In this blog, you’ll discover:
- Why ICSR narratives are important.
- Crafting better ICSR narratives.
- What to include and avoid in your narrative.
Table of Contents:
- The Importance of ICSR Narratives
- Auto-Creation of Narratives
- The Chronological Structure of ICSR Narratives
- Essentials, Choices and what to avoid
- Conclusion
The Importance of ICSR Narratives
In the process of handling an ICSR case, one crucial element stands out: the narrative.
From various angles, narrative writing might seem daunting and complex. However, in my view, this perception is just a misconception. It’s not as overwhelming if you’re clear about what to include and what to leave out. Let’s explore how to craft it effectively.
Many wonder why it’s necessary to write a separate narrative when we already input case data into electronic databases.
Here are a few key reasons:
- Mandatory Requirement: The ICH E3 guidelines make it mandatory to write a narrative for every case file.
- Comprehensive Summary: It provides a concise summary of the entire case story.
- Identification of Missing Data: It helps in identifying any data that might have been missed during coding.
- Drawing Efficacy Conclusions: The narrative aids in drawing conclusions about the effectiveness of the treatment.
Auto-Creation of Narratives
In SAS programs, there’s an option for automatically generating narratives. Many programmers contribute to developing this automation, which is crucial for creating ICSR narratives.
This automation requires input data coded within the database. To create this integration, it’s essential to follow important regulations to ensure the desired outcome.
“Crafting an ICSR narrative is not just about reporting data; it’s about painting a vivid picture of the patient’s journey, ensuring each detail contributes to a clearer understanding of safety concerns and ultimately, a safer healthcare landscape.”
It’s not considered best practice to leave a narrative as it is generated. In many cases, it might lack proper chronology and may only capture “PT” without the verbatim details.
Therefore, reviewing, arranging, and rewriting a narrative is always advisable to ensure accuracy and completeness.
Structured Narrative Arrangement
The order of the details below may change depending on the chronological sequence of events.
- If applicable, start with a unique case number.
- Report type and reporter’s information. (maintain anonymity)
- Share information about the patient, including demographics, age, and gender.
- Describe the patient’s medical history or any current conditions they have. (Learn more…)
- Include information about any other drugs or medications the patient (is taking/taken).
- Describe the suspected drug or product involved in the event, including when it was administered and how.
- Include any relevant findings from laboratory tests.
- Outline the sequence of events and when they occurred.
- Describe the nature and intensity of the events, as well as their outcome.
- Detail any treatments the patient received.
- Explain any actions taken in response to the event.
- If applicable, provide information about any attempts to discontinue and then restart the suspected drug.
- If the case is serious and fatal, include details from any autopsy or postmortem examination.
- Summarize the final outcome of the event.
- Provide information on the assessment of the event’s causality, including assessments from both the reporter and local medical professionals.
- Include any additional comments, if available or relevant.
Follow-up narrative
Follow-up cases occur when additional information is received regarding an existing case. Narratives also need to be amended.
The following details are relevant only for follow-up cases with significant new information:
- Rewrite the narrative only if there is significant new information received in the follow-up report. If the follow-up report contains no significant data, there’s no need to rewrite the narrative.
- Following company conventions, some may require updating the main narrative with new information while also adding a separate paragraph to highlight the added details.
- Ensure that the chronological order is maintained in both the original and rewritten narrative, incorporating any new information received in the follow-up report.
Essentials, Choices and what to avoid
| Essentials | Choices | To avoid |
|---|---|---|
| Maintain Chronology from beginning to end | Mentioning case file number | Non-significant lab data |
| Include Crucial Medic Comments if necessary | Repetitiveness when only necessary | Repetitive of details |
| Capture of events as it reported | Unnecessary spaces | |
| Crucial Uncodable Data Mentioned | Passive voices | |
| Maintain anonymity of patient details | Comment on Linked Cases (Follow Conventions) | Maintain Anonymity of Patient Details. Avoid Mentioning Very Personal Patient Details (For example: Name of the patient, even it reported) |
| Any major change of crucial data during FU | ||
| Describe the entire linked case if both parents’ pregnancy cases involve drug exposure. |
Conclusion
This detailed and informative blog can provide you with a clear understanding of how to create an ICSR narrative and the key elements to include in both initial and follow-up reports.
Additionally, we’ve explored various areas within the narrative section of ICSRs, with internal links for easy navigation. Take the opportunity to gain valuable insights to improve your quality score.
If you have any additional details to add or if something is missing, feel free to reach out to us.
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