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ICH E6 (R3) Good Clinical Practice for Digital & Decentralized Trials

Data governance, computerized systems validation, digital health technologies, and investigator oversight in clinical trials.

Executive Overview

ICH E6 (R3) represents the fundamental modernization of Good Clinical Practice (GCP) guidelines by the International Council for Harmonisation, formalizing governance for decentralized clinical trials (DCT), electronic source records (eSource), wearables, and AI data pipelines.

1. Electronic Systems Governance & Data Lifecycle

ICH E6 (R3) replaces rigid paper-based validation with risk-proportional technology governance:

  • Fit-for-Purpose Systems: Computerized systems used in trials must be validated proportional to the risk to participant safety and reliability of trial results.
  • Audit Trail Integrity: Immutable, time-stamped capture of all participant data creation, modification, and deletion events without obscuring original entries.
  • Decentralized Data Streams: Validated direct capture from wearables, ePRO/eCOA mobile apps, and telemedicine portals into electronic data capture (EDC).

Frequently Asked Questions

How does ICH E6 (R3) impact mobile app deployment in clinical trials?

It permits Bring Your Own Device (BYOD) clinical mobile apps provided the software enforces end-to-end encryption, local tamper-evident caching, and verifiable participant authentication.

AI Summary

ICH E6 (R3) represents the fundamental modernization of Good Clinical Practice (GCP) guidelines by the International Council for Harmonisation, formalizing governance for decentralized clinical trials (DCT), electronic source records (eSource), wearables, and AI data pipelines.