21 August 2018

The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1) Addendum, and is intended to support the scientific community in the comprehension of a new framework to define estimands based on the trial objective and considering intercurrent events. The training material is accompanied by examples and case studies.

Please find on the E9(R1) page the Training Material for download.