Summary
This article covers creating standard milestones in the navigation menu of the CTMS settings.
Table of Contents
Standard Milestones allows users to define default milestones that can be added to Study Milestones and Site Milestone under Clinical Plans for each study. Standard Milestones can be created from the Standard Milestones Screen found in the navigation menu of CTMS Settings. By prototyping the most common milestones in CTMS Settings, they can then be easily pulled into new studies without replication.
This does not restrict users from creating milestones that are particular to individual or groups of studies or sites. However, by creating a listing of Standard Milestones that are common to most studies or sites, we can then utilize these to generate average performance metrics in the Milestone Summary Report.
Default Standard Study Milestones
Four Standard Milestones appear in CTMS Settings by default: Clinical Study Report, Tables Figures and Listings, First Regulatory Submission and Kick-off Meeting. These can be edited as needed.
Add Standard Milestones
Navigate to the Standard Milestone page for either Study Milestones or Site Milestones.
Access the “Add Standard Milestone” action found in the Actions Menu at the top right of the screen
Add Milestone Dialog
The Add Milestone dialog allows user the ability to define the standard milestone.
- Milestone Name – the Milestone Name is the name of the milestone and will be the label of the milestone in the study, reports and mangers.
- Milestone Type – Select how the milestone date relates with other events:
- Specified Date – the projected date will be specified and is not dependent on other milestones.
- EDC Event – the actual date will be populated based on activities in EDC and First/Last Patient dates.
- Dependent on other Milestones – the projected date will be dependent on another milestone.
The following table explains how the selection for the milestone date relates to the milestone table.
| Milestone Type | Targeted Date | Projected Date | Actual Date |
|---|---|---|---|
| Specified Date | Manually documented. | Manually documented. Uses Targeted Date until Projected Date is provided. | Manually documented. |
| EDC Event | Manually documented. | Manually documented. Uses Targeted Date until Projected Date is provided. | Auto-populated by actions in EDC for linked studies managed in EDC. |
| Dependent on other Milestones | Calculates based on dependent milestones Target Date. | Calculates based on dependent milestones Actual date if provided, if not documented yet Projected Date is used in projection. | Manually documented. |
EDC Events (studies linked to Fountayn EDC only)
When EDC Events are selected from the data relates dropdown the Offset in Days field and a new dropdown appears with options:
- First Patient First Visit – will derive its Actual Date from the earliest date of completion for the First Visit based on the study’s Visit Schedule.
- Last Patient First Visit – will derive its Actual Date from the latest date of completion for the First Visit based on the study’s Visit Schedule and estimated enrollment numbers defined on the Project Plan for Study Milestones and Site Enrollment for Site Milestones.
- First Patient Last Visit – will derive its Actual Date from the earliest date of completion for the Last Visit based on the study’s Visit Schedule.
- Last Patient Last Visit – will derive its Actual Date from the latest date of completion for the Last Visit based on the study’s Visit Schedule and estimated enrollment numbers defined on the Project Plan for Study Milestones and Site Enrollment for Site Milestones.
- Database Lock – will derive its Actual Date from the date that all patients at EDC sites are Locked. The date will be removed if any are subsequently unlocked, or if additional unlocked patients are created.
Note: When mentioning the date of visits in the Visit Schedule is the Data Type must be a date and a Patient Status label must be defined. The First one is the First Date listed in the order of the Visit Schedule. The Last one is the last Date listed in the Visit Schedule.
Dependent on Other Milestones
When Dependent on Other Milestones is selected from the data relates dropdown the Milestones have been Reached field, Dependent Milestone field and Offset in Days field will appear:
Choose the Type of Dependency
The Choose the Type of Dependency dropdown contains options to define how the milestone will calculate when more than one milestone is selected as a dependent:
- After ALL of these Milestones have been reached – when selected the projection will look at all milestones selected as dependent milestone that have to be completed before projecting the date.
- After the FIRST of these Milestones has been reached – when selected the projection will look at the earliest milestone completed when projecting the date.
Relate to Existing Milestones
The Relate to Existing Milestones field contains a multi dropdown select that contains all created milestones. All milestones selected here will have their Projected or Actual dates assessed when calculating a Projected Date for the dependent milestone.
Offset in Days Field
Offset in Days field is an integer field used to collect the number of days the targeted and projected date shall calculate in addition to the dependent milestone date.
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