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.