Narratives

A narrative can be defined as a summary or synopsis of the event that has occurred to a subject participating in the clinical trial. A CIOMS report can be cited as an example of a narrative which provides valuable information about the occurrence of the event. The writing style of the narrative should be in a prescribed format. The narrative must mention the subject ID of the patient, ethnicity and medical history of the patient, the reason why the study treatment is being given to be subject, a detailed version of the medical event that has occurred, what action was being taken after the event, a description if the event is any way related to the study drug or otherwise and a list of all vital signs of the subject. If there is any other notion being considered important by the delegate or the Principal Investigator writing the narrative, it should find a mention in the narrative as well.