Confidentiality {27}
IPD
SECONDARY
All participants are assigned a study-specific identification number. Exported data are de-identified and stored separately from the data set containing participant identifying information (only the participant’s unique study number is contained in both files for the purpose of re-identification). eCRFs and any study information are stored on a password-protected computer or secure Griffith University applications accessible only by the research team. All paper copies of study information, including the signed participant consent forms, are stored in a locked cupboard, in a secure room, located at the hospital site where the data are collected. All collected paper-based data are securely stored for the duration of the trial and will be transferred to an electronic format, with paper-based/non-electronic data destroyed once the trial has ended. Re-identifiable electronic data will be securely stored indefinitely for scholarly priority (e.g. secondary analysis) and in accordance with the NHMRC Australian Code for the Responsible Conduct of Research and GCP. Individual participant data (IPD) is not shared outside of the research team as data collected may be potentially re-identifiable. This decision was made as IPD sharing may have discouraged potential participants from agreeing to participate if they were aware their data may be shared with others. De-identified electronic data (i.e. name, date of birth and hospital number removed) will be shared with members of the research team who are located at institutions outside of Australia.