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Randomization

The randomization feature of the InForm application enables users to assign a drug kit to a patient based on a randomization scheme that has been chosen for the trial. When randomization configuration is complete, one of the trial's forms contains a Drug Kit section. When a user clicks the Randomize button, the InForm application returns a drug kit number, along with associated information about the drug kit, in the Drug Kit section of the form. Before a user can use the randomization feature, you must perform the following configuration activities:

  1. Create a randomization sequence for each different list of drug kits used in the trial. The number of drug kit lists depends on the randomization method chosen:
    • Simple Central (Type 1)—The trial uses one list of drug kits. Each new patient is assigned the next sequential drug kit number on the list.
    • Central Stratified (Type 2)—The trial has multiple lists of drug kits. Each new patient is assigned to a drug kit list based on entered patient data. Then, the patient is assigned the next sequential drug kit number on that list.
    • Simple Site (Type 3)—Each site has a different drug kit list. Each new patient is assigned the next sequential drug kit number on the list for the patient's site.
    • Stratified by Site (Type 4)—Each site has multiple lists of drug kits. Each new patient is first assigned to the set of lists for the patient's site. Then, the patient is assigned to one of the site's drug kit lists based on entered patient data. Finally, the patient is assigned the next sequential drug kit number on that list.
  2. Add the Drug Kit section and randomization control to the form from which users will randomize patients.
  3. Write a randomization rule that determines the drug kit list from which to assign a drug kit number. This rule fires when a user clicks the Randomize button.
  4. Configure the randomization data source manager (COM object) to be used.
  5. Configure the format of each randomization sequence to be used.
  6. Set up a randomization source database for each trial.
  7. Create an ODBC connection for each randomization source database. You can do this manually or by using the PFAdmin utility.
  8. Configure each trial to use the randomization data source defined for it. This step is necessary only if you create the ODBC connection manually. If you perform that step by using PFAdmin, the utility performs both the DSN creation and configuration automatically.
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