Rules for what needs to be Monitored is 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. Multiple rules can be defined. The options per rule are as follows:
- Starting date
- Distribution: Single participant, single site, all sites
- Single visit or all visits where the form exists
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 (discussed here).
As shown in the image below:
1. 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)
2. Once the desired fields are set, tap the icon in the upper right corner. This is where the rule will be defined and saved.
To define and save the new rule, indicate a starting date and which forms the rule will apply to, and then define which subject and record(s) the rule is for.
Note: The starting date for the rule is compared to the visit/transaction date on the form, not the current date when Monitoring takes place.
The following are the rules that can be applied:
- All participants in the study
- All participants at the current site only
- Just the participant currently open
- All visits where the current form is collected
- Only the record that is currently open
To edit an existing rule, tap it in the Existing configurations table and change any of the parameters listed above. Then tap Save.
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.