Challenges with creating CSR Narratives
- Narrative categories
A narrative needs to be drafted for each participant in a clinical trial who experienced an event that fulfilled the criteria outlined in the regulatory guidelines. This means the Sponsor needs to prospectively determine which categories of events they consider to warrant a narrative (the “triggering events”).
Only one narrative can be produced per subject but that subject may fall into more than one category (for example if they had a serious adverse event [SAE] that led to death then they would fall into both the SAE and Death categories). - Timelines
The CSR is drafted at the very end of the study, during a very busy period of analysis, at a time when much of the ongoing monitoring for the trial has finished and the team are being pulled onto other projects. Much of the narrative is tabulated and requires programming to generate the tables, with a written (“prose”) summary portion at the end. The narratives are usually generated using templated programmes that apply to the final datasets, therefore they cannot be produced until the very end of the process. If this is a pivotal study the clinical team will be busy with the writing of critical documents for the submission of a marketing application. This leaves very few people to write the narratives and a very short time to produce them.
Even if this is not a pivotal study the number of narratives and the short timeline means it is usually an impossible task for the Sponsor to create these in house. - Technical
Narratives are generally provided as an appendix therefore they need to be created in the appropriate “house-style” and concatenated into the appropriate format for incorporation into the rest of the CSR.
Despite appearing in multiple categories only one version of the narrative must be presented in this section to minimise the size of the document, therefore the positioning must be carefully considered for each narrative to eliminate duplication.
Specific hyperlinks to each narrative from correctly formatted cover pages are required to facilitate regulatory review.
These factors require a high level of technical medical writing skills.
Pharmora Team Approach
The Safety Narratives Team is made up of scientists and medics who are experienced in writing safety narratives specifically for CSRs. Pharmora will assign a team of people to each project who can perform the following tasks:
- Medical writing of the written part of the safety narrative:
- This includes re-writing if the prose part is programmed;
- Quality Control:
- This includes cross checking the information in the written section with the tabulated part and alignment with the client template;
- Medical Review:
- Ensuring the narrative provides the appropriate context for the triggering events
Why is Pharmora so good at producing high quality CSR safety narratives?
Pharmora’s mission is “Quality without compromise”. We aim to meet or even exceed client expectations and the work of our well-trained team on safety narratives is no exception.
Our head office is based in Cheshire, UK, therefore the quality of our written English is excellent.
We treat each narrative package with respect and prepare Pharmora writing conventions specific to the particular needs of the project. Pharmora could use the client’s template or provide our own. We work with the client team to ensure the overall process and final delivery meets their demands. We provide small sample batches that cover as many categories and discussion points as possible to make the best use of the client’s time when providing feedback. Pharmora then produces consistent, high quality CSR safety narrative batches, minimising the time needed for client review, and incorporates any final comments swiftly and accurately.
Unlike medical writing service providers, medical review is integral to our approach. Unlike large CROs Pharmora does not charge the earth for this high quality service!
See our “Top tips” blog for creating your own narratives, or contact us for a quote for our service. Contact Form / mailto:info@pharmora.solutions
