The updated ICH E6(R3) guideline reframes how sponsors are expected to demonstrate oversight in clinical trials. While the principles of Good Clinical Practice (GCP) remain unchanged, the approach to ensuring quality has shifted — from reactive issue correction toward proactive, risk-based oversight.
In practice, this means sponsors are no longer just responsible for trial setup and vendor selection. They must now actively manage quality across the entire study lifecycle, using structured risk assessment, centralized monitoring, and traceable decision-making. ICH E6(R3) shifts oversight from “find problems after they occur” to “design to prevent them.”
Modern trials are complex: multi-country, multi-system, decentralized, and data-intensive. Traditional monitoring alone cannot reliably safeguard study integrity.
ICH E6(R3) responds to this reality, emphasizing:
This evolution aligns with both ICH E8(R1) and regulatory expectations in the US, EU, and APAC.
Sponsors remain accountable for ensuring the study is designed, conducted, recorded, and reported in accordance with GCP — even when operational tasks are outsourced.
Sponsors must identify Critical-to-Quality (CtQ) factors early, including:
These QbD elements then shape the monitoring strategy, not the other way around.
Sponsors must implement systems that:
This is where RBQM replaces traditional SDV-heavy workflows.
E6(R3) requires risk management decisions to be:
The expectation is not just action, but transparent reasoning.
Sponsors who already use RBQM platforms are well-positioned for E6(R3) — very little conceptual change is required, only process clarity and governance.
Revisit your oversight SOPs: Ensure they explicitly reflect E6(R3) language.
Define CtQ factors at protocol level: Align ClinOps, Medical, Data, and QA.
Establish a cross-functional oversight meeting rhythm: Monthly or bi-weekly.
Document decisions with rationale: Replace status updates with traceable actions.
Apply centralized monitoring early: Focus on early data variation signals.
This ensures both compliance readiness and operational efficiency.
Delegation does not transfer responsibility.
CROs perform tasks; sponsors retain accountability.
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ICH E6(R3) does not add new burdens — it clarifies expectations. The sponsor’s role remains what it has always been: to ensure quality. What changes is how quality is demonstrated — through risk-based, data-driven oversight and traceable decision-making.
Sponsors who modernize these processes early will not only meet regulatory expectations, but also deliver faster, more predictable, and more reliable trial outcomes.
A one-page summary of the key oversight expectations in ICH E6(R3) — including what must be documented, how to structure decision traceability, and where RBQM fits in modern GCP operations.
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