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Randomization item

Design considerations for Randomization item

Design consideration

Description

Item

Randomization.

Purpose in the InForm application

Holds a sequence and drug kit number generated by InForm randomization processing.

Required form?

No. The special randomization item can appear on any form.

Default version generated?

No.

Required items?

  • Item—Randomization.
  • Item type—Text. The field appears in the InForm application in the format sequence / drug_kit_number.
  • Special Fields property—Randomization field (Randomization).

Other requirements

  • An item with the Special Fields custom property value of Randomization field (Randomization) can occur only once in a study.
  • The following configuration is required on the computer hosting the InForm study:
    • Define a randomization sequence for each different list of drug kits used in the study and install it in the study database using the MedML Installer tool.
    • Configure the randomization data source manager.
    • Configure the format of each randomization sequence.
    • Set up a randomization source database.
    • Create an ODBC connection for the randomization source database.

      For more information, see the InForm documentation (Study and Reporting Setup Guide).

  • In the Central Designer application, a randomization rule is required to generate the sequence and drug kit number. The Randomize function is available to help you create the rule. For more information, see Randomize (in the Rules Reference Guide).
  • The Patient Number and Randomization items cannot be on the same section or form. If one item is on a section, the other item is allowed to be outside the section on the same form.

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