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.