Clinical study Report

A clinical study report (CSR) is one of many types of regulatory documents that comprise a marketing application for a drug, biologic, or device. A CSR is a descriptive account of a single clinical trial accompanied by tables, listings, and figures (TLFs) displaying all study data and results. CSR presents a story of clinical trial

  • What was planned?
  • What was changed and why?
  • What actually happened?
  • What was found?