An Individual Case Study Report (ICSR) is a safety service document which includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product. It is an important facet of adverse event reporting which is a source of data in PV (pharmacovigilance). The ICSR is most commonly associated with PV. To build a compliant ICSR, there are four elements which must be mentioned:

  • A diagnosed patient
  • A reporter
  • A suspect drug
  • An adverse event

Adverse event reporting is a Regulatory requirement in most of the countries for pharmaceutical companies. It also provides data to the companies and drug Regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The source of adverse event reports may include reports from:

  • Healthcare professionals or patients
  • Patient support programs
  • Clinical or post-marketing studies
  • Literature sources
  • Media including websites
  • Or, reported to drug Regulatory authorities themselves

The implementation of ICSR varies from drug to drug. The applicant must reach out to the Regulatory agency before submitting the reports to clarify the content of ICSR. More details about the content and guidance document of ICSR is available on the websites of the agencies.

Freyr’s expertise in handling various ICSRs and AERs can help you stay compliant with the norms of the agencies. To know more about creation, publishing and submission of ICSR, contact our experts at