Usage Examples
- The pivotal Phase 3 CSR carried 342 patient narratives, one for every death and other serious adverse event.
- Medical review flagged eleven patient narratives where the stop date disagreed with the 14.3.2 listing.
- We moved the patient narratives into section 14.3.3 because 300 of them made the safety section unreadable.
What is Patient Narrative?
A patient narrative is the case-level prose account of one trial subject's death, serious adverse event, or other significant adverse event, written for the clinical study report rather than for expedited safety reporting.
Patient narratives exist because a frequency table cannot answer the question a reviewer actually asks about a death: what happened to that person, in what order, and was the drug involved. ICH E3, finalised at Step 4 on 30 November 1995, therefore requires a brief written account of each death and each other serious adverse event to sit alongside the tabulated safety data.
Patient narratives cover every death, every other serious adverse event, and those other significant adverse events judged to be of special interest because of clinical importance. Events clearly unrelated to the investigational product may be omitted or described very briefly. Patient narratives are not written for routine non-serious adverse events, which belong in the by-patient adverse event listing instead.
Patient narratives are built from the clinical database and the by-patient adverse event listing, then medically reviewed before the clinical study report is finalised. Patient narratives sit either in the body of the report or, when the count runs to hundreds, in section 14.3.3 with a cross-reference from the safety evaluation. A narrative is also written for any laboratory abnormality treated as a serious adverse event.
Not to be confused with
- Case report form (CRF)
- a CRF holds the raw data captured for a subject at each visit; a patient narrative is the written clinical account of one event assembled from that data. ICH E3 asks for both and files them separately: CRFs for deaths, other serious adverse events and withdrawals for AE go in the report appendices, narratives in section 12.3.2 or 14.3.3.
- Adverse event listing
- a listing is one tabular row per event with fixed fields; a patient narrative is prose that establishes sequence, dechallenge, and causality reasoning for one subject. A narrative that only restates the listing row has added nothing.
- ICSR case narrative
- an ICSR narrative supports an individual case safety report filed while the trial is running, against the ICH E2A expedited clock of 7 calendar days for fatal or life-threatening unexpected ADRs and 15 for other serious unexpected ADRs. A patient narrative has no expedited clock; it is compiled after database lock for the clinical study report.
- Patient-reported outcome data
- PRO instruments capture how a subject felt or functioned as an efficacy measure; a patient narrative documents a safety event and its clinical course.
ICH E3 sets the narrative content, 21 CFR 314.50 sets what supporting case data ships with a US NDA, and ICH E2A governs the separate expedited clock.
What you must do
- 1Write a brief narrative for each death, each other serious adverse event, and each other significant adverse event judged to be of special interest because of clinical importance, and place the set either in the report text or in section 14.3.3 depending on its sizeICH E3 §12.3.2
- 2Describe in each narrative the nature and intensity of the event, the clinical course leading up to it with timing relative to study drug administration, relevant laboratory measurements, whether the drug was stopped and when, countermeasures, post mortem findings, and both the investigator's and the sponsor's causality opinionsICH E3 §12.3.2
- 3Treat marked haematological and other laboratory abnormalities, and any event that led to withdrawal of treatment, dose reduction, or significant additional concomitant therapy, as an other significant adverse event when scoping the narrative setICH E3 §12.3.1.3
- 4Provide a narrative for each patient whose laboratory abnormality was considered a serious adverse event, under section 12.3.2 or 14.3.3ICH E3 §12.4.2.3
- 5Include in a US NDA copies of individual case report forms for every patient who died during a clinical study or did not complete it because of an adverse event, including patients on reference drug or placebo21 CFR 314.50(f)(2)
- 6Report a qualifying serious unexpected adverse drug reaction on the expedited clock while the trial runs, no later than 7 calendar days for fatal or life-threatening cases and 15 calendar days for other serious unexpected reactions, independently of the patient narrative written later for the clinical study reportICH E2A §III.B
Common mistakes
Writing a narrative that is a reformatted listing row
restating the fields already in the 14.3.2 listing without the clinical course, the timing relative to dosing, the countermeasures, and the causality opinions misses what ICH E3 §12.3.2 asks for, and the reviewer comes back with an information request that costs review-cycle time.
Applying "clearly unrelated" too aggressively
ICH E3 permits omitting or briefly describing events clearly unrelated to the investigational product, but any event with a plausible drug explanation does not meet that bar. Cutting the narrative removes the record that would have carried the causality argument later.
Letting the narrative disagree with its own source data
dates, doses, stop dates and outcomes that differ between the narrative, the 14.3.2 listing, and the CRF turn a safety question into a data-integrity question, which is a far more expensive conversation.
When This Matters
- The pivotal Phase 3 CSR carried 342 patient narratives, one for every death and other serious adverse event.
- Medical review flagged eleven patient narratives where the stop date disagreed with the 14.3.2 listing.
- We moved the patient narratives into section 14.3.3 because 300 of them made the safety section unreadable.
Frequently Asked Questions
ICH E3 requires a narrative for each death, each other serious adverse event, and each other significant adverse event judged to be of special interest because of clinical importance. Events clearly unrelated to the investigational product may be omitted or described very briefly. A laboratory abnormality treated as a serious adverse event also needs one.
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