Summary

This article provides an overview of the randomization system.

Table of Contents

• Definitions
  • Activation and Randomization
  • Product Labels
  • Drug Types
  • Treatment Types
  • Email Trigger Events
  • File Output Settings
    • Excel File Settings
    • CSV File Settings
  • Import File Requirements
    • Supported formats
    • Sample Files With Headers
    • Sample Files Without Headers

Design | System

Fountayn’s Randomization & Trial Supply Management system 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.

Instructions on how to operate the system are located in the Navigation bar on the left. Each section contains steps that need to be completed for all environments (design, test, approve, production, training site) in which the system will be used. The basic roles for using the system are the Coordinator and Investigator roles. Additional roles can be configured by the Trial Designer.

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.

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, 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.

Email Trigger Events

• Randomization
• Emergency Unblinding
• Shipment Cancellation
• Shipment Confirmation
• Shipment Request
• Inventory Empty
• Inventory Transfer
• Inventory Threshold Reached

File Output Settings

Excel File Settings

• Max Column Width – always leave this setting with the default value
• Print as Landscape – sets the excel spreadsheet to print as landscape
• Use Adaptive Cell Width – resizes the width of the cells to fit the length of the column names
• Wrap Cell Text if Necessary – resizes the height of the cells to fit the length of the column names

CSV File Settings

• Column Delimiter – the character that separates each column name and value
• Column Qualifier – the character that surrounds a column name or value
• Line Separator – designates how line breaks are coded in the file

Import File Requirements

In order to import a Strata or Inventory file, the file must be one of the supported formats. Block IDs should be unique per block. That is, they should not be reused across multiple blocks. Also be sure that there are no blank rows or extra information as this can cause errors.

Supported formats

• .xls
• .csv

Sample Files With Headers

Sample Files Without Headers

Note: Fountayn does not recommend loading files without headers. Doing so can lead to fields being improperly imported.

Need more help?

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