What are patient narratives?
Patient narratives must be included as a required part of Clinical Study Reports (CSR) for narrative‑triggering adverse event types defined by the International Council for Harmonisation (ICH). These narratives should succinctly describe pertinent safety events experienced by participants in a clinical trial.
What are the main requirements of a CSR?
The main requirements for developing informative and accurate patient narratives are:
- Comprehensive information
Our writers can help you to prepare narratives that contain the relevant essential information including study identifiers, demographics, pertinent medical history, and the safety information related to the triggering adverse event in a comprehensive yet understandable format. - Ensuring compliance
Presenting accurate information is vital to ensure compliance, credibility and reliability of the patient narratives. At Alchemy, our experienced regulatory writers are adept at safeguarding the confidentiality and privacy of study participants’ information.
How are patient narratives used within the regulatory framework?
Narratives help to provide a detailed description of adverse events experienced by study participants. This information is crucial for determining the overall risk-benefit profile of the investigational product under review. Regulatory authorities rely on narratives to understand the circumstances surrounding the adverse event, including potential causality factors and any relevant medical information, contributing to the overall safety and efficacy evaluation of the study drug or device.
Here we provide an example of a typical narrative and demonstrate how Alchemy can identify a range of potential disclosure and compliance risks, as well as some stylistic and formatting concerns.
Example of a narrative with potential disclosure/compliance risks identified
Explanation potential disclosure/compliance risks
- Depending on the disease under study, some demographic information can lead to a risk of disclosure. Although rare, in these cases demographics may have to be made more ambiguous. For example, by listing the country or region of residence, rather than a particular island.
- Calendar dates can result in unintended disclosure, so it is preferable to use study days and relative timings for data protection compliance and to reduce disclosure risk. Relative timings can be used for events outside of the study timeframe, e.g. “1 year and 10 months after the last study dose”.
- Consideration needs to be given to “relevant” medical history versus risk of disclosure. In this example, amputation presents an easily identifiable disclosure risk, greatly increasing patient identifiability.
- Brand names should not be used in patient narratives and should be replaced with generic drug names.
- If a narrative includes relatedness to a study drug, a statement of relatedness by both the investigator and sponsor should be provided.
What additional document types or materials are needed to help write narratives?
To develop comprehensive and high-quality narratives, we’ll need you to provide us with listings that contain:
- Demographics
- Adverse event data
- Prior and concomitant medications
- Medical and surgical history
- Exposure data
- Laboratory, vital sign, and other relevant safety data
We may also require:
- CIOMS (Council for International Organizations of Medical Sciences) forms/Pharmacovigilance database
- MedWatch forms (USA)
- Case report forms
What is the general timeframe for writing patient narratives?
In large studies with many narrative-triggering events, creating narratives may require a lot of time than authoring a CSR. However, in most cases, only a few narratives are required. Typically, the format we follow for narrative development is as follows:
Draft > client review > updates based on review > QC > finalisation
We often advise our clients to allow us to write a draft narrative first before proceeding to writing the rest of the narratives to confirm you are happy with the format, style, amount of information we have included from the source documents.
Alchemy’s top tips and tricks for writing narratives
At Alchemy, we prioritise early team agreement on patients who will need a narrative writing and ensure a second medical writer checks all narratives for required adverse events on your behalf. We always recommend aligning narrative review cycles with CSR review cycles to lessen review burden among your internal review teams. Lastly, a 100% data check is paramount to developing compliant, high-quality narratives.
How can I contact Alchemy about writing patient narratives?
To discuss your patient narrative writing needs, please email our team: Contact
