Summary

This article provides an overview of randomization 3.0 in trial design.

Table of Contents

Design | System

Fountayn’s Randomization & Trial Supply Management product is a management tool that allows for the randomization of subjects and the maintenance of drug inventory. With this tool you can randomly assign drugs to subjects, keep track of inventory, and export and review tabular summaries of randomization-related data. If configured, the tool also supports emergency unblinding of the subjects.

This manual is written to support Randomization 3.0. Fields that are deprecated are marked and can be skipped.

Trial Design

Before the Randomization system can be used, the Data Architect file must be configured. The Data Architect contains worksheets with information related to your study. Instructions regarding the worksheets required for Randomization and the properties that must be filled out on each worksheet can be accessed through the Navigation menu on the left.

Definitions

Refer to this section when you are unsure about a specific term or system variable.

Activation and Randomization

The terms, Activation and Randomization, are used interchangeably throughout this manual. Both refer to the process of assigning a subject to a randomly generated assignment schedule that may or may not be known by the subject, site and sponsor.

Algorithms

Three algorithms are available for selection when configuring randomization.

  • Stratification – Generates a randomization schedule made up of stratified blocks.
  • Institutional Balancing – Works like Stratification but minimizes treatment imbalance within each site based on the Institutional Balancing Threshold.
  • Minimization – Minimizes treatment imbalance based on the calculated imbalance score and minimization probability. This algorithm reflects certain elements of the implementation of Minimization as published in the the 1975 paper, “Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial” by Stuart J Pocock and Richard Simon.

Randomization Manager Variables

  • ACTIVATION_activationId – Randomization ID
  • ACTIVATION_date – Date of Randomization
  • ACTIVATION_drugLabel – Drug container ID
  • ACTIVATION_drugTypeName – Drug Name
  • ACTIVATION_fullName – User who performed randomization
  • ACTIVATION_time – Time of randomization
  • ACTIVATION_treatmentTypeName – Treatment type assigned
  • ACTIVATION_dateTime – Date and Time of randomization

Product Labels

The Randomization and Trial Management Managers’ actions and screens shall display product labels based on Trial Manager Product Type indication on the Set-up Page. This setting in Trial Manager can be updated by the roles Configurator, Clinical Project Manager, CTA, FTYN Debug, Project Manager, Teamwork Configurator, and Trial Designer.

Drug Types

Drug Types represent the different compounds used to conduct the study. Studies with one drug type will likely have multiple treatment types associated with the drug type.

Treatment Types

Treatment Types represent the various dose levels of each compound. Studies with multiple drug types may have only one treatment type associated with each drug type.

Server Types

  • general – functions on all servers
  • Local – functions within a local development environment
  • Staging – functions on the design, test and approve servers
  • Production – functions on all production servers

Assignment Types

  • sequential – assign the randomization ID sequentially by trial. You define the initial activation ID
  • sequential_site – assign the randomization ID sequentially by site. You define the initial activation ID
  • drugLabel – assign the randomization ID to match the bottle/kit number assigned to the subject upon successful randomization
  • slotID – assign the randomization ID based on the imported schedule
  • custom – assign the randomization ID based on custom programmed assignments

Email Trigger Events

The following email triggers can be used to notify recipients of different events. They use configurable VM files as email templates. If no customized VM files are associated with the study, the default system templates are used.

  • activated – triggers email each time a subject is activated
  • drugAssignment – triggers email when a drug is assigned to a subject
  • unblinded – triggers email when subject is unblinded
  • shipmentConfirm – triggers email when a shipment is confirmed
  • cancelShipment – triggers email when a shipment is canceled
  • shipmentRequest – triggers email when a shipment request is made
  • shipmentRestore – triggers email when a shipment has been restored after deletion
  • inventoryThreshold – triggers email when the inventory reaches its threshold
  • inventoryEmpty – triggers email when the inventory is empty
  • inventoryTransfer – triggers email when a manual inventory transfer occurs



Note: A shipmentRequest email is triggered by the automated threshold based drug supply and by the initiateShipment action from the action menu.


Creating a shipment by individually selecting containers from within Drug Container Manager based on the createShipment permission does not trigger a shipmentRequest email.

Contact Information For Email Triggers

Context Keys are used to customize email templates. Usually Context Keys need to be defined on the Email Triggers worksheet. However, several Context Keys related to site contact information no longer need to be defined on the worksheet. Instead, they must be defined on the Site form within the Trial Manager.

The following is a list of fields from the Site Form that are used on email templates:

  • Site Name
  • Street Address Line 1
  • Street Address Line 2
  • Suite/Office/Floor
  • City
  • State/Province
  • Postal Code
  • Country
  • Phone Number
  • Fax Number

The following is a list of the Data Architect Context Keys that were replaced by the fields on the Site form.  These keys can be used for customized email templates.

  • addressLine1
  • addressLine2
  • addressLine3
  • addressLine4
  • addressLine5
  • attn
  • phoneNumber
  • surname
  • emailAddress

For additional information regarding email templates, see the manual on customizing email templates.

Deprecated Features

The following is a list of properties that are not used in Randomization & Trial Supply Management product versions 3.0.0 or higher. These property headings should still be included in the worksheet but their values can be left blank.

Activation Worksheet

  • Criteria Confirmation Question
  • Override Question
  • Override Value

Inventory Worksheet

  • Save Assigned Drug Kit Number
  • Assignment Question Type
  • Use Alternative Treatment
  • Use Sub-container

Bridges Worksheet

  • This worksheet is no longer used for Randomization

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