Data management {19}
toxicity, Cancer
CANCER
Respiratory data (‘Breathe Well’ and RPM/RGSC), CT images, MV frames from during the irradiation, and demographic information will be collected from the subjects. At the randomisation stage of the study, patients will receive a trial ID. The data saved for the trial will be under this de-identified trial ID. A separate key of the subject study number and their medical record number will be securely stored by the chief investigator to allow re-identification if necessary. This master list for re-identification will remain at the Royal North Shore Hospital. Only the principal investigator will have the ability to re-identify subjects. Questionnaire and toxicity information will be entered in REDCap and collated information transferred to the same secure drive at the University of Sydney for storage. The data will be stored for 15 years as per clinical trial guidelines. Data sent from the Northern Sydney Cancer Centre, Royal North Shore Hospital in accordance with the study site’s ethics and security allowances and protocols to the study site University of Sydney will be anonymised but re-identifiable. Patient data could be made re-identifiable to obtain additional clinical information for the data analysis stage of the project, but only by the principal investigator. The de-identified data will be stored at the University of Sydney on a secure, password-protected backed-up database that will be created, much the same as what we have designed for previous University of Sydney studies.