Narrative writing is one of the most crucial steps in case processing. It is the story of the adverse event (AE) — a continuous, medically coherent summary of what happened to the patient, presented in chronological order.

It must allow any reviewer (regulator, QA, auditor, medical monitor, sponsor) to understand the case without reading the source documents.

Purpose of Narrative Writing

The narrative aims to:

• Present a clear, concise, chronological medical story
• Explain:
• What happened
• When it happened
• Why it happened (temporal relationship)
• How severe it was
• What treatment was given
• What the final outcome is
• Provide medically meaningful context for expectedness and causality assessment.

🧩 Components of a High-Quality Narrative

A good narrative generally includes the following:

1.      Patient Information

• Age, gender, or age group
• Relevant medical history
• Past or current medical conditions
• Concomitant medications
• Relevant social history (smoking/alcohol, if medically relevant)

Example:
"The patient was a 54-year-old male with a history of hypertension and type 2 diabetes."

2.      Suspect Drug Information

For each suspect product:

• Name (brand & generic)
• Formulation
• Dose, route, and frequency
• Indication for use
• Start and stop dates
• Batch/lot number (if available)

Example:
"The patient began treatment with Metformin 500 mg orally twice daily for diabetes on 12-Jan-2024."

3.      Concomitant Medication Information

Include only those relevant to the medical context:

• Drug name
• Dose
• Indication

4.      Event Description — THE CORE OF THE NARRATIVE

This is the chronological story:

🔸 Start with onset of the event

• Date of onset
• Symptoms
• Clinical findings
• Patient-reported or medically confirmed?
• How was the event discovered?

🔸 Details of the clinical course

• Progression, worsening, or improvement
• Treatments given (hospitalization, ER visits, medicines)
• Laboratory tests or diagnostic results
• Vital signs
• Physician interventions

🔸 Outcome

• Recovered, recovering, not recovered, fatal, unknown
• Date of outcome if known

Example:
"On 20-Jan-2024, after two weeks of Metformin therapy, the patient developed severe abdominal pain and vomiting. The patient visited the emergency department, where metabolic acidosis was noted (pH 7.2). Metformin was discontinued the same day. The patient was admitted and treated with IV fluids. Symptoms improved gradually, and the patient was discharged on 23-Jan-2024."

5.      Relevant Labs/Tests

Include medically meaningful results only:

• CBC, LFT, RFT
• Imaging findings (CT/MRI/X-ray)
• Any diagnostic confirmation

6.      Dechallenge and Rechallenge

Dechallenge

What happened when the drug was stopped?

• Positive → Event improved after stopping
• Negative → No improvement
• Not applicable → Drug not stopped

Rechallenge

What happened if the drug was restarted?

• Positive → Event recurred
• Negative → No recurrence
• Not done

7.      Causality Assessment Summary

This section integrates:

• Temporal association
• Biological plausibility
• Confounders
• Dechallenge/rechallenge results

Written as:

• Related / Possibly related / Unlikely related / Not related

8.      Case Closure Summary

1–2 lines summarizing the case:

• "A serious unexpected case of XXX possibly related to YYY in a patient with Z medical history."

Example of a Well-Written Narrative (Short Version)

“The case involves a 54-year-old male with hypertension and diabetes who started Metformin 500 mg orally twice daily on 12-Jan-2024. On 20-Jan-2024, he developed severe abdominal pain and vomiting and presented to the ER. Investigations revealed metabolic acidosis (pH 7.2), suggesting possible Metformin-associated lactic acidosis (MALA). Metformin was discontinued the same day. He was hospitalized and treated with IV fluids. Symptoms resolved, and he was discharged on 23-Jan-2024. A positive dechallenge was noted. No rechallenge was performed. Based on temporal association and improvement after stopping the drug, the event was assessed as possibly related to Metformin.”

