Data management {19}
Data are entered directly into REDCap (Research Electronic Data Capture), via a secure web platform for building and managing online databases, by ResNs using a password-protected iPad. The eCRF was adapted from the paper version used in our pilot trial [The data management plan for data that will be retained on completion of the trial is as follows:All data retained will be in an electronic, re-identifiable format (i.e. stored separately from participant identifying information, with only participants’ unique study number documented in both datasets)Paper-based/non-electronic data (e.g. data collection instruments and research materials such as PICFs) will be transferred to an electronic format, and all paper-based/non-electronic data destroyedElectronic data (including re-identifiable raw data sets exported from REDCap, electronic photographs, and research materials such as PICFs) will be securely stored using password-protected computers and/or using Griffith University’s secure cloud storage systems. These data will be stored indefinitely for potential future research use by the research team (in accordance with the NHMRC Australian Code for Responsible Conduct of Research)Data management plans can be accessed by team members of the CTC and ResNs via the trial protocol and SOP.