​NHS England Data Sharing Audit: GRAIL Bio UK Ltd and Queen Mary University of London

Purpose

This report records the key findings of a remote data sharing audit of GRAIL Bio UK Ltd (GRAIL) between 22 and 25 June 2026. It provides an evaluation of how GRAIL, Queen Mary University of London (QMUL) and its Processors conform to the requirements of:

• the data sharing framework contract (DSFC)
  • CON-440011-T3F5R-v2.02 (GRAIL)
  • CON-315125-P6G9X-v2.02 (QMUL)
• the data sharing agreement (DSA) DARS-NIC-604847-S4B5L-v7.2
• the organisations’ own policies, processes and procedures

These DSAs cover the provision of the following datasets:

The Joint Controllers are GRAIL and QMUL and the Processors are Amazon Web Services UK, Amazon Web Services Inc, Arrow Business Communications Limited under brand name ARO and GRAIL Inc.

A new Multi-Cancer Early Detection (MCED) test has been developed that can detect many types of cancer from a single blood sample. This test is called Galleri (Registered Trademark). This trial aims to find out whether it is better at detecting cancer early, compared to other tests that the NHS currently uses. The purpose of NHS-Galleri is to demonstrate the clinical utility of the MCED blood test for individuals in a general screening population in a real world NHS setting. The rationale behind this trial is that MCED is a novel screening paradigm, and assessment of the use and impact of test results is necessary to enable integration into clinical practice. This will be the first randomised, double blind, controlled trial statistically powered to assess clinical utility of a MCED test.

The interviews during the audit were conducted through video conferencing.

This is an exception report based on the criteria expressed in the Data Sharing Audit Guide version 5

Audit type and scope

Data recipient’s acceptance statement

GRAIL and QMUL have reviewed this report and confirmed that it is accurate.

Data recipient’s action plan

GRAIL and QMUL will establish a corrective action plan to address the finding. The Audit Team will validate this plan and the resultant actions will be followed up with GRAIL and QMUL by the IG Risk and Assurance team at NHS England to confirm the findings have been satisfactorily addressed.

The Audit has identified 1 opportunity for improvement which is provided for reference only and will not be followed up.

The following table identifies the 1 observation raised as part of the audit.

The following table identifies 1 opportunity for improvement which could help an organisation improve its controls or processes.

Use of Data

GRAIL and QMUL confirmed that the datasets were only being processed and used for the purposes defined in the DSA and were not being linked with another dataset.

Data Location

GRAIL and QMUL confirmed that processing and storage locations, including disaster recovery and backups, of the datasets were limited to the location shown in the following table. These locations conform with the territory of use defined in section 2c of the DSA.

Back-up Retention

The duration for which data may be retained on backup media is:

The audit was based upon a sample of the data recipient’s activities, as observed by the Audit Team. The findings detailed in this audit report may not include all possible nonconformities which may exist. In addition, as the audit interviews were conducted through a video conference platform, certain controls that would normally be assessed whilst onsite could not be witnessed.

NHS England has prepared this audit report for its own purposes. As a result, NHS England does not assume any liability to any person or organisation for any loss or damage suffered or costs incurred by it arising out of, or in connection with, this report, however such loss or damage is caused. NHS England does not assume liability for any loss occasioned to any person or organisation acting or refraining from acting as a result of any information contained in this report.