The Good Clinical Practices-DCT Working Group will develop a scalable, fit-for-purpose, risk-based GCP approach to Decentralized Clinical Trial processes. A Toolkit for Sponsors and CROs is planned to include GCP risks as part of the overall risk assessment, define critical to quality factors and related variables related to GCP, and to provide guidance on how to validate GCP computerized systems used to generate, collect, and process data in decentralized clinical studies. A Guide for Study Participants is also planned to include GCP aspects of Principal Investigator and Sponsor overview of the Participant involvement since most activities are remote by-design.
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