• Clinical Study Reports E3

    Code Document Title Previously coded
    • E3 Q&As R1Questions & Answers: Structure and Content of Clinical Study Reports

      Finalised Q&As:
      July 2012

      E3 Questions and Answers (R1)
      Concept Paper
      Description:

      Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E3 Guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

      In July 2012, minor typographical errors were corrected in the Answer to Question 6 and the document was renamed R1.

      Implementation:

      Step 5

      EU:

      Transmission to CHMP and release for information, July 2012, issued as EMA/CHMP/ICH/435606/2012

      MHLW:

      Adopted 18 October 2012, PFSB/ELD Administrative Notice

      FDA:

      Posted on FDA website on 25 January 2013