Summary

This article provides an overview of the activation process.

Table of Contents

Refer to the list of deprecated features for information on the properties no longer used in the latest versions of the Randomization & Trial Supply Management solution.

Set the Activation ID and Failed Activation Message

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Assignment Type: Enter the Assignment Type for activation.
  3. Customized Footer Text for Failed Activation Attempts: Enter “Your subject failed to be randomized” or some other brief message that will be displayed when the activation attempt fails.
  4. Initial Activation ID: If the Assignment Type is ‘sequential’ or ‘sequential_site,’ enter a number to be the initial activation ID. Otherwise, leave this cell blank. If blank, the default initial value of ‘R0001′ will be used.
Note: The Initial Activation ID can be no longer than 90 characters.
If the Activation ID is numeric the value for the initial ID needs to be set to a value that will not increase in scale. For example:
  • If > 10 patients expected, the Initial Activation ID should be no less than 10.
  • If > 100 patients expected, the Initial Activation ID should be no less than 100.
  • If > 1000 patients expected, the Initial Activation ID should be no less than 1000.
  • If > 10000 patients expected, the Initial Activation ID should be no less than 10000.


Note: If you randomize patients and then delete those patients without derandomizing them, the ID will reset which may cause duplicates in the schedule. This case will not normally happen in a production environment but may appear in testing/design environments.


Set the Activation Criteria

When activating a subject, the activation criteria will be used to assure they are ready for activation. The alert text will be shown for each criteria that fails when the patient fails the activation check when you click the ‘Check Activation Status’ link or attempt to Activate/Randomize a patient within the Randomization System.

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Criteria: Using the eClinical expression language, enter the logic expression that will be used to enforce the data requirement.
  3. Alert Text: Enter a brief message that will be displayed when the criterion is not met.
  4. Repeat the process for each activation criterion.


Set the Criteria Confirmation Questions (Deprecated Feature)

You can leave this section blank in the DA. However, be sure to not remove the property headings as this will cause errors when compiling the DA. Refer to the list of deprecated features for information on the properties no longer used in the latest versions of the Randomization & Trial Supply Management solution.

Set the Activation Confirmation Questions

After completing a successful subject activation, the system will display an Activation Confirmation Message. This message will contain the information provided by you in this section.

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Activation Confirmation Question: Enter a label for each data value that you wish to have included in the Activation Confirmation message.
  3. Value: Enter the data value that will be displayed in association with each Activation Confirmation Question.
    • This value can be an absolute path to a field/data value within the clinical application such as, ‘#sc.subjid’ or it can be a Randomization Manager variable.
  4. Override Question: Deprecated Feature, leave blank.
  5. Override Value: Deprecated Feature, leave blank.


Set the Blinded Field properties

If you complete this section, the system will check the Roles and Permissions defined for the study to see which roles have permission to view blinded information. If you don’t want Blinded Fields, skip this section. Note that if you have blinded fields, they should be defined in this section as well as the Activation Confirmation Question section. Entering them in the Activation Confirmation section adds them to the receipt and the Blinded Field section controls the visibility based on the blinding permission.

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Blinded Field: Enter the Randomization Manager variables that should be blinded.
  3. Repeat these steps for each blinded field.

Randomization related assignments allow randomization related data to be placed into the Subject’s Casebook.

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. Assignment Question: Enter the absolute path for the clinical application question or data field.
  3. Value: Enter the Randomization Manager variables from the list you created in the Activation Confirmation Question section.


Set the Time and Date Formats

  1. Configuration ID: Enter the number that corresponds to the Configuration ID in the Configuration worksheet that you want to use.
  2. dateTimeFormat: Enter the format that you want to use for the activation date and time.
  3. dateFormat: Enter the format that you want to use when you reference the ACTIVATION_date variable.
  4. timeFormat: Enter the format for the ACTIVATION_time variable.
  5. locale: Enter the study-specific location used to determine the display language.
    • This is a two-letter language code. The three supported locales are ‘ja’ for Japanese, ‘zh’ for Chinese and ‘en’ for English.
  6. timeZone: Enter the study-specific timezone used to determine the date and time of randomization.
Note:  If no timezone is indicated, the system will use the timezone of the user who performed the randomization action.



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