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CTMS Std Milestones Last Subject Last Visit Notes

Overview

CTMS Std Milestones are a fixed set of milestone dates created for Sites, Countries and Studies.  They are supported by a series of scripts that update the milestone dates with "First" and "Last" dates from the lower levels.   For example: When a Site is set to "Open" by entering the Site Open Date, the Roll-up will check to see if it is the first Site in a Country or Study to be Opened, and then update the First Site Open at County and Study levels.

For a further overview of Std Milestones see Standard Milestones in online help. 

Technical Notes:

  1. The Std Milestone Dates will Roll-up by default in real-time with each screen refresh.
  2. The Study "Milestone - Roll-ups Enabled" Attribute setting is ONLY required to set the Roll up to work on a Batch basis, rather than Real-time. Note: For RMI Studies the Rollup batch is required.
  3. To Edit the Milestone Planned Dates, you need to set the Role Property COUNTRY_MILESTONES_PLANNED_EDIT = true per user Role, to authorize that Role to update the Planned Date fields.

Example Std Milestone View in CTMS

Note: The Expected dates are only editable at Site Level as standardmilestones.sitelevel.expected.rollup.enabled is set to "true"allowing the Dates to Rollup to Country and Study.  See the Rollup of the Site Open Dates.

Site Level

Country Level

Study Level

 

Overview of Std Milestone Actual Date Rollup

 

Derivation Rules for Std Milestone Actual Dates

Note: Sites with Status=Not Selected, and Subjects with Status="Screen Failed" are excluded from the rules below.

 

1     First Site Open

  • First Site Open Date sets the Site level and auto Rolls up to  Country and Study

 

2     First Subject Screened and First Subject Enrolled Dates  (Screened and Enrolled dates are separate but use the same rules)

  • First Subject Screen/Enrolled Date sets the Site level date and then auto Rolls up to Country and Study

 

3     Last Site Open

  1. Site Level  (Not applicable to Site level)

  2. Country Level
    • All Sites in Country have Site Open Date + Site Recruitment Closed set at Country Planning Level

  3. Study Level
    • All Sites in Study have Site Open Date + Site Recruitment Closed set at Study Level

 

4     Last Subject Screened and Last Subject Enrolled Dates  
Screened and Enrolled dates are separate but use the same rules so are documented together below

  1. Site Level
    •      Subject Screen Date/Enrolled Date + Subject Enrollment Closed checkbox checked in Site view
  2. Country Level
    • All Subjects in Country have Screen Date/Enrolled Date + Subject Enrollment Closed checkbox checked in Country Planning
  3. Study Level
    • All Subjects in Study have Screen Date/Enrolled Date + Subject Enrollment Closed checkbox checked in Study view

Note: Study>Subject Enrollment and Country>Subject Enrollment Closed checkboxes propagate and override the Countries and Sites below.

 

5     Last Subject Last Visit (LSLV)

  1. Site Level
    • Subject Visit of type = End of Study is completed with Completed Date  PLUS     
      (See End Of Study section below for derivation) 
    • Subject Recruitment Closed checkbox checked in Site view 
      (If checkbox is set in parent Study/Country. it is already set by default and not changeable)
  2. Country Level
    • All Subjects in Country have Subject Visit of type = End of Study completed with Completed Date PLUS
    • Subject Enrollment Closed checkbox checked in Country Planning view 
      (If checkbox is set in parent Study, it is already set by default and not changeable)
  3. Study Level
    1. All Subjects in Study have Subject Visit of type = End of Study completed with Completed Date PLUS
    2. Subject Enrollment Closed checkbox checked in Study view 

 

Configuration of End Of Study (EOS) Visit type 

The End Of Study Visit used in the Last Subject Last visit milestones above must be set with Type = "End Of Study".  The EOS type is set in the subjectActivityCategory dropdown.  The EOS visit type is set either via template configuration, or manual edit of each EOS subject visit.  See detailed explanation below.

 

  1. Pre-configure the EOS visit type in Activity templates 
    The preferred method to manage the EOS visit required LSLV Std Milestone, is to define the visit type as "End Of Study" in the Subject Activity Definitions view.
    1. Goto Activity Templates>Base Templates>Subject Activity Names
    2. Select type = Visit
    3. Select the intended Study
    4. Search for the Activity Name required for editing.  (Make sure its the same reference as the one used in the visit)
    5. Set the Category dropdown option to "End Of Study" (This dropdown is exposed as "Visit Type"  in the Subject Visit view) 

    6. Setting the visit name definition to "End Of Study" will impact all subject visit templates globally in CTMS
    7. That is: All subsequent visits generated with that name definition, will reflect the EOS type.

  2. Update EOS type in generated Subject Visits
    If many of the required EOS visits are already generated, the following process shows how to update the generated visits:
    1. Edit the Activity Name Definition as described in step (a) above
    2. Goto Activity Templates>Study Assigned Templates>Subject Type Templates and click on the [Tools To Adjust Generated Activities]
    3. Select the intended Study and select the [Other Fields] option
    4. Check the Category  Checkbox  (Shown as "Type" in Visit view)
    5. Check the Include all Records marked as Complete Checkbox
      (To update Completed visits as well, if required)
    6. Then click [Refresh Other Fields]  
      See screenshot below:
    7. The tool will run and respond with the number of records updated.
    8. This will update the visit type of all existing generated visits to the Category selected in the Activity Name Definition

  3. Individual Subject Visit update
    If for some reason the EOS visit required for the LSLV Std Milestone is not the visit configured as EOS, it is possible to manually set the visit type in the Subject Visit view.  To do this you need to update each Subject Visit intended as a EOS visit, using the Visit Type dropdown.


