Regulatory and ethical considerations
ICH
The trial will be conducted in compliance with the approved protocol, the Declaration of Helsinki 2008, the principles of Good Clinical Practice (GCP) as laid down by the ICH topic E6 (R2), Commission Clinical Trials Directive 2005/28/EC* with the implementation in national legislation in the UK by Statutory Instrument 2004/1031 and subsequent amendments, General Data Protection Regulation and the UK Data Protection Act 2018, and the UK Policy Framework for Health and Social Care Research.The Medicines and Healthcare Products Regulatory Agency (MHRA) granted Clinical Trials Authorisation on the 6th September 2021. The Westminster Research Ethics Committee granted ethical approval on 19th October 2021.