Issue Date: January 29, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E3 Structure and Content of Clinical Study Reports – Questions and Answers (R1)
Since the ICH E3 guidance was made final, experiences implementing the guidance in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to facilitate implementing the ICH E3 guidance by clarifying key issues.
Download the Guidance Document
