Summary

This article covers how to define site milestones that will be tracked for each site.

Table of Contents

• Access Site Milestones Form
  • Milestone Column
• Add Standard Milestones
• Add Site Milestones
  • EDC Events
    • Offset in Days Field
  • Dependent on Other Milestones
    • Choose the Type of Dependency
    • Relate to Existing Milestones
    • Offset in Days Field
• Arranging Milestones
• Edit Milestone Dialog
• Confirm Delete Milestone Dialog

The Site Milestones form allows the ability to define milestones that will be tracked for each site. The Site Milestones defined at the Clinical Plans level will appear for each Site to collect the site specific dates. At the Clinical Plans level the site milestones are defined and ordered. At the site level the milestone projection, target and actual dates are defined for each site.

The Site Milestones established in Clinical Plans is viewable at each site. The same set of milestones are maintains across all sites to better enable reporting on site events. By keeping a consistent set of milestones we can compare the success and failing of sites to each other.

Access Site Milestones Form

The Sites Milestones form for existing studies can be accessed by clicking Site Milestones under the Clinical Plans sub-menu for the study.

The Site Milestones table is blank for a new study. Milestones need to be added to populate Site Milestones. The Site Milestones added at the Clinical Plans level will only list data in the Milestone column as data collection occurs only at the site level.

Milestone Column

Milestone columns for Site Milestones at the Clinical Plans level will include the name of the milestone and icons:

• Edit Icon – when selected the Edit Milestone dialog will appear.
• Delete Icon – when selected the Confirm Delete Milestone dialog will appear.

Add Standard Milestones

A Standard Milestone can be added to a study by clicking the “Add Standard Milestones” action found in the Actions Menu on the Study Milestones screen.

The Standard Milestone Dialog will appear with a table of all Standard Site Milestones defined in the CTMS Settings. Select the milestones desired to add to the site and click Save. This will import the Standard Milestones as they are configured in CTMS Settings. Any Standard Milestones of the type Targeted Date will be undefined by default. These require their Targeted Dates be configured for each site using the Edit Icon. Until these manually defined dates are specified, dependent milestones will have a warning icon indicating missing dependencies, though the system will attempt to calculate Projected and Targeted dates with what is provided.

Add Site Milestones

A Site Milestone can be added by clicking the “Add Milestone” action found in the Actions Menu on the Site Milestones screen.

The Add Milestone dialog will appear for a site level milestone to be added. The Add Milestone dialog for sites does not collect a Targeted Date, so the associated fields will be locked.

The Add Milestone dialog allows user the ability to define the site 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.
  • 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.

EDC Events

When EDC Events are selected from the data relates dropdown the Offset in Days field and a new dropdown appears with options. The EDC Events at the site level will populate the date for the linked site.

• 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 Site Enrollment form.
• 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 Site Enrollment form.
• Database Lock – will derive its Actual Date from the date that all patients at the EDC site 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.

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 EDC Event.

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 site 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.

Arranging Milestones

Once multiple Milestones have been added to the table, they can be rearranged by left-clicking and dragging the Milestone up or down in the table.

Edit Milestone Dialog

The Edit Milestone dialog displays the data added through the Add Milestone Dialog to be updated. The Edit Milestone Dialog allows the ability to update the Milestone Name and the Milestone Type and settings for the milestone.

Confirm Delete Milestone Dialog

The Confirm Delete Milestone dialog displays a confirmation to confirm the removal of the site milestone. Selecting Delete will remove the milestone from all sites.

Need more help?

Please visit the Fountayn Contact Information page.