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ICH E6(R3) Sponsor
Readiness Checklist

Six priority actions every clinical trial sponsor should take in 2026 to align with the new GCP guideline. Based on ACRO's 2025 RBQM Landscape Survey data and regulatory analysis.

Six actionable compliance items with regulatory references

Key actions for each item — specific steps, not vague guidance

Print-ready PDF with branded layout and space for notes

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96%

of trials now include RBQM components

ACRO 2025

82%

of large studies still use 100% SDR

ACRO 2025

30%

still default to 100% SDV

ACRO 2025

What's in the Checklist

Six priority actions based on the current state of E6(R3) adoption, drawn from the ACRO 2025 RBQM Landscape Survey and regulatory analysis.

Conduct a Gap Assessment Against E6(R3) Requirements

Map current processes against E6(R3) Principles and Annex 1. Identify gaps in computerized system oversight, data governance, and RBQM.

E6(R3) Principles & Annex 1

Audit Your Computerized Systems Inventory

Document each system's purpose, validation status, access controls, and management responsibilities.

Annex 1 §3

Revise Your Monitoring Strategy

Move from default 100% SDV/SDR to risk-proportionate monitoring with centralized statistical monitoring.

Annex 1 §6

Update SOPs and Training Programs

Revise internal procedures for data lifecycle controls, electronic signatures, and system validation.

Annex 1 §2

Establish Vendor Oversight Governance

Expand oversight beyond CROs to all service providers with defined KPIs and escalation pathways.

Annex 1 §5

Implement Quality by Design in Protocol Development

Integrate CtQ factor identification using structured risk assessment frameworks (RACT, FMEA).

Principle 6 & E8(R1)

Why This Matters Now

Despite 96% RBQM adoption, ACRO's data reveals that 82% of large studies still default to 100% SDR and 30% still use 100% SDV. The gap between regulatory expectation and operational reality is where compliance risk lives. This checklist targets the six highest-impact areas where sponsors can close that gap.

Built for Clinical Operations Leaders

This checklist is designed for VPs of Clinical Operations, Heads of Quality, and RBQM Program Leads who need to translate E6(R3) requirements into actionable compliance plans. It's not a regulatory summary — it's a prioritized action list based on where the industry actually stands today.

Data-Driven Priorities

Actions ranked by gap severity using ACRO's 3,758-study dataset

Regulatory References

Each item maps to specific E6(R3) Principles and Annex 1 sections

Print-Ready Format

Branded PDF with checkboxes, notes section, and space for team annotations