Having robust information on study visit windows and scheduled activities that is easily configurable (and reconfigurable as need be) is an important requirement when vetting IRT (IVR/IWR) systems for clinical trials. What kind of information should you look for?
First, there are the basics: scheduled activities, activity windows, and options for window enforcement. Here’s a project example from our VLIRT® system:
Hard enforcement of start and end dates requires users to stop and seek further guidance; soft enforcement provides a warning but allows the recording of an activity to proceed. The numbers above indicate the number of days between each scheduled visit and an ‘anchor’ visit (e.g., the randomizaton visit in the above example) – including the optimal target days, and the start, end, and past due dates for each activity window. System tables like these can also drive alerts and warnings for users – for example, color coding in a companion subject table which shows where in the window for next activity each subject currently lies.
System configurations should also address the more complex logistical issues that can apply to activities in a clinical trial. Here’s another example from our VLIRT® system:
The properties of each activity are easily manipulated via configuration tables like these. For instance, “Is Final = True”, as seen above for an unblinding, means no other activity is permitted for the subject once he/she has been unblinded (other than additional unblindings, of course). A property of ‘Is Final = False” means additional study activity can be permitted to occur after an unblinding activity is recorded.
Other status indicators can address whether drug is assigned at the visit, whether the activity date can be edited (by site staff), how to handle predictive resupply algorithms at the activity level, whether the visit can be skipped, and so on.
The key for evaluating any IRT system is the extent to which the myriad of circumstances that can arise during a clinical trial are easily handled by a system that has already made such considerations a part of its default setup.
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