How Optional Visits Interact with DCM Tracking

Making a visit optional, as in the case of the baseline 2 and early termination visits in the table below, tells the system to not report a problem if no DCMs are entered for the optional visit. However, if one or more DCMs is entered for an optional visit and other expected DCMs are not, the other DCMs become relevant and Oracle Clinical reports them as Missing.

Early termination visits are considered optional by default; normal termination visits are not optional and are handled as routine.

The following table is an example of a typical clinical study schedule that shows the planned receipt of expected (E) and optional (O) DCMs over eight visits.

Table 3-1 Clinical Study Schedule (Example)

-	Interval1---	---	Interval2---	---	---	---	---	---
Visit Numbers	1	2	3	4	5	6	7	8
Visit Names	Baseline 1	Baseline 2 (opt)	Visit 1	Visit 2	Visit 3	Normal Term	Early Term (opt)	Follow-up
DCM1	E(mpty)	E	E	O	E	E	E	E
DCM2	O(ptional)	E	E	E	E	E	E	E
TDCM	~	~	~	~	~	E	E	~

The table shows that the projected visit schedule includes:

• Two baseline visits, one of which is optional

• Three routine visits (Visits 1, 2, and 3)

• A normal termination visit

• An early termination visit, which is optional

• A follow-up visit

Also in the table above, three DCMs are in the study schedule:

• DCM1

• DCM2

• TDCM (Termination DCM)