'Femi Fajimi

Writing Patient Narratives in Clinical Trials: A Beginner’s Guide 

By Femi Fajimi | 22 April 2025 

When I started exploring regulatory medical writing, one document type I kept coming across was the patient narrative. At first, I thought it would be a simple case summary, but I quickly discovered that writing a good narrative is about far more than just telling a story. 

Patient narratives play a key role in regulatory submissions, particularly in summarising safety data for participants who experience significant events during clinical trials. They offer a focused, factual, and chronological overview of what happened, allowing regulatory authorities to evaluate the safety of an investigational product in context. 

As a beginner, understanding patient narratives’ purpose, structure, and writing tone has been an essential learning experience. 

What Is a Patient Narrative? 

A patient narrative is a detailed, stand-alone summary of important clinical events experienced by individual participants in a trial. These events typically include: 

• Serious Adverse Events (SAEs) 

• Deaths 

• Adverse Events leading to discontinuation 

• Clinically significant abnormal lab results 

• Adverse Events of Special Interest (AESIs) 

Clinical Study Reports (CSRs) often include patient narratives, especially for trials submitted to regulatory bodies like the MHRA, EMA, or FDA. 

Purpose of the Patient Narrative 

The goal of a patient narrative is to allow reviewers to: 

• Understand the clinical context of a safety event 

• See how the participant responded to the investigational product 

• Assess whether the event might be related to the treatment 

• Evaluate the investigator’s clinical judgement and rationale for continuation or withdrawal 

In short, a narrative gives life to the data tables, providing human context to numbers. 

What Goes into a Patient Narrative? 

A typical narrative includes: 

1. Patient Demographics 

Age, sex, race, height/weight (if relevant) 

2. Medical History and Baseline Conditions 

Pre-existing conditions or relevant risk factors 

3. Treatment Information 

Start and stop dates of the investigational drug 

Dose and route of administration 

Any concomitant medications 

4. Adverse Event Description 

Event name, date of onset, severity, seriousness 

Duration and outcome 

Any action taken (e.g., dose reduction, withdrawal) 

5. Laboratory or Diagnostic Findings 

Include relevant lab results (if applicable), with dates 

6. Investigator’s Opinion 

Whether the event was related to the investigational product or not 

7. Outcome and Current Status 

Whether the participant recovered, withdrew, or died 

Follow-up details, if applicable 

This fictional patient narrative is for demonstration purposes only and does not represent a real clinical case or real participant.

My Approach to Writing Patient Narratives (As a Beginner) 

Although I’m still learning, here are some guiding principles I follow to make sure the narrative is accurate and regulatory-compliant: 

1. Stick to Source Documents 

Every statement in the narrative must come from the Case Report Form (CRF), protocol, or other verified study documentation. Nothing should be assumed or interpreted. 

2. Be Chronological 

Events are presented in the order they occurred, from drug administration through to resolution of the adverse event. 

3. Use Clear, Concise Language 

Avoid over-descriptive or emotive terms. Use neutral language. 

✅ “The participant experienced Grade 3 neutropenia on Day 14.” 

❌ “The participant suffered a severe episode of dangerously low neutrophils.” 

4. Maintain Regulatory Tone 

• Avoid ambiguity or speculation 

• Use passive constructions where appropriate to maintain objectivity (e.g., “The dose was reduced…”) 

5. Ensure Consistency 

• Use consistent units and terminology 

• Spell out terms the first time with abbreviations in brackets e.g., Serious Adverse Event (SAE).

Common Mistakes to Avoid (and What I’m Learning) 

Mistake	Better Practice
Using promotional or emotional language	Stick to factual and neutral wording
Inconsistent dates or terms	Cross-check every detail with CRF or database
Adding assumptions	Only include verified information; never interpret
Overloading with unnecessary data	Include only clinically relevant facts

Regulatory Relevance 

Patient narratives are part of the Clinical Study Report (CSR) and are often reviewed during regulatory submissions. Therefore, they must meet the expectations outlined in: 

• ICH E3 Guideline (Structure and Content of CSRs) 

• ABPI Code of Practice (accuracy, tone, and responsibility in communication) 

• GCP Requirements (truthful, traceable documentation) 

Even as a beginner, I’m mindful that a poorly written narrative can delay reviews or raise red flags during regulatory assessments, reinforcing the importance of clarity and accuracy. 

Final Thoughts 

Patient narratives are more than summaries; they’re a chance to present a snapshot of someone’s journey through a clinical trial. As a beginner, working with narratives has helped me develop my attention to detail, my understanding of safety data, and my voice as a regulatory writer. 

I’m still learning, but I see how powerful a well-structured, clearly written narrative can be for regulators, researchers, and, ultimately, for protecting patient safety. 

References 

1. International Council for Harmonisation (ICH). E3: Structure and Content of Clinical Study Reports. 1995. Available at: https://www.ich.org/page/efficacy-guidelines 

2. Association of the British Pharmaceutical Industry (ABPI). ABPI Code of Practice for the Pharmaceutical Industry 2021. Available at: https://www.abpi.org.uk 

3. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1). 2013. Available at: https://www.ema.europa.eu 

4. U.S. Food and Drug Administration (FDA). Clinical Study Reports: General Considerations for Submission. 2018. Available at: https://www.fda.gov