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Participant narratives can be defined as a summary or synopsis of the event that has occurred to a clinical trial participant. Narratives are provided for deaths, other serious adverse events, and other significant adverse events of interest. A narrative provides demographic information and important baseline characteristics, relevant medical history and previous/concomitant medications, the disease being treated, trial treatment exposure, a detailed version of the medical event that has occurred, what action was being taken after the event, a description if the event is in any way related to the trial treatment or not, and additional relevant information from the database (eg, laboratory test results/vital signs if deemed relevant) and other sources.
Emtex Life Science medical writers can help you with the document development process (eg, writing, circulating for review, and implementing comments) to ensure a well-structured document that is fit for purpose and meets the regulatory reviewer’s needs.