Patient narrative is one of the key elements while reporting about the clinical trial. It aids in analyzing the safety profile of a drug. The document includes summaries about specific events that are clinically relevant, experienced during or immediately after completion of a clinical trial. The safety narratives include events experienced by the healthy individuals and the patients enrolled in the clinical trials. These are the documents prepared every time a particular drug or investigational product undergoes clinical trial i.e., all phases of clinical trials.
ICH GUIDELINES FOR SAFETY NARRATIVES
The International Conference on Harmonization (ICH) tripartite guideline on the Structure and Content of Clinical Study Reports (CSRs) E3 (Section 12.3.2) provides brief information about the content of the safety narratives. All those adverse events that may affect the safety categorization of the drug must be included in the safety narratives. The events that are not related to the drug under investigation or due to comparator drug may either be described briefly or can be provided as listings to the Regulatory agencies.