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Activate/Inactivate arm for subject allocation

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

In IWRS, you can inactivate a specific arm within the randomization scheme to cease subject allocation for it. This action is reversible, and if your study requirements change, you can activate the arm again and continue subject allocation. This functionality allows for additional flexibility in the randomization scheme already in progress, eliminating the need to create new schemes to suit the evolving conditions of the clinical trial.

Important

To activate or inactivate the arm, change your randomization scheme status to Draft or Suspended, otherwise, the functionality is unavailable.

To activate or inactivate an arm for subject allocation

  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
    Figure 1. Selecting period

  4. In the period configurator, drill down the explorer tree and expand the randomization scheme of your interest. Then select Result notepad_icon.png.

    Accessing randomization result
    Figure 2. Accessing randomization result

  5. On the page that opens, select the Distribution tab and from the list of arms, locate the one that you want to activate or inactivate, then select one of the actions as follows.

Upon confirmation, your arm is activated or inactivated for subject allocation within the randomization scheme.

In this section:

A participant who is enrolled in a clinical trial and assigned to the site.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.