teams during this process.

The majority of Phase II and Phase IV studies have a large number of patients meeting the narrative criteria as outlined in the narrative plan. Excellent project management skills are essential for tracking such projects where huge volumes of narratives have to be written, often by a team of medical writers. The importance of careful management should not be under estimated; ensuring accuracy and consistency across a large number of narratives is a time consuming and tricky task!

In a Clinical Research Organisation (CRO), completing a narrative project within a pre specified budget and time, whilst maintaining quality can be extremely critical for the writers and the business as a whole. As soon as possible, team agreement on the style and content should be sought; this will reduce the possibility of valuable time being lost due to changes requested by the study team during the project lifecycle.

Narrative writing involves expressing the messages clearly and effectively, whilst collating the relevant information from various sources, and liaising with medical experts. A narrative tells the complete story chronologically and holds together medically. Identifying and relating the ‘relevant’ medical history or laboratory result to the event of interest can be challenging.


Patient Safety Narratives


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Can you identify a good tracking system when writing narratives on an active study protocol so the system is triggered when a narrative will need to be updated when new SAE's are reported?
Posted @ Tuesday, October 11, 2011 2:22 PM by Lisa Virzi
Hi Lisa 
Many thanks for your question. To track narratives we tend to use a simple excel-based spreadsheet which captures the key patient information such as PID and randomisation number in addition to narrative status. Any new SAEs being reported for a particular patient are linked to an existing narrative via the patient identifier. I don’t know of any specific software with an automatic trigger, but sometimes we find that keeping it simple can be the best approach.
Posted @ Wednesday, October 12, 2011 9:38 AM by Medical Writers Team
what is the average time for each narrative, is two hours per patient reasonable provided that data are clear after lock? 
Posted @ Monday, November 14, 2011 4:21 PM by ilian doba
As for most documents, the time required for preparation depends on a number of factors such as data quality, type of narrative required (prose or hybrid) and level of complexity. You also need to factor in the review and QC steps. In my experience for the majority of patient narratives a total preparation time of between 1 and 3 hours is a reasonable estimation.
Posted @ Friday, November 18, 2011 4:50 AM by Medical Writers Team
v nice. useful info. thank. you.
Posted @ Sunday, July 21, 2013 9:43 AM by Rishita Buddha
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