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ICSR – Patient Narratives

UpdatedFebruary 23, 2023

ICSR – Patient Narratives

An Individual Case Safety Report (ICSR) is a document that contains information about an adverse event or side effect experienced by a patient during a clinical trial or after the use of a medication or medical device. Patient narratives are an important component of an ICSR, as they provide a detailed account of the patient’s experience and help to contextualize the adverse event. Here are some key steps to follow when writing ICSR patient narratives:

  1. Collect relevant information: Begin by collecting all relevant information related to the patient, including their age, sex, medical history, and other relevant demographic information.
  2. Describe the adverse event: Provide a detailed description of the adverse event experienced by the patient, including the date of onset, duration, and severity.
  3. Provide context: Provide context for the adverse event, including any relevant medical or social factors that may have contributed to the event.
  4. Describe the patient’s response: Describe the patient’s response to the adverse event, including any treatment or interventions that were administered.
  5. Use clear and concise language: Use plain language and avoid technical jargon to ensure that the narrative is easy to understand.
  6. Follow regulatory requirements: Ensure that the narrative meets all regulatory requirements for ICSR reporting, including the use of standardized medical terminology and the inclusion of all relevant information.
  7. Obtain informed consent: Obtain informed consent from the patient or their legal representative before including their personal information in the ICSR.

Overall, writing ICSR – Patient Narratives requires careful attention to detail and a thorough understanding of the regulatory requirements for adverse event reporting. It is important to work closely with the study team, regulatory agencies, and other stakeholders to ensure that the patient narratives are accurate, complete, and effective in conveying the necessary information about adverse events experienced by patients.

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