SAE (Serious Adverse Event) Narrative in Clinical Research
08 Jul 2017
The literary meaning of the word ‘narrative’ is ‘a spoken or a written account of connected events’.
What is SAE Narrative?
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
A SAE narrative is a detailed, stand-alone document, which presents a full and clinically relevant, sequential account of the progression of an event or events. It summarizes all relevant clinical and related information, including patient characteristics, therapy details, medical history, clinical course of the event(s), diagnosis, and AE(s) including the outcome, laboratory evidence (including normal ranges), and any other information that supports or alleges an adverse event.
SAE (Serious Adverse Event) narrative writing requires a combination of medical and technical writing skills.
What does the guideline say?
Section 12.3.2 of ICH E3 states that “There should be brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance”. In general, the narrative should describe the nature and intensity of the event, the treatment provided to the patient, relevant laboratory measurements, causality assessment, post-mortem details (if applicable) and the action taken.
The following details are also to be captured in the narrative:
- 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
- Investigational product administered, drug dose and length of time administered.
Main features of narrative writing:
How and what to capture?
Relevant information related to the event (serious / significant / death) is gathered from various sources and put together to express the event clearly and effectively. While writing a narrative, the writer has to effectively and clearly express the messages contained within the data, gather information from existing documentation and coordinate with the relevant person, generally the client’s medical monitor or the treating physician.
The flow of the narrative should be such that the reviewer is able to reconstitute the entire happening. The events should be presented in the narrative in a logical time sequence. It should preferably be presented in the sequence of the patient’s experience, rather than in the order in which the information was received. The narrative can preferably be initiated in a tabular form containing the subject’s identification number, age, the investigator’s term for the AE, the preferred term, the study drug administered, date of study drug administration, causality, severity and the outcome of the event. Thereafter, the actual narration (body of the narrative) of the SAE can be presented by appropriately distributing it in different paragraphs.
Narrating a SAE is a very crucial activity. Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle and an applicant’s narrative summaries of deaths, serious adverse events, and other events that resulted in dropouts is one of the important source material for safety review of an upcoming drug. Hence it should be taken up with utmost care.
- Should be thorough and balanced
- In-depth medical record review
- Summarization and highlight of relevant clinical information
- Presentation of concise and comprehensive narrative report in chronological sequence