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RTSM Epic 8 PCO MCC-488376 HDF 2019.1.2: Hide Dosing Factors from Blinded…
RTSM Epic 8 PCO
MCC-488376 HDF 2019.1.2: Hide Dosing Factors from Blinded Users
Roles
Roles that can edit study design they can check/uncheck this checkbox.
Live studies with shared factors and where "Hide Randomization Factors from blinded users" checkbox is checked.
Rake task will be run for these studies after deployment which will set ""Hide Dosing Factors From Blinded Users" checkbox to "True"
Audits
Audit is captured while checking and unchecking the checkbox.
Types of studies
ELD or Simulate Live study
"Hide Dosing Factors From Blinded Users" checkbox should be Real Only.
Treatment Period
For Live study "Hide Dosing Factors From Blinded Users" checkbox should be Read Only.
"Hide Dosing Factors From Blinded Users" checkbox should be displayed on Master Design Page.
Cohorts
When one of the cohort goes Open-enrolling , "Hide Dosing Factors From Blinded Users" checkbox should be Read Only.
"Hide Dosing Factors From Blinded Users" checkbox should be displayed on Master Design Page.
"Treatment Design" Page
"Hide Dosing Factors From Blinded Users" checkbox added
When user unchecks this checkbox user sees modal saying"Confirm Dosing Factor Visibility Change"
'Changing this option may potentially reveal blinded information. Are you sure you want to continue?'
For Existing studies this checkbox will be set to "False" i.e. unchecked by default.
Configuration Report will have details for dosing factors
Subject Page
Dosing Factor levels table will be hidden from blinded users if "Hide Dosing Factors From Blinded Users" is checked
Dosing Factor levels table will be visible from blinded users if "Hide Dosing Factors From Blinded Users" is not checked
When Subject is Unblinded, on Unblinded data modal Dosing factor levels details should be displayed.
When study has "Trial Continuity" on , then for non Synchronized subjects, on "Subject Synchronization Summary" Dosign factor levels should be hidden or Visible depending on checking or unchecking of this checkbox
Subject Reports
Subject Treatment Report
Dosign factor levels (Parameter Group) should be hidden or Visible to blinded users depending on checking or unchecking of this checkbox.
Subject Distribution Report
No Impact
Subject List Report
Dosign factor levels should be hidden or Visible to blinded users depending on checking or unchecking of this checkbox.
Unblinded users should be able to see dosing factor
import
User should be able to import studies successfully , setting for "Hide Dosing Factors From Blinded Users" should be imported as is.
Cross Browse Testing
Chrome50/OSX 10.11
FF51/OSX 10.11
Safari10/OSX 10.11
IE11/Win8.1
Edge/Win10