The final step in setting up a study to support a TrialKit can support any risk-based monitoring model is to define the rules.(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, what needs to be monitored. This step requires the TrialKit mobile appa study manager may want Monitors to verify specific data points that need review, but those requirements may vary by site or even by subject.
This article covers how to configure which fields require source level verification under a 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:
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To define a new rule, open an applicable subject record that will need to be monitored. Tap the workflow settings icon indicated below.
The ability to see this icon depends on your role's permission settings (Enable Risk-Based Monitoring Function )access to configure risk based monitoring from the study role security settings.
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As shown in the image 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)
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In the configuration above, monitoring will be required on the first three fields of the form for records with visit dates starting on March 24, 2018, for all subjects at one site for one visit.
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