DATA MANAGEMENT TECHNOLOGY & The remote approach
Founded in 1999, Nubilaria is an information technology company with origins in design, management, and distribution of complex database systems and innovative IT services.
acting as study subjects. The oversight of these activities requires a study
C
monitor to travel to the clinical sites to control the validity and integrity of the clinical trial results. A large component of this on-site monitoring is the source data verification (SDV), which involves the comparison of case report form values against source data to verify that the reported data is accurate, complete and verifiable; confirms the trial is being conducted in compliance with protocol and good clinical practice (GCP); and ensures that appropriate regulatory requirements are being followed.
Monitoring activities should be digitalised The pandemic’s impact on the life sciences industry has spurred remote monitoring. And, while remote monitoring has already been used for a number of years, Covid-19 has acted as an accelerator, leading to the broad adoption of this approach. With rapidly developing technologies, remote
access to source data is an option that is increasingly discussed as an alternative to on-site monitoring. Some of the key pre-conditions to this include: remote monitoring – including remote SDV and source data review (SDR) – must not be an added burden to sites
remote SDV and SDR via direct medical records access should be made possible with the explicit approval from relevant authorities; however, data protection issues may pose serious problems with this approach.
The weaknesses of on-site monitoring will lead
to more remote SDV (rSDV) as there are more advantages of remote monitoring/rSDV over traditional SDV; for example, increased accuracy, reduced time-to-submission, more focus to enhanced CRA activities and higher cost-savings. The ACTide sourceBOX is a secure shared file area (SSFA) or a shared stream channel (SSC) platform,
60 | Outsourcing in Clinical Trials Handbook
linical trial monitoring is a critical part of any clinical trial. It helps study sponsors gauge the progress of their study and protect those
which provides a secure place to redact and upload documents for study coordinators, and remotely review and upload their own monitoring reports to monitors. ACTide sourceBOX makes remote source data verification (rSDV) feasible.
++ Site Personnel
BYOD Approach
+
1HZ 7DE
1HZ 7DE
ACTide sourceBOX sourceBOX eCRF eCRF
Monitoring Tools
Monitoring Tools
Report Verify/Review Report Verify/Review Compare Compare CRA / Remote Monitor SDV flag
SDV flag
The ACTide sourceBOX workflow.
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