Role: Study Designer
Study Events are used to define the visits during which activities are collected, and can be leveraged for scheduling activities (i.e. schedule of assessments for Day 1, Day 2, Day 3, etc.) or for grouping/organizing activities which do not have scheduled time points (i.e. Adverse Events and Concomitant Medications).
Scheduled
Scheduled Study Events are used during the creation of activity plans (schedules of assessments) to indicate which day/visit a given activity is intended to be collected. This facilitates organizational structure during data collection and reporting of final deliverables. Typical scheduled study events include: Day -28 to -2, Day -1, Day 1, Day 2, Day 3, Day 4, etc.
Unscheduled
Unscheduled Study Events are used to capture ad-hoc activities during data collection. They may not be used for scheduling as part of activity plan creation but rather serve as containers for unplanned data collection. Most studies typically include only one unscheduled study event, titled ‘Unscheduled’.
Common
Common Study Events are similar to unscheduled study events in that they serve as containers for unplanned activities and cannot be used for scheduling as part of activity plan creation. However, only activities (‘forms’) which are also marked as common may be added to a common study event. This helps to enforce strict organization of important ad-hoc activities. Typical common study events include ‘AE/CM Details’ and ‘Protocol Deviations’.