6. Module 5 Clinical study reports

Module 5: This module includes the clinical data for the analysis of the benefit-risk balance (efficacy and safety) of the product and should include the results of the studies performed in humans.

Module 5:

  • presents the clinical study reports (CSRs).
  • structure and content are specified in the ICH M4E guidelines, which provide a specific placement of clinical study reports and related information to simplify preparation and review and to ensure completeness.
  • main headings:
    • 5.1 Table of contents of Module 5
    • 5.2 Tabular listing of all clinical studies
    • 5.3 Clinical study reports
      • 5.3.1 Reports of biopharmaceutic studies
      • 5.3.2 Reports of studies pertinent to pharmacokinetics using human biomaterials
      • 5.3.3 Reports of human pharmacokinetic (PK) studies
      • 5.3.4 Reports of human pharmacodynamic (PD) studies
      • 5.3.5 Reports of efficacy and safety studies
      • 5.3.6 Reports of post-marketing experience
      • 5.3.7 Case report forms and individual patient listings
  • 5.4 Literature references