Ethics approval and consent to participate
RECRUITMENT
The TRACC study was reviewed and approved by the London Westminster Research Ethics Committee REC No:15/LO/1576. The study is being conducted in compliance with the principles of the Declaration of Helsinki. A copy of the protocol, informed consent form, other written patient-facing information, and any proposed advertising material has been submitted to an independent ethics committee and written approval obtained. A copy of the written approval of the protocol and informed consent form was received by the sponsor before recruitment of patients into the study. Subsequent protocol amendments and changes to the informed consent document have also been submitted to the independent ethics committee and approval obtained. Written informed consent is taken from patient prior to any study procedures taking place. Data and samples from recruited patients will be handled strictly confidentially, being collected and stored anonymously. Each patient’s confidentiality will be maintained in compliance with the UK Data Protection Act of 2018.