• Clinical Study Reports E3

    Code Document Title Previously coded
    • Finalised Guideline:
      November 1995

      Description:

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. This document describes the format and content of a study report that will be acceptable in all three ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available but will not be submitted in all cases.

      Implementation:

      Step 5

      EU:

      Adopted by CPMP, December 1995, issued as CPMP/ICH/137/95

      MHLW:

      Adopted May 1996, PAB/PCD Notification No. 335

      FDA:

      Published in the Federal Register, 17 July 1996, Vol. 61, p. 37320