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Change randomization scheme status

Randomization helps you avoid potential bias in the selection and allocation of subjects arising from the predictability of treatment assignments.

In IWRS, you can configure randomization within a cohort according to two methods—permuted block or dynamic randomization. For both these methods, you need to configure a randomization scheme—a plan according to which subjects enrolled in a study are randomized and receive treatment.

Since multiple randomization schemes can exist simultaneously within one cohort, you can manage their statuses to determine which of them is currently ongoing, is being configured (drafted), already closed or terminated, and so on.

To change the permuted block randomization scheme status

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. On the page that opens, in the left pane, select the Period subtab.

  3. In the Period List table that appears, locate the period of your interest. Then in the Period Name column, select the value to open the period configurator.

    Selecting period to configure
    Figure 1. Selecting period to configure

  4. In the period configurator, drill down the explorer tree and select Randomization List.

  5. In the Randomization List table that appears, locate the scheme for which you want to change status. Then from the Status column, expand the dropdown list and select the needed status as explained in the following table.

    Selecting PB randomization scheme status
    Figure 2. Selecting PB randomization scheme status

    Status

    Details

    Draft

    Represents the default status of the added scheme. The schemes with such statuses can be modified in terms of configurations or deleted.

    You cannot change the status to Draft if at least one subject is already randomized according to this scheme.

    Receiving error for draft status
    Figure 3. Receiving error for draft status

    Ongoing

    Represents that the ongoing scheme is currently used for randomization in IWRS and EDC. The schemes with such statuses cannot be modified or deleted.

    Completed

    Represents that the study for which this randomization has been created is over. The schemes with such statuses can be modified or deleted if no subjects are randomized according to them.

    Terminated

    Represents that the randomization scheme is terminated. The schemes with such statuses can be modified or deleted if no subjects are randomized according to them.

    Suspended

    Represents that the randomization scheme is suspended. The schemes with such statuses can be modified or deleted if no subjects are randomized according to them.

    Closed

    Represents that the randomization scheme is closed as it is no longer needed for some reason. The schemes with such statuses can be modified or deleted if no subjects are randomized according to them.

  6. In the Status Change Reason dialog that opens, enter the reason for your action.

    Providing status change reason
    Figure 4. Providing status change reason

  7. Select save_button_red.png to confirm your action.

Once saved, the status of the randomization scheme is updated.

In this section:

A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.