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Authorizing and setting approvals for rollbacks

Before you identify editable fields in IRT, you must set up IRT to permit rollbacks. You can configure rollbacks differently for each type of transaction. For more information, see Visit rollbacks in the User Guide.

You cannot roll back a screening visit.

  1. Click Configurations (Configurations tab (main menu)).
  2. On the left, click Transaction Configuration.

    For descriptions of the fields on this page, see Transaction Configuration page.

  3. In the Transaction drop-down list, select the type of transaction for which you want to authorize rollbacks.
  4. In the Roll-Back settings section, select Allow Roll-back.
  5. Identify additional rollback settings that are specific to the transaction.
    • For randomization visits, select Re-use Randomization number to re-circulate the randomization number that had been applied to the subject prior to the rollback.

      This field appears only if the study is configured for forced randomization. Selecting this field reduces gaps between randomization numbers.

    • If the field is available, select Roll-back drug status to indicate that the status of the drug was not affected during the visit.

      For example, suppose the site user sees the error immediately after the transaction is completed. In this case, the drug units are never provided to the subject or removed from a temperature controlled environment. Since the status of the drug has not been affected, the approver can roll back the drug status.

  6. If a roll back requires approval:
    • Select the role for the first-level approver from the Roll-Back First Approver(s) list.
    • (optional) Select the role for the second-level approver from the Roll-Back Second Approver(s) list.

      You can select multiple approval roles by pressing the Ctrl key and then select the roles.

  7. Repeat steps 3-6 for each transaction type.
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