---
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 and diagnostic partners planning a combined study in Europe - the 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.

GDPR Compliant

No Spam Guarantee

## Why Use This Checklist?

In combined studies, most delays occur when responsibilities fall between organisations because each party assumes the other owns them. 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 both organisations involved in the study 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 & Regulatory Accountability

0 / 6

02

## EC and CA Submissions

0 / 5

03

## Study Site Oversight & Monitoring

0 / 7

04

## Safety Reporting

0 / 6

05

## Contractual & EU Legal Representative Arrangements

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)

---

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