A study to compare two different approaches used for remote monitoring of a clinical trial

INTERVENTION: Sites participating in BALANCE trial will be asked to participate in one of the two approaches used for remote monitoring. Participating sites will either have to upload the documents on a shared drive or show documents on an online platform such as zoom. Monitoring approach where sites have to upload the documents on a shared drive is considered a standard arm of the trial. Monitoring via online platform such as zoom is the intervention arm. Site staff will be contacted beforehand to inform that they have been randomised to intervention arm where they would be required to participate in monitoring via zoom platform. Staff will have to gather source documents such as discharge summary, medication chart, pathology results to verify the inde Xblood culture for which the patient was enrolled in BALANCE trial (NCT03005145). Zoom sessions will be one one one session with the monitor and site staff. There will not be a need to record the sessions. Site staff will be asked to show the source documents on live camera and monitoring staff will verify that the data recorded on CRF (case report form) matches with source documents. Anticipated duration of monitoring session would be 1.5 hours with additional second or third meeting, if required. As all patients data would be different, it is difficult to give an exact time limit. We aim to monitor two patients in 1.5 hours, however, additional meetings with the site staff will be organised as needed. Site staff will be given enough notice before the meeting so that they can gather all required source documents. BALANCE trial has finished recruitment and we aim to monitor 10 per cent of the patients. Therefore, it will be a one time monitoring instead of regular monitoring. However, study numbers will be chosen ran CONDITION: Bacteremia; ; Bacteremia Infection ‐ Studies of infection and infectious agents Public Health ‐ Health service research PRIMARY OUTCOME: To evaluate the time taken by the monitor and by the site staff to complete monitoring using two different approaches. Site staff and monitoring staff each will have to complete a separate worksheet. Site staff will have to answer the total time taken to complete an activity such as the time taken to gather source documents.[At the end of monitoring activity for the site] INCLUSION CRITERIA: all sites participating in BALALNCE trial in Australia (NCT03005145)(n=20) will be invited to participate in the study. SECONDARY OUTCOME: Number of source documents/platforms accessed to complete SDV components, ; Method: This will be captured as per the survey in appendi X1 of the protocol. [At the end of each monitoring.] To compare the acceptability and user preference of two approaches. The acceptability and user preference will be assessed as a composite outcome. ; Methods: User preference and acceptability both will be assessed using a survey as per appendi X1 in attached protocol. ; [At the end of monitoring activity at each site] To compare the quality of monitoring the two approaches. ; Method: quality of monitoring will be assessed using the answers from the worksheet completed by the site staff and monitoring staff. The specific question related to how many errors were corrected on CRF relates to the quality of the monitoring approach. Please see the worksheets attached. [At the end of monitoring of each patient] To evaluate the time taken by site staff and monitoring staff to complete the monitoring activity. ; Method: the questions related to time will be captured on the worksheet completed by site staff and monitoring staff.[At the end of monitoring]