Summary

This article covers how to define the milestones for the specific study on the study milestones form.

Table of Contents

• Access Study Milestones Form
  • Add Standard Milestones
  • Add Study Milestones
• Study Milestone Table
  • Milestone Column
  • Targeted Date
  • Projected Date
  • Actual Date
  • Comment
  • Arranging Milestones

Study Milestones form allows the ability to define the milestones for the specific study. The milestones defined at the Study Milestone level is for the overall studies. Milestones that are site specific should be documented in the Site Milestone screen.

Access Study Milestones Form

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

The Study Milestones table is blank for a new study. Either Standard Milestones or Study specific milestones can be added.

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 Milestones defined in the CTMS Settings. Select the milestones desired to add to the study and select 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 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 Study Milestones

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

The Add Study Milestone will appear for a study level milestone to be added. The Add Study Milestone will contain a field to define the Target Baseline for the study milestone when Specified Date and EDC Event is selected.

Study Milestone Table

Once Standard or Study Milestones are added to a study the Study Milestones table displays a row for each added milestones.

The Milestone table includes the following columns:

Milestone Column

Milestone columns will include the name of the milestone and icons:

• Edit Icon – when selected the Edit Study Milestone dialog will appear.
• Delete Icon – when selected the Confirm Delete Milestone dialog will appear.
• Audit Icon – when selected the audit table for the milestone will appear.

Targeted Date

The Target Date is the baseline date for the milestone. The Targeted Date is manually defined for Specified Date and EDC Events on the Add Milestone screen. The Target date for Dependent Milestones calculates it’s Targeted Date based on its dependency relationship.

Projected Date

The Projected Date will add the offset days defined for the milestones. When a user hovers their mouse over the projected date a pop-up will appear and show the settings for the calculation, including any offset days.

The Projected Date can be updated by selecting the Update Icon beside the Projected Date. The Change Projected Date screen will appear to provide the updated projected date.

Actual Date

The Actual Date will provide the date the milestone was achieved. For EDC Event milestones the Actual Date is auto-populated based on the data in the EDC. For Specified and Dependent Date the actual date must be provided through the Update Icon in the Actual Date column. The Milestone is Complete screen will appear to provide the actual date.

Comment

The Comment column displays comments made by users with editing access to milestones. The comments can be viewed by all users with access to this screen. Clicking the Comment column Update icon allows users with editing access to document/edit a comment. Comment activity can be located on the Milestone Audit Trail as well as in the Question Audit Manager. Comments can be viewed on the Study Milestone Metrics Report.

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.

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