---
title: "CDx Combined Study Governance Readiness Checklist | QbD Group"
description: "Free governance readiness checklist for pharma sponsors and diagnostic partners planning a combined CDx study in Europe. Check where the pharma-IVD responsibility gap remains open."
url: https://qbdgroup.com/en/cdx-governance-readiness
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"CDx Combined Study Governance Readiness Checklist | QbD Group\", https://qbdgroup.com/en/cdx-governance-readiness"
---

Combined Studies · Pharma & IVD Governance

# 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.

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## 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.

0 – 13 checked

### High governance risk

Key inter-organisational agreements are missing. A CDx Governance Alignment Session is strongly recommended before study initiation.

14 – 24 checked

### Moderate risk

Several gaps exist. Address these before your first EC submission - gaps found by reviewers take longer to fix than gaps found internally.

25 – 30 checked

### Well-aligned

Document remaining gaps and assign owners. Review at each major programme milestone.

0 of 30 checked

01

## IVDR Sponsorship and Regulatory Accountability

0 / 6

02

## EC and CA Submissions

0 / 5

03

## Study Site Oversight and Monitoring

0 / 7

04

## Safety Reporting

0 / 6

05

## Contractual Arrangements and the EU Legal Representative

0 / 6

## Want the Full Framework?

Download our whitepaper, *Collaborative Responsibilities in Combined Studies*, for the complete governance framework behind this checklist.

[Download the Whitepaper](https://qbdgroup.com/en/white-papers)

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Source: https://qbdgroup.com/en/cdx-governance-readiness — © QbD Group. Quote freely with attribution and a link back.