1. If the subject cannot receive the original kit and a replacement kit needs to be dispensed, the site user must replace the kit for that subject using Not Dispensed to Subject as the reason. See Dispense a replacement kit for a kit that was lost, damaged or not dispensed to subject.
   • This will allocate a new kit to that subject for dispensation and add it to the subject's dispensation history. You may need to confirm dispensation.
   • Additionally, this will automatically update the old kit status as Not Dispensed to Subject, and the old kit will no longer be associated with the subject's dispensation history.

If you don't need to replace the dispensed kit and need to manually update the kit status, see Mark a kit that was dispensed in error or not dispensed to the subject.

1. The CRA must review the specific case and determine if the subject my continue as part of the study.
   • If the subject may not continue in the study:
     1. The site user must withdraw the subject. See Withdraw a subject.
   • If the subject may continue in the study:
     1. If the dispensation of a replacement kit is required, the site user must replace the kit for that subject using Not Dispensed to Subject as the reason. You may need to confirm dispensation. See Dispense a replacement kit for a kit that was lost, damaged or not dispensed to subject.

        This process automatically updates the old kit status as Not Dispensed to Subject . The new kit gets added to the subject's dispensation history and the old kit is removed.

     2. If the dispensation of a replacement kit is not required, the site user must update the kit status in the site inventory as Not Dispensed to Subject, for the kit that was dispensed in the system but not delivered to the subject.

        The kit will get removed from the subject's dispensation history.

     3. The site user must update the kit status in the site inventory as Misallocated, for the kit that was actually delivered to the subject in error.
        • When you mark the kit as Misallocated, select the subject number of the subject that received the kit, and a visit if applicable.

        The Misallocated kit will get added to the subject's dispensation history.

If you need to manually update the kit status as either Misallocated or Not Dispensed to Subject, see Mark a kit that was dispensed in error or not dispensed to the subject.

1. The site user must replace the kit for the subject that got the kit dispensed in the system. See Dispense a replacement kit for a kit that was lost, damaged or not dispensed to subject.

   For example, if the site user entered data for subject 001 in the visit for subject 002, the site user should replace the kit for subject 002.

   This will remove the old kit from the subject's dispensation history (as it was not dispensed to them) and add the replacement kit to it.

2. The site user must update the kit status in the site inventory as Misallocated, for the kit that was delivered to the wrong subject. See Mark a kit that was dispensed in error or not dispensed to the subject.
   • When you mark the kit as Misallocated, select the subject number of the subject that received the kit (001, as in the example).

   This will add the Misallocated kit to the dispensation history of the subject that actually received the kit.

3. The CRA must evaluate the case and determine if the subject that received the wrong kit may continue as part of the study.
   • If the subject may not continue in the study:
     1. The site user must withdraw the subject. See Withdraw a subject.
   • If the subject may continue in the study:
     1. The site user must enter the data in the correct visit for the correct subject.
     2. Upon completing the visit and clicking the Dispense button, Oracle Clinical One Platform allocates a different kit for the subject (001, as in the example). The CRA must decide whether to exchange the kit that is in the subject's hands (the one previously dispensed in error) with the new kit, or if the subject should not receive the new kit. Then update the kits status in the site inventory accordingly:
        • Any kit that is dispensed in the system but not received by the subject, whether it is the one dispensed in error or the newly dispensed kit, should get a status of Not Dispensed to Subject.
        • Any kit that is delivered to a subject but is not dispensed to them in the system, like the kit in the example that is dispensed in error to one subject in the system but physically delivered to a different subject, should get a status of Misallocated. The Misallocated kit must be assigned to the subject number of the subject that received the kit so that it gets added to their dispensation history.

1. The site user must update the kit status in the site inventory as Misallocated, for the kit that was delivered outside of the system. See Mark a kit that was dispensed in error or not dispensed to the subject.
   • When you mark the kit as Misallocated, select the subject number of the subject that received the kit.

Warning: Do not try to correct titration errors with manual dispensations and kit status updates. Manual misallocation of new kits for the desired titration response will most likely prevent dispensation for future visits using titration dispensation.

1. To dispense kits with the correct titration response, the site user should complete a new visit (most likely an unscheduled dispensation visit) with the correct response and dispense the new kits.
   • Reach out to your study team if your study design does not include unscheduled dispensation visits to address these scenarios. Then wait for instructions.
2. For the kit that was dispensed with an incorrect dose, the site user must update the kit status in the site inventory as Not Dispensed