In January 2022, Health Canada announced the implementation of ICH E8(R1): General Considerations for Clinical Studies, a key reference for the design of clinical trials. This document:
(1) identifies the basic factors fundamental to the quality of clinical trials to ensure the protection of participants, the integrity of data, the relevance and reliability of results, and the achievement of objectives;
(2) addresses a wide variety of trial designs and data sources;
(3) provides cross-references to all other relevant ICH guidelines to be considered when planning clinical trials.
Investigators, especially those designing their own clinical studies, and their teams are encouraged to become familiar with this new guidance.
View this document here.