Summary

This article covers the app properties associated with Randomization.


Table of Contents

Specify Randomization Version

The correct version must be specified in order for Randomization to work.

  1. Name: Enter ‘randomizationVersion’
  2. Value: Enter ‘3.0’


Set activationMethod Text

While the terms, Activation and Randomization, are used interchangeably throughout this manual, you can choose which term is displayed within the system. If the activationMethod property is not defined in the App Properties worksheet, the term, Activation, is used by default.

  1. Name: Enter ‘activationMethod’
  2. Value:
    • Enter ‘randomization’ to use the term, randomize, throughout the study
    • Enter ‘activation’ to use the term, activate, throughout the study

Enable Visit-Specific Drug Assignments

If a drug is to be dispensed at several time points throughout the study, the following property can be defined to assign a drug based on the visit number. Without the following property, the option of designating drug assignments for a specific visit or time point will not be possible.

  1. Name: Enter ‘drugAssignmentVisit[number]’ followed by a sequence number. The Number must start with 0 or 1 and go in sequence order.
  2. Value: Enter the name of the visit.
    • Example: ‘Visit 1’ or ‘Day 3’
  3. Name: Enter ‘drugAssignmentVisit[number]Question’ where the number corresponds to the previously used sequence number.
  4. Value: Enter the question path that corresponds to the visit question that should be auto-populated with the assigned drug’s container ID.
  5. Repeat the steps for each visit-specific drug assignment.
    • The following example defines a visit-specific drug assignment for the first and fifth visits.


Drug Assignments with an Expression

Expressions can be used in conjunction with properties outlined in the Drug Assignments without an Expression section. When these expressions evaluate to true, the visit will show within the ‘Visit:’ drop down within the ‘Drug Assignment’ screen.

  1. Repeat steps 1 – 4 in the Drug Assignments without an Expression section.
  2. Name: Enter ‘drugAssignmentVisit[number]Expression’ where number is the sequence number used in the previous step.
  3. Value: Enter the expression that will make the visit show in the drop down. The expressions use the eClinical expression language within our system.
  4. Repeat steps 1 – 3 for each visit.



Removing Visits with Assigned Study Product

Visits can be removed from the ‘Visit:’ drop-down within the ‘Drug Assignment’ screen by using the ‘removeAssignedVisit’ property. When the property is set to ‘true’ visits will be removed from the drop down when study product has been assigned to the question specified in the ‘drugAssignmentVisit[number]Question’ property. By default the property is set to ‘false’ if not configured.


Defining the Amount of Study Production to be Assigned

The amount of study product can be set for each Visit-Specific assignment in the configuration. This is accomplished by using the ‘drugAssignmentVisit[number]Amount’ property. The value that is specified could a static value or a drop-down of values that can be selected. This change would be applied to the ‘Amount:’ field within the ‘Drug Assignment’ screen.

  1. Repeat steps 1 – 4 for either the Drug Assignments without an Expression or Drug Assignments with an Expression section. All depends on the configuration the study utilizes.
  2. Name: Enter ‘drugAssignmentVisit[number]Amount’ where number is the sequence number used in the previous step.
  3. Value: Enter ‘drugType[number]:[amount]’ where number is the ‘Drug Type ID’ on the ‘Inventory’ tab of the dA and amount is the amount/quantity of study product that should be statically set.
    • If there are multiple study products or multiple static amounts for a study product, the following format shall be used:
  4. Value:‘drugType[number]:[amount]||drugType[number]:[amount]’
    • Repeat steps 1-3 for each visit.


 

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