Ethical Approval

Ethical approval has been granted for this research study by the Cambridgeshire and Hertfordshire Research Ethics Committee.
REC: 21/EE/0204
IRAS: 301794
ISRCTN: 14748840

Trial Governance

Trial Steering Committee

The Trial Steering Committee is a group of independent experts, who meet at least once a year to provide advice and oversight of the programme, as well as ensuring the project is maintaining patient safety and adhering to protocol.

Trial Steering Group Members:
Chair: Dr Jonathan Evans
Clinician: Dr Geraldine Swift
Statistician: Prof Richard Emsley
Health Economics: Prof Sandy Tubeuf
PPI: Jennifer Bostock

Data Monitoring and Ethics Committee

The DMEC is made up of three independent experts. The role of the DMEC is to safeguard the interests of trial participants, monitor safety and monitor the overall conduct of the trial. The DMEC will receive and review information on the progress and accruing data of the trial and provide advice on the conduct of the trial to the Programme Steering Committee.

Data Monitoring and Ethics Committee Members:
Chair: Dr Alexandra Pitman
Clinician: Dr Tania Bugelli
Statistician: Prof John Norrie