Applicability · ICH E6(R3) · iFeed Regulations

Regulations/ICH E6(R3)/Applicability

/ Applicability logic

Applicability begins with scope, not assumption.

ICH E6(R3)

Applicability 01

Interventional trials

Core use case for regulatory reliance and GCP evidence.

Applicability 02

Sponsors and investigators

Both need evidence of responsibility, oversight, and participant protection.

Applicability 03

Service providers and CROs

Delegation requires documented responsibilities and oversight.

Applicability 04

Regional implementation

ICH Step 4 does not create identical legal effect everywhere on the same date.

/ Dates and gates

Timing changes what can be responsibly claimed.

status gates

Gates

Track these before publishing a checklist or readiness claim.

2025-01-06 Step 4 final · 2025-07-23 EMA EU effectiveness for principles/Annex 1 · regional implementation checks · Annex 2 draft watch · protocol quality design gate

/ Use cases

Regulated use cases need a decision record.

life sciences lens

Use case 01

Principles

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. Core GCP principles frame participant protection and reliable results.

Use case 02

Annex 1 final

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. The current final source gives operational expectations for interventional trial design and conduct.

Use case 03

Annex 2 draft/watch

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. Additional trial-design and data-governance topics remain watch items until finalised and regionally implemented.

Use case 04

Quality by design

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. Critical-to-quality factors should be identified and managed early.

Use case 05

Proportionate approach

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. Controls should match risks to participants and data reliability.

Use case 06

Sponsor oversight

Use this as a trigger for ICH E6(R3) applicability review, not as an automatic compliance conclusion. Delegation does not remove sponsor accountability.

Source anchors

Current public sources for ICH E6(R3).

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official ICH page