secuTrial_recipes

Step-by-step recipes for tasks in secuTrial

View the Project on GitHub SwissClinicalTrialOrganisation/secuTrial_recipes

Implement an external randomization list

Note: Before implementing the randomization make sure you
      implemented the form in which the randomization 
      should be performed.
  1. Make sure that you are able to randomize in the CustomerAdminTool. Therefore:
    1.1 Select Administrator > select yourself and the specific Customer area.
    1.2 Mark the Checkbox “Randomisierung-Verwaltung (RV)” and “Randonummern-Freigabe pro Zentrum (RZ)”: This enables you to see the Randomization option in the AdminTool.

  2. In the FormBuilder:
    2.1 Go to Edit configuration, under “Randomization”: Select “configurable”.
    2.2 Navigate to the form/question in which you would like to implement a randomization.
    2.3 Create a new item: type: “Configurable Randomization Button”
    2.4 Algorithm: “External Randomization (with list import)”
    2.5 Mark the checkbox “Centre assignment”: The client should provide a randomization list that includes randomization numbers that are assigned to the centres (for multiple centre studies).
    2.6 Group (arms): Provide the group names (e.g. “Intervention” and “Control”).
    2.7 Ignore the “stratification” checkox.
    2.8 Leave a message: Inernal Title: Randomization, Trigger: Randomization, Title: Study_name: Randomization of <ADD-ID> to <RANDOM>, Notes: Text for automatic delivery is checked, contrains Add_ID, Centre and Participant Name and Email

  3. In the AdminTool (make sure the form you are incorporating the randomization into is in the visit plan):
    3.1 Go to the “Randomization” tab in the upper right corner.
    3.2 Click on “New randomization list”.
    3.3 Select your project.
    3.4 Upload your randomization list (csv-file): This should include the randomization number and the randomization group. For multi-centre studies the centre name should also be specified (the centre name should not be included in the csv-file). Prepare the file with only two columns (“Randomization number” and the “Randomization group”) and be aware of the centre order. Order your numbers by centre names! (example csv)
    For further help, read the recipe create_randomization_list.
    3.5 Now you can assign the randomization numbers to the centres.
    3.6 Under the specific centre in the AdminTool you can also assign the randomization numbers to the centre.