Patient narratives are an important part of clinical study report (CSRs) and pharmacovigilance activities.Patient Narrative is written for deaths, Serious Adverse Events, other events of clinical interest.
Good written communication and data presentations skills are essential. There should be a good understanding of requirements by all parties, sponsors and other stakeholders with the agreement of the scope and main principles prior to project start.
The medical writer writes the patient safety narrative providing a comprehensive and clinically relevant data describing the results of an event experienced during or following a clinical study in a chronological manner
As Per ICH E3 guidelines, a patient safety narrative should describe the following:
- the nature, intensity, and outcome of the event
- the clinical course leading to the event
- timing when the drug was administered
- relevant laboratory measures
- action taken with the study drug in relation to the event
- treatment or intervention
- post-mortem findings
- Investigator’s and Sponsor’s opinion on causality
Narratives should include the following:
- patient identifier
- age and sex of patient; general clinical condition of patient, if appropriate
- disease being treated with duration of illness
- relevant concomitant/previous illnesses with details of occurrence/duration
- relevant concomitant/previous medication with details of dosage
- test drug administered, including dose, if this varied among patients, and length of time administered
It is important to identify the approximate number of patient safety narratives to be prepared early in the planning process as this determines the narrative format and impacts the timing of production.
In a Clinical Research Organisation (CRO), completing a patient narrative project within a predetermined budget and time and maintaining a standard of quality is critically important for the writers and the business as a whole.
Source of information used by a Medical Writer when writing patient safety narratives
- Council for International Organizations of Medical Sciences (CIOMS) forms
- Case Report Forms (CRFs)
- MedWatch forms
- Data Clarification Forms (DCFs)
- Clinical database listings
- Medical Writer prepares a narrative template using various data sources like CRF pages, analysis datasets, pharmacovigilance database, clinical database listings
- Peer and scientific review by the CRO project lead to check the document is accurate, complete, and consistent with requirements.
- Clinical review of draft narrative by the Sponsor, Stakeholders
- Re drafting narrative after clinical review comments: If the writer does not agree with clinical review comments, when the review comments are unclear, a conflict with the evidence, these should be discussed with the Sponsors or other stakeholders and duly noted and filed.
- Quality control (QC) review is based on final patient data. Due to the large number of narratives required for individual studies and small size of each document relative to the CSR, it is recommended that a single QC review be performed toward the end of the process, rather than QC review of the first draft and final deliverable.
- Approval by the Sponsor after a final review
For more information please Click here
James Lind Institute is one of the leading global education institutes that provide specialized online training and education programs in medical writing. Currently available online professional training programs in medical writing are: