Readiness becomes visible through records.
ICH E6(R3)Critical-to-quality factor log
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Risk assessment and mitigation plan
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Protocol quality design rationale
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Sponsor oversight plan
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Vendor/service-provider oversight file
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Investigator responsibility evidence
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Data governance plan
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Computerized-system validation evidence
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Monitoring strategy
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Issue escalation and CAPA record
Keep this as a named evidence object for ICH E6(R3): source basis, owner, status, review question, and update trigger should be visible before reuse.
Each object needs review before reuse.
question bankCritical-to-quality factor log
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Risk assessment and mitigation plan
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Protocol quality design rationale
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Sponsor oversight plan
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Vendor/service-provider oversight file
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Investigator responsibility evidence
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Data governance plan
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Computerized-system validation evidence
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Current public sources for ICH E6(R3).
official firstThese links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.
ICH Efficacy Guidelines page
Current · Official landing page for ICH efficacy guidelines including E6(R3).
ICH E6(R3) Step 4 final guideline
2025-01-06 · Final Step 4 guideline text for principles and Annex 1.
EMA ICH E6 scientific guideline page
2025-07-23 · EU regional implementation context for ICH E6(R3) Principles and Annex 1.
ICH E6(R3) Annex 2 draft
2024-11-06 · Draft Annex 2 source. Treat as watch item, not final implemented requirement.