Data Collection
Data will be collected by trained staff at each site 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 provided in the individual study protocols.
Where paper records are used, they will be stored in locked rooms accessible only to authorised personnel. 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 centre will maintain a log of enrolled patients that includes patient identifiers. Patient identifiers are not transferred to the study coordinating centres, nor to the meta-trial coordinating centre, but it must be possible to reidentify patients by each participating centre to allow future audit against source documents.