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Add subject to balance calculation

From the Subject Information tab, you can view and manage various details about the selected subject. One such option is to add the subject back to the balance calculation in the randomization process if they were previously removed.

This means that if the subject is randomized according to the dynamic randomization scheme, you can configure the system to stop accounting for this subject when running the arm selector and randomizing the subsequent study participants. This can be done for subjects that do not receive treatment or are excluded (discontinued) from a study. However, if there is a need to revert this action, you can always add the subject back to the balance calculation.

To add a subject to balance calculation

  1. In the IWRS application header, select the SUBJECT tab.

  2. From the Subject List page that opens, select the needed site and subject.

    Selecting site and subject
    Figure 1. Selecting site and subject

  3. From the Subject Information page that opens, select ADD TO BALANCE CALCULATION add_to_balance_calc_icon.png.

    Adding subject to balance calculation
    Figure 2. Adding subject to balance calculation

  4. In the Add to Balance Calculation dialog that appears, select confirm_button_white_red.png to confirm your action.

    Confirming subject inclusion in balance calculation
    Figure 3. Confirming subject inclusion in balance calculation

Upon confirmation, the subject is added back to the dynamic randomization balance calculation. Now when randomizing subsequent participants, the system accounts for this subject allocation and factors.

In this section:

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

A randomization method that adjusts the allocation probabilities based on the current distribution of participants. Thus, when each subject comes to the study, the system assesses their compliance with established factors, evaluates the existing patient groups and site imbalance, and allocates the new patient to the most imbalanced group. Unlike permuted block randomization, dynamic randomization does not involve the predefined randomization list and offers more adaptivity to achieve arm balance at all times.

A component of the dynamic randomization algorithm that determines the treatment arm to which a new participant is allocated based on certain predefined criteria or rules.