TrialKit 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, visit, or even by subject. subject.
TrialKit allows for RBM models to be implemented in a couple different ways
Real-time through the TrialKit API from an external tool driving the RBM decisions
A built-in configuration tool to define the RBM rules
...
This article covers how to configure which fields require source-level verification under a known risk-based monitoring model.
Rules for what needs to be monitored are easily defined directly from the CRFs in the study. This can be done on any CRF at any site depending on what rules are being defined. The options per rule are as follows:
...
Starting date
...
Distribution: Single participant, single site, all sites
...
Access to configure these rules requires two unique permissions
...
Access to risk based monitoring on its own will only allow users to view the existing rules. Configuring those rules and saving new ones is a separate permission.
To define a new rule, open an applicable subject record that will need to be monitored. Tap the workflow settings icon indicated below.
...
Tap the lock icons next to any of the fields on the form that need to be Monitored.
Green = enabled (Monitor will review).
Red = disabled (Monitor will not review)
...