33% of ICH E6(R3) you already have
Australia NHMRC National Statement on Ethical Conduct in Human Research already covers about 33% of ICH E6(R3), leaving
6 of 9 controls as genuinely new work.
Already covered 3
Likely covered 0
New work 6
What is genuinely new work
Nothing in Australia NHMRC National Statement on Ethical Conduct in Human Research reaches these. This is the list to scope.
ICH-E6-Annex2-DecentralisedClinicalTrials-DCT-eConsent-Remote-WearablesICH E6(R3) Annex 2 - Decentralised Clinical Trial (DCT) Elements + eConsent + Remote Monitoring + Wearables + Real-World Evidence
ICH-E6-DataMgmt-ExternalData-EHRs-RealWorldData-Coord-FDA-EMAICH E6 Data Management + External Data + EHR + Real-World Data + Coordination FDA + EMA + PMDA + ICH Family
ICH-E6-EssentialDocs-TMF-eTMF-ArchiveRetention-ICH-Section8ICH E6 Section 8 - Essential Documents + Trial Master File (TMF) + eTMF + Archive + Retention
ICH-E6-IRB-IEC-EthicsCommittee-InformedConsent-VulnerableICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations
ICH-E6-Investigator-Qualifications-Resources-Communication-SafetyReportingICH E6 Section 4 - Investigator + Qualifications + Resources + Communication + Safety Reporting + Source Document Verification
ICH-E6-Protocol-IB-CSR-ClinicalStudyReport-AuthoringICH E6 Section 6 + 7 - Protocol + Investigator Brochure (IB) + Clinical Study Report (CSR) + Reporting
Show the 3 you already have
ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrityICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight
How this is calculated
Already covered means a mapping runs from a control in Australia NHMRC National Statement on Ethical Conduct in Human Research to that control. Likely
covered means no direct mapping exists but both frameworks map to the same control in a third
standard. New work means neither. We keep those separate rather than adding them into one
friendlier number, because blending them would present a two-hop inference as a verified
fact.
Coverage is not symmetric.
Run it the other way and you will get a
different number; both are correct.
From 332,959 cross-framework control
mappings across 723 frameworks, 531 of them verified against
their source documents. It does not tell you that you are compliant: a mapped control means
the two standards ask for the same thing, not that you have done it.
Try another pair ยท
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