Navigate to a completed CRF that uses FLSV at the Proper Review Level
Bring up a subject record in a form that uses FLSV at the proper Review Level. That means if the second review level uses FLSV, then you must bring up a form that has completed the first review level. If you do not, you will not be able to configure RBM
Which subject matters also. It matters because you may want to define RBM for an entire site. In order to do that, you must have a subject that belongs to that site.
You will not be able to configure RBM if you are not at the correct review level that uses FLSV.
Enter RBM Configuration Mode
Once you have navigated to a completed CRF, to decide which fields need to be source verified, you must first enter RBM Configuration Mode. You will know that you are in RBM Configuration mode by pressing the RBM Configuration Icon and noticing that the Form Status is telling you that you have entered RBM Configuration Mode. You will also notice that each field has a lock icon located immediately to it’s left that is either red or green.
The lock icons are how you will define the fields that need source verification. If your form has not already been defined for RBM, the status of each icon will default to the form’s FLSV configuration which was defined in the Form Builder.
Green locks represent a field that will be source verified. Red locks represent a field that will NOT be source verified. To change the status of a field, simply tap it. That will change the color of the field lock as well.
Once you have the configuration set, the next step is to decide which subjects in the site/population will have this form source verified in this way.
Apply RBM to Participant, Site or Population
Notice the upper right corner of the screen above. That is the Action icon. In this case, the Action is to apply the RBM model to some subset of the population for the current form. The following screen appears when you tap the Action icon:
This screen allows you to either select an existing configuration or create a brand new configuration. The configuration will tell the system how to apply the RBM model that you tapped out on the form in the previous section.
Tapping on an Existing RBM Configuration table row will populate the fields below the table. By tapping save, the RBM model will be applied to that configuration.
Here is an explanation for the 3 fields, this is very important:
RBM Configuration Starting Date
All participants will use the RBM model starting on or after the configuration date. If a participant has a form visit date that is greater than or equal to this date field, they will be included. That inclusion depends, however, on a combination of all three fields.
Use Configuration for the Following
This is where you decide which participants will use this configuration. Of course, their visit date must come on or after the RBM Configuration Starting Date. This allows you to select just the participant that you loaded, all participants in the current site, or all participants in the study.
User Configuration For
Because forms can occur at multiple visit intervals, as log forms or unscheduled visits (or all of the above), you can apply the RBM model to This Visit or All Visits where this form occurs in the context of the other fields.