The Study Schedule

Oracle Clinical forecasts expected data from the study schedule. The study schedule is created during the following activities:

• During study design, you establish the number of Clinical Planned Events (CPEs, usually patient visits), and the intervals between them. When you set up the CPE schedule, you enter offsets between visits or offsets from the beginning of an interval to indicate when visits should take place. (See Oracle Clinical Creating a Study for more information.)

• During study data definition, after you have created DCMs and DCM subsets, you define them as Expected or Optional against the CPEs in the DCM Schedule window. In other words, DCMs are created and then mapped to the visit schedule. (See Oracle Clinical Creating a Study for more information.)

Putting together the CPE schedule, DCMs and DCM subsets, DCM schedule, and the data that has actually been received, Oracle Clinical determines visit dates (actual or scheduled), projects expected DCMs, and identifies missing DCMs.

Oracle Clinical uses the date of the first received DCM as the actual visit date, and calculates the scheduled visit date from the following algorithm:

1. Oracle Clinical searches to find the earliest, non-null DCM date for scheduled DCMs received for the most recent planned visit with a visit number less than or equal to the missing DCM's expected visit number. If it finds such a non-null date, Oracle Clinical uses that date and visit number with the schedule of events to project the missing DCM's expected visit date.
2. If the first search fails, Oracle Clinical performs a broader search to find the earliest planned visit for which a scheduled or termination DCM with a non-null DCM date has been received. The date and visit number are used with the schedule of events to project back to the missing DCM's expected visit date.
3. If the first two searches fail, Oracle Clinical bases the schedule of events on the patient enrollment date, and projects forward the expected visit dates for missing DCMs.