Have You Closed the Pharma–IVD Responsibility Gap Before Your Study Starts?
A governance readiness self-assessment for pharma sponsors and diagnostic partners planning a combined CDx study in Europe - the CDx Combined Study Governance Readiness Checklist.
Important: This checklist provides a non-binding, informational governance self-assessment only. It does not constitute regulatory or legal advice.
Why Use This Checklist?
In combined studies, most delays come from responsibilities that neither organisation assumed were theirs. This checklist makes those assumptions visible before your first submission.
Sponsorship Clarity
Confirm who holds IVDR performance study sponsorship, and whether that's documented and agreed between pharma and the diagnostic partner.
Submission Alignment
Check that pharma RA and IVD RA are aligned on the combined EC/CA submission narrative before drafting begins.
Site & Safety Oversight
Verify that every study site - clinical, test, and sample collection - is covered by a monitoring plan, and that assay-related adverse events have a clear escalation path.
How to Use This Checklist
Work through the 30 items across 5 governance areas with your CDx partner - the pharma team and the diagnostic partner - before your first EC submission. Each unchecked item is a governance risk. Check off every item that's true today; your score updates live as you go.
High governance risk
Key inter-organisational agreements are missing. A CDx Governance Alignment Session is strongly recommended before study initiation.
Moderate risk
Several gaps exist. Address these before your first EC submission - gaps found by reviewers take longer to fix than gaps found internally.
Well-aligned
Document remaining gaps and assign owners. Review at each major programme milestone.
IVDR Sponsorship and Regulatory Accountability
EC and CA Submissions
Study Site Oversight and Monitoring
Safety Reporting
Contractual Arrangements and the EU Legal Representative
Want the Full Framework?
Download our whitepaper, Collaborative Responsibilities in Combined Studies, for the complete governance framework behind this checklist.
Download the Whitepaper