Data availability statement
Cancer
CANCER
De-identified individual participant data, together with a data dictionary defining each field in the set, will be made available to other researchers on request, subject to the approval of a formal data access request in accordance with the ICR-CTSU data and sample access policy. Trial documentation including the protocol are available on request by contacting The ICR-CTSU supports the wider dissemination of information from the research it conducts, and increased cooperation between investigators. Trial data is collected, managed, stored, shared, and archived according to ICR-CTSU Standard Operating Procedures to ensure the enduring quality, integrity, and utility of the data. Formal requests for data sharing are considered in line with ICR-CTSU procedures, with due regard given to funder and sponsor guidelines. Requests are via a standard proforma describing the nature of the proposed research and extent of data requirements.Data recipients are required to enter a formal data sharing agreement, which describes the conditions for release and requirements for data transfer, storage, archiving, publication, and intellectual property. Requests are reviewed by the Trial Management Group (TMG) in terms of scientific merit and ethical considerations including patient consent. Data sharing is undertaken if proposed projects have a sound scientific or patient benefit rationale, as agreed by the TMG and approved by the TSC, as required.Restrictions relating to patient confidentiality and consent will be limited by aggregating and anonymizing identifiable patient data. In addition, all indirect identifiers that may lead to deductive disclosures will be removed in line with Cancer Research UK Data Sharing Guidelines. Additional documents may be shared if approved by the TMG and TSC, e.g., statistical analysis plan and informed consent form.