Clinical Studio can support any risk-based monitoring (RBM) models that are created outside the system in analytical or biostatistics reporting. This takes Field Source Verification to a more site/subject-specific level, rather than applying the same rules throughout an entire study. In other words, a study manager may want Monitors to verify specific data points that need review, but those requirements may vary by site or even by subject.
The functionality described in this section will only apply to studies using RBM. To manage the rules behind what needs to be monitored, Clinical Studio utilizes its sister platform TrialKit to make it significantly easier to define rules. Monitoring, on the other hand, can still be done from either Clinical Studio or the TrialKit app.
The following steps walk through how RBM is applied and managed.
1. Enable RBM
2. Define Rules