Site Readiness Under E6(R3)

Key expectations for site readiness under ICH E6(R3), including documentation, risk-based oversight, and digital data governance.

Site Readiness Under E6(R3)

Key expectations for site readiness under ICH E6(R3), including documentation, risk-based oversight, and digital data governance.

Site Readiness Under ICH E6(R3): Collaborative Accountability

E6(R3) strengthens the shared responsibility between sponsors and sites. Where E6(R2) left room for interpretation, E6(R3) provides clearer expectations for:

Qualified, documented personnel
Transparent task delegation
Data integrity through digital traceability
Shared monitoring responsibilities

What Changes in Practice?

Area

Expectation

Practical Adjustment

Training & Role Qualification

Training and delegation must be documented

Keep a real-time delegation log and training binder (digital preferred)

Data Governance

Traceable, auditable records are required

Ensure systems have audit trails and version control

Monitoring Collaboration

Oversight is shared

Participate actively in central monitoring reviews

IP & Digital Tools

Electronic processes must be validated

Confirm validation with sponsor or vendor, especially for eConsent or eSource

Bottom Line

Sites are not expected to do more, but to show clarity, traceability, and readiness. The focus shifts from completing tasks to demonstrating control.

Site Readiness Checklist Infographic

The MyRBQM® Portal allows sponsors to align site engagement, monitoring signals, and issue handling — improving readiness without adding burden.

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