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Reverse subject phase change

With the Reverse option, you can undo the latest change of subject phase if it has been performed by mistake. For all active subjects, you can reverse the phase to the previous one.

For instance, you have changed the subject phase to screen failure, but in reality, the subject has passed the screening and must be enrolled. Thus, you can reverse the phase change.

The reverse action can be applied to all subject phases—including discontinuation—except for the registration phase, as this is the initial one, and from it, you can only forward the subject further.

Important

When reversing the Randomization phase, the randomization number acquired by the subject before the reversal is put on hold and preserved for this subject in case they are randomized again.

The connection between the subject and their randomization number after the Randomization phase reversal can be broken by releasing the number from the subject manually.

To reverse the subject phase change

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

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

    Selecting site and subject
    Figure 1. Selecting site and subject

  3. On the Subject Information page that opens, select button_reverse.png.

    Selecting to reverse latest phase change
    Figure 2. Selecting to reverse latest phase change

  4. In the Reverse Reason dialog that opens, fill in the attributes as explained in the following table.

    Important

    The details you need to provide for action confirmation depend on the authentication method configured for you in the system—via SSO or via providing your login and password.

    Adding reason to reverse subject
    Figure 3. Adding reason to reverse subject

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Username

    A read-only field that represents the name of the user reversing the subject phase.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The button is only available if you use the authorization method via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The field is only available if you use the authorization method via SSO.

    Password*

    Enter the account password.

    The field is only available if you use the authorization method by providing your login and password.

    Reason*

    Enter the reason for reversing the subject phase.

    SAVE

    Select save_button_white_red.png to save the implemented changes.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the changes without saving.

    Important

    For security, the system logs you out after three failed attempts to confirm your identity with a password or code.

Once saved, the latest phase change is reversed and the subject returns to the previous phase.

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