Availability of data and materials
Cancer
CANCER
De-identified data will be made available to other researchers on request, subject to 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 poetic-icrctsu@icr.ac.uk. The ICR-CTSU supports the wider dissemination of information from the research it does, and increased cooperation between investigators. Trial data is collected, managed, stored, shared, and archived according to ICR-CTSU Standard Operating Procedures in order to ensure the enduring quality, integrity, and utility of the data. Formal requests for data sharing are considered in line with the Institute of Cancer Research Clinical Trials and Statistics Unit (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 allowed if proposed projects have a sound scientific or patient benefit rationale as agreed by the TMG and approved by the Trial Steering Committee as required. Restrictions relating to patient confidentiality and consent will be limited by aggregating and anonymising identifiable patient data. Additionally all indirect identifiers that might lead to deductive disclosures will be removed in line with Cancer Research UK Data Sharing Guidelines. Additional documents might be shared if approved by the TMG and Trial Steering Committee (eg., statistical analysis plan and informed consent form).