Best Practices for Narrative Writing

✔ Maintain chronological order
✔ Stick to medically relevant details only
✔ Avoid assumptions or personal judgment
✔ Ensure consistency with:

• Case form fields
• Medical coding
• CIOMS standards

✔ Use third-person, past tense
✔ Avoid copying from source verbatim—summarize clearly

 

Simple AE Narrative – Sample Case

Patient Information:

This case concerns a 32-year-old female (weight and height not reported) with no significant past medical history. No allergies or relevant family history were reported. No concomitant medications were in use at the time of the event.

Suspect Product Information:

The patient self-initiated treatment with Ibuprofen 400 mg, orally, as needed, for headache on 05-Aug-2024. Batch/lot number and expiry date were not provided.

Event Description:

On 05-Aug-2024, approximately one hour after taking a single 400 mg dose of Ibuprofen, the patient experienced mild gastric discomfort characterized by abdominal pain and a burning sensation in the upper abdomen. The event was non-serious, self-limited, and did not require medical intervention or hospitalization.
The patient did not seek medical consultation; however, she discontinued Ibuprofen on the same day. The symptoms resolved spontaneously within a few hours.

Relevant Tests/Laboratory Data:

No laboratory investigations or diagnostic tests were performed.

Dechallenge/Rechallenge:

A positive dechallenge was observed, as symptoms resolved after discontinuation of the suspect product. Rechallenge was not attempted.

Outcome:

The patient fully recovered on the same day (05-Aug-2024).

Causality Assessment:

Based on the temporal association, known pharmacological effects of NSAIDs, and positive dechallenge, the event of gastric discomfort was assessed as related to Ibuprofen.

Case Summary:

This is a non-serious spontaneous case of gastric discomfort associated with Ibuprofen use in a 32-year-old female, resolving spontaneously following drug discontinuation.

 

 

 

Serious AE Narrative – Sample Case (Hospitalization)

Patient Information:

The case involves a 58-year-old male (weight and height not reported) with a medical history significant for type 2 diabetes mellitus and hypertension. Past surgical history, allergies, and family history were not reported. Concomitant medications included Amlodipine 5 mg once daily for hypertension and Metformin 1000 mg twice daily for diabetes.

Suspect Product Information:

The patient started Amoxicillin–Clavulanic Acid 625 mg, orally twice daily, for acute sinusitis on 10-Sep-2024. Batch/lot number and expiry details were not provided.

Event Description:

On 11-Sep-2024 (one day after starting therapy), the patient developed generalized itching, followed by rapid-onset swelling of the lips and eyelids and shortness of breath within minutes. Emergency medical services were contacted, and the patient was transported to the hospital. Upon arrival, he was diagnosed with acute anaphylaxis based on clinical presentation, including:

• Facial angioedema
• Wheezing
• Hypotension (BP 86/54 mmHg)
• Urticaria over the trunk

The patient was immediately treated with intramuscular epinephrine, IV antihistamines, and IV corticosteroids. Amoxicillin–Clavulanic Acid was discontinued upon admission. He was monitored in the emergency department and subsequently admitted for observation for 24 hours.

Symptoms improved significantly over the next several hours. The swelling and breathing difficulty resolved completely by 12-Sep-2024, and the patient was discharged in stable condition.

Relevant Laboratory/Diagnostic Data:

No specific allergy testing or laboratory results were provided. Diagnosis was clinical, based on signs and symptoms.

Dechallenge/Rechallenge:

A positive dechallenge was noted, as symptoms resolved following discontinuation of the suspect drug and receipt of appropriate treatment.
Rechallenge was not performed, due to the nature of the reaction (life-threatening hypersensitivity).

Outcome:

Recovered on 12-Sep-2024.

Causality Assessment:

Considering the rapid temporal association, clinical presentation typical of β-lactam allergy, absence of alternative explanations, and positive dechallenge, the event of anaphylaxis was assessed as related to Amoxicillin–Clavulanic Acid.

Case Summary:

This is a serious spontaneous case of drug-induced anaphylaxis requiring hospitalization in a 58-year-old male following administration of Amoxicillin–Clavulanic Acid for sinusitis. The event resolved after drug discontinuation and appropriate medical management.