  4. Managing EOS Visits in RMI Created Templates
    RMI integrated Studies will automatically create and manage the study assigned subject visit template, but does not recognize or manage EOS visits in CTMS.  It is therefore required that the EOS visit is manually configured in the RMI template after creation by the IMportRaveVisitCRFTemplates integration.  
    1. Follow the steps described in (a) above to set the Activity Name Definition for EOS
    2. Follow the steps described in (b) above to update all generated visits
    3. Follow the steps described in (c) above to manually edit individual Subject Visits, if not using the preconfigured visit.

 

For more information on Std Milestone Dates see About Standard Milestones in CTMS in online help.

 

Std Milestone Configuration and dependency Checklist

This is a useful checklist to verify and understand all the underlying settings.


1   Std Milestone Templates
  (Study specific)

Assign STD MS Templates to Study

 

2   Back Office Property (Global)

standardmilestones.sitelevel.expected.rollup.enabled  true = Site Expected Date Readonly,  false = editable.

This property defines the system's ability to auto-rollup site and subject EXPECTED standard milestones from the Site level to Country and Study level.

 

3   Study Attributes (Study specific)

Milestone>Milestone Tracking at Site Level for Actuals  Y/N
If this attribute is turned ON, it will allow manual entry and import of actual milestone dates at site level.
By default this attribute is turned OFF to allow Actual dates to auto-populate at Site Level and Rollup.

Milestone: Rollups Enabled Y/N
Set to Y to automate the rollup of data via batch job. Tisd also makes the Expected Date Read-Only at Country and Study Levels 

4   Role Properties (Role Specific)

Required for each Role to edit Planned Dates
COUNTRY_MILESTONES_PLANNED_EDIT
SITE_MILESTONES_PLANNED_EDIT
STUDY_MILESTONES_PLANNED_EDIT 

5   Site to Country to Study Rollup Dependencies
      
The Country uses the Site Address to determine the country which connects the Site Rollup to the Study

       Make sure: 
       -    Each Site has a valid Site Address set as a Subject Location
       -    There is a matching Country Added

6   Real-Time Milestone Triggers

The following triggers work in real-time so will ensure that the dates Rollup to the next level when data changes and the view is refreshed.

Actual Milestone Country Rollup
Actual Milestone Study Rollup
Expected Milestone Country Rollup
Expected Milestone Study Rollup
Milestone Site Rollup
Milestone Study Country Rollup
Milestone Study Rollup
Milestone Subject Rollup
Milestone Subject Visit Rollup 

7   Configuration options for Std Milestones

 

Troubleshooting Standard Milestones


1   Milestone Date Roll-up fails for a Site

Std Milestone Templates must be assigned to the Study

  • Check via Templates > Standard Milestone Template Copy

The milestone Date roll-up uses the Site Address to determine the country.

  • Check the following Site Address criteria:
  1. Site Address exists
  2. Subject Location check-box is checked
  3. Primary Check-box is checked

 

2   Unable to edit the Milestone Planned Dates
Each user Role is assigned permission to edit the Planned Dates.
Try selecting another Role, if that does work note the settings below.
The edit permissions are set per Role using the following Role Properties:

  • STUDY_MILESTONES_PLANNED_EDIT
  • COUNTRY_MILESTONES_PLANNED_EDIT
  • SITE_MILESTONES_PLANNED_EDIT

 

3   Site Actual Milestone Dates show as editable and not Rolling up from Site Dates
CTMS provides an option to manually set these dates via an import, or manual entry.
This feature is controlled by the following Study Attribute:
    Milestone>Milestone Tracking at Site Level for Actuals
If this attribute is set to "Y", it will make the Actuals fields editable for manual entry and allow manual import of actual milestone dates.
This attribute must be turned off (Set to "N") to enable Actual dates to be auto-populated at Site Level and Roll-up to Country and Study.

 

4   Milestone Dates do not roll-up in Real Time
CTMS provides an option to roll-up dates from Site through Country to Study on a batch basis.
This feature is controlled by the following Study Attribute:
    Milestone: Rollups Enabled Y/N
When Rollups enabled is set to "Y", it will only Roll up when running the batch Job manually or via Hourly/Daily quartz Job runner.  For Real Time updates set the property to "N"

The roll-up batch job = MileStone Rollup Batch which can be run manually from Super Admin>Work Flow>Job Runner.

 

5   How to set the Site Expected Dates to roll-up to Country and Study
CTMS provides an option to roll-up the Expected Dates from Site level
This feature is controlled by the following Backoffice property:
    standardmilestones.sitelevel.expected.rollup.enabled
To activate Expected Date roll-up for Country and Study levels, set to "true"
To make Country and Study levels independently editable, set to "false"

 

6   Milestone Roll-ups not working in a new Study
CTMS Standard Milestones use Study, Country and Site templates to manage the Milestone Dates.
If the roll-up is failing for a particular Study, then check that the attribute Milestone: Rollups Enabled =Y.

Its also possible the Std Milestone Templates are not yet assigned to the Study.
To assign: Study, Country and Site templates to a Study, see the following knowledge articles:

  1. Setting and Modifying Standard Study-level Milestone Dates in CTMS
  2. Setting and Modifying Standard Country-level Milestone Dates in CTMS
  3. Setting and Modifying Standard Site-level Milestones in CTMS 

 

7   Editing the Expected Date renders the following error:

 

Check to see if the STD Milestone Templates are assigned to the Study.

Goto Templates>Std Milestone Templates Copy and select intended Study

        -   If CTMS no Templates to copy, than they are already assigned
        -   if the system shows check boxes, then check these to assign the missing templates to Study

 

If you need further assistance please contact Medidata Helpdesk support or your Project Manager.

 

 

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