Planning Study and Site Enrollment

You can project the enrollment expectations for studies and their study sites within the Maintain Study and Study Site Plans window. Each plan records a planned start date, planned enrollment target, and planned target date (date for achieving the enrollment target). You can modify plans until you finalize them by selecting the Baselined? field. To change a baselined study's plans you must supersede them with new plans. Furthermore, once enrollment for a study or study site has begun, you can no longer modify the planned start date in original or later plans.

For tracking actual study progress against the plan, use the study tracking reports. Specify the plan for the study from the Maintain Study and Study Site Plans window. From the Design menu, select Studies, then select Study and Site Plans. Select a study and modify the enterable fields as necessary. If you want to permanently record the plan for a study, select the Baselined? box.

The Study Plans window contains information about the Enrollment Plan for the study, including the Planned Start Date, Planned Target Date, and Planned Enrollment. Check that the Planned Target Date is greater than the Planned Start Date and that the Planned Enrollment is greater than zero.

Oracle Clinical calculates value of the Actual Enrollment field; you cannot manually update the field in this window. Oracle Clinical determines the actual enrollment based on the number of patients with a status of ENROLLED as calculated by the Patient Status Derivation Packaged Procedure. The system also maintains the Plan # field, incrementing it by one each time you create a new plan.

Oracle Clinical also maintains the Effective Date and Superseded Date. The current plan always has an Effective Date reflecting the time when the plan was created, and a Superseded Date of 15-AUG-3501. This date far in the future indicates that the plan has not been superseded, and is in fact the current plan. A plan with a Superseded Date of any other value was superseded at that time.