The Milestone tab allows the study team user to create and manage Milestones. There are five Milestone Types: Patient Status, Visit, Event, Study Status, and Additional Milestones. Additional about Milestones, Budgets and Financials, see Financial Management.
When adding milestones, all required fields are indicated by an asterisk and are defined below.
Note: If there is study calendar with a budget, create the initial Visit and Event milestones from the Manage Budget tab.
Milestone Section
Column Name
Description
Example
Patient Status
Patient Count
Specify the number of the patients that should be tracked. This column does not apply to the “Study Status” milestone type.
If a sponsor pays for every fifth patient screened, enter “5”. When every fifth patient on the study has the screen status added, a milestone will be achieved.
Patient Status
Specify the desired patient status that should be tracked.
N/A
Milestone Status
Specify the “Active” status when the milestone should be turned on or select “Inactive” if a Milestone no longer applies.
N/A
Visit
Calendar
Select the study calendar from which you want to derive the visit milestones.
N/A
Visit
Specify the visit name for the milestone
N/A
Milestone Rule
Select the logic that determines when the visit is considered complete
Options include:
“All events within the visit are marked as-“, “At least one event is marked as-“, and “On Scheduled Date”.
Event Status
Dependent on Milestone Rule field. This completes the logic selected in the previous field. This field is left blank if “On Scheduled Date” is selected in previous field.
Options include:
“Not Done“, “NotRequired“, “Done”, “To be rescheduled”, and “Suspended”.
Milestone Status
Specify the “Active” status when the milestone should be turned on or select “Inactive” if a Milestone no longer applies.
N/A
Event
Calendar
Select the study calendar from which you want to derive the event milestones.
N/A
Visit
Specify the visit name for the milestone.
N/A
Event
Specify the specific event associated with the calendar visit for this milestone.
N/A
Milestone Rule
Select the logic that determines when the event is considered complete.
Options include:
“All events within the visit are marked as-“, “At least one event is marked as-“, and “On Scheduled Date”.
Event Status
Dependent on Milestone Rule field. This completes the logic selected in the previous field. This field is left blank if “On Scheduled Date” is selected in previous field.
Options include:
“Not Done“, “NotRequired“, “Done”, “To be rescheduled”, and “Suspended”.
Milestone Status
Specify the “Active” status when the milestone should be turned on or select “Inactive” if a Milestone no longer applies.
N/A
Study Status
Study Status
Specify the study status that must be achieved for the milestone to be considered complete.
e.g. – “Active/Enrolling”, “IRB: Approved”, etc.
Milestone Status
Specify the “Active” status when the milestone should be turned on or select “Inactive” if a Milestone no longer applies.
N/A
Additional
Milestone Description
Enter a description of the milestone.
Any activity that needs to be invoices but the activity does not have a specific time point, e.g. – “Startup Fees” “Contract Renewal”, “Custom Recruitment/Retention Milestone”, etc.
Milestone Status
Specify the “Active” status when the milestone should be turned on or select “Inactive” if a Milestone no longer applies.
