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When ICH releases ICH E6 (R3) in Fall 2021 it will be composed of an overarching principles document (draft version) in addition to Annex 1 (addressing interventional clinical trials), and Annex 2 (providing any needed additional considerations for non-traditional interventional clinical trials). The overarching principles document and Annex 1 will replace the current ICH E6 (R2). When reflecting upon the early draft, one of the most significant messages is the alignment with ICH E8 (R1) in relationship to Quality by Design principals. This article investigates the core interaction between the application of technology with Quality by Design principles, and how without the contribution of technology, patient participation and oversight activities in decentralized trial environments would not be possible. |
