None listed
Conditions
Brief summary
The primary aim of the study is to test and compare the two approaches of remote monitoring: Source data verification via uploading of documents and source data verification via live monitoring through a platform such as zoom. Based on the trial risk categorisation of BALANCE trial ( NCT 03005145) Australian national guidelines support the use of remote monitoring for this type of trial. The term remote monitoring describes monitoring activities that were previously conducted at the trial site by the trial monitor, but can now be conducted off-site (e.g., the review of documents sent by e-mail) (NHMRC guidelines on Risk-based management and monitoring of Clinical Trials involving therapeutic goods, 2018’) A key component of the monitoring is Source Data Verification (SDV), where the primary document is reviewed by a monitor for completeness and accuracy. There are three key approaches used for SDV. a) ‘Document up-load’ SDV where a site share requested documents through fax, email, upload into cloud-based file share system for review by the monitor at a later time b) ‘Live video’ SDV where the study monitor reviews and confirms source data in real-time over a video-link with the study site, c.) sites may facilitate a monitor’s direct access to their electronic medical record (EMR) allowing the monitor to directly locate and review source data. There isn’t sufficient literature to suggest the benefits of different remote monitoring approaches and also when and if one method should be preferred over the other. In this study, we aim to compare the two most commonly used approaches to SDV (document up-load and live video) and evaluate the effectiveness of both approaches.
Interventions
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 th
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 index blood 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 randomly for monitoring. Audit - Monitoring staff will be checking that the data entered on CRF by site staff matches the source documents. Monitoring staff as well as site staff will be required to fill out a worksheet each specifying the total time taken to complete the whole monitoring activity including the time taken to gather the source documents.
Sponsors
MONASH Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
all sites participating in BALALNCE trial in Australia (NCT03005145)(n=20) will be invited to participate in the study.
Exclusion criteria
Nil. Sites not willing to participate in the study will be excluded.
Outcome results
None listed