ICH E6(R3): every control, and what you already have

9 controls 111 frameworks share controls with it International (ICH) verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

ICH E6 Good Clinical Practice Evidence & Implementation Kit

9 controls is the documentation set somebody has to write. This is that set, already written: an adopt-ready artifact for every control in policy and procedure text you edit rather than draft, and the evidence checklist an auditor asks for against each.

See what is in it, $249

The same set every buyer of this kit receives. Nothing here is produced on request.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
EU Clinical Trials Regulation (CTR 536/2014)	7	measure it →
FDA Quality Management System Regulation (QMSR)	5	measure it →
Florida Digital Bill of Rights (FDBR)	5	measure it →
GAMP 5	4	measure it →
IEC 60601-1	4	measure it →
TEFCA	4	measure it →
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)	3	measure it →
AS9100D	3	measure it →
Australia NHMRC National Statement on Ethical Conduct in Human Research	3	measure it →
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)	3	measure it →
Barbados Data Protection Act 2019	3	measure it →
COSO Internal Control	3	measure it →

Every control

Code	Control	Also in
`ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrity`	ICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity	55
`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	7
`ICH-E6-DataMgmt-ExternalData-EHRs-RealWorldData-Coord-FDA-EMA`	ICH E6 Data Management + External Data + EHR + Real-World Data + Coordination FDA + EMA + PMDA + ICH Family	0
`ICH-E6-EssentialDocs-TMF-eTMF-ArchiveRetention-ICH-Section8`	ICH E6 Section 8 - Essential Documents + Trial Master File (TMF) + eTMF + Archive + Retention	8
`ICH-E6-IRB-IEC-EthicsCommittee-InformedConsent-Vulnerable`	ICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations	1
`ICH-E6-Investigator-Qualifications-Resources-Communication-SafetyReporting`	ICH E6 Section 4 - Investigator + Qualifications + Resources + Communication + Safety Reporting + Source Document Verification	1
`ICH-E6-Protocol-IB-CSR-ClinicalStudyReport-Authoring`	ICH E6 Section 6 + 7 - Protocol + Investigator Brochure (IB) + Clinical Study Report (CSR) + Reporting	1
`ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinical`	ICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation	83
`ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-Vendor`	ICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight	42

Tell me when ICH E6(R3) files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What this page is

A control-level reference for ICH E6(R3), drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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