Data Collection
In each study, data will be collected by trained staff under the supervision of the site principal investigator using a case report form and data dictionary. Data will be collected at baseline, from day 0-14 (blood tests, SpO2/FiO2 ratio, modified ordinal scale); on day 28 and day 60 (invasive mechanical ventilation status, vital status, discharge status). The detailed list of collected data items and the schedule for data collection are described in the individual study protocols.
De-identified individual patient data from each contributing study will be shared with the meta-trial executive committee under a signed data-sharing agreement and stored in a secure data collection platform, administered by the Australian National University. Electronic information will be kept on password protected computers accessible only to authorised personnel. All study material, including case report forms and the study database, will be stored for a minimum period of 15 years after the conclusion of the study or for a period as required by local laws and regulations. Any paper study material that requires disposal will be shredded using a commercial grade shredder or other means that preserves the confidentiality of participants. Any electronic data requiring disposal will be thoroughly erased from its electronic media. Each participating study will maintain a log of enrolled patients that includes patient identifiers. Patient identifiers are not transferred to the meta-trial coordinating centre, but it must be possible to reidentify patients by each participating study to allow future audit against source documents.