ICH E6(R3) - Good Clinical Practice
ICH E6 Annex 2 - Decentralised Elements

ICH E6(R3) - Good Clinical Practice ICH-E6-Annex2-DecentralisedClinicalTrials-DCT-eConsent-Remote-Wearables: ICH E6(R3) Annex 2 - Decentralised Clinical Trial (DCT) Elements + eConsent + Remote Monitoring + Wearables + Real-World Evidence

ICH E6(R3) Annex 2 (Use of Decentralised Elements in Clinical Trials) is the new section establishing principles for decentralised clinical trial (DCT) elements - reflecting COVID-19 acceleration + technology enablement + patient-centric trial design. Decentralised elements: remote participant identification + recruitment + screening; eConsent + remote consent + multimedia + comprehension verification; remote/home-based study procedures + nurse visits; direct-to-patient supply (investigational product shipment to home); remote monitoring + visit substitution + ePRO + telemedicine; wearable devices + sensors + continuous data collection; eSource + EHR integration + real-world data; remote source document verification + investigator oversight + risk-based approach. R3 emphasises: investigator oversight + accountability remains + protocol design considers DCT element risks + benefits + scientific validity + participant safety; regulatory pre-discussion advisable; vendor management for DCT-enabling technology + qualification + data integrity. eConsent: validated platform + electronic signature + identity verification + 21 CFR Part 11 + EU CTR; remote consent considerations (privacy + connectivity + family member presence); withdrawal mechanism. Remote monitoring: central + risk-based + statistical + on-site as triggered; sponsor + CRO oversight; investigator visibility. Wearables: vendor qualification + data integrity + ALCOA+ alignment + FDA Software as Medical Device (SaMD) + EMA + algorithm validation + clinical evidence. Real-World Evidence (RWE): EHR data + claims + registries + patient-generated; FDA + EMA RWE guidance + use for hybrid + synthetic control arms; ICH E20 (Adaptive Designs) integration. Coordinates with FDA Decentralised Clinical Trial Guidance + EMA Decentralised Clinical Trials Q&A + Health Canada + PMDA + 21 CFR Part 11 + ALCOA+ + WHO. ICH E6 + Annex 2 + DCT + eConsent + Wearables + RWE applies.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 16 controls across 8 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Aged Care Quality Standards 2019 (repealed edition) · 3 controls

  • ACQS-3-1 Safe and Effective Care
  • ACQS-8-2 Clinical Governance
  • ACQS-8-4 Risk Management

HITECH Act · 3 controls

  • HITECH-Coord-HIPAA-Privacy-Security-Cures-ONC HITECH Coordination with HIPAA Privacy Rule + HIPAA Security Rule (Verified Separately) + 21st Century Cures Act + ONC
  • HITECH-Enforcement-CMP-Tiers-StateAGs-OCR HITECH 4-Tier Civil Monetary Penalty Structure, State AGs Enforcement and HHS OCR Settlements
  • HITECH-SubtitleD-Breach-Notification-BA-Direct-Liability HITECH Subtitle D - Breach Notification Rule (45 CFR Part 164 Subpart D), Business Associate Direct Liability, Subcontractors

COSO Internal Control - Integrated Framework (2013) · 2 controls

  • CA-10 Selects and Develops Control Activities
  • CA-12 Deploys Through Policies and Procedures

FDA Quality Management System Regulation (QMSR) · 2 controls

  • QMSR-820.10 Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
  • QMSR-ISO13485-Sec7_DesignControls Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)

TEFCA - Trusted Exchange Framework and Common Agreement · 2 controls

  • TEFCAREC-1 Common Agreement Conformance and Onboarding
  • TEFCAREC-2 Privacy, Security, Minimum Necessary

Florida Digital Bill of Rights (FDBR) · 1 control

  • FDBR-Scope-Defs Scope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)

GAMP 5 - Good Automated Manufacturing Practice · 1 control

  • GAMP5-Risk-CriticalThinking Risk-Based Approach, Critical Thinking and 5 Key Concepts

IEC 60601-1 - Medical Electrical Equipment Safety · 1 control

  • 60601-1.12 Accuracy of controls and instruments

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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The graph holds this control, the 16 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll ICH E6(R3) - Good Clinical Practice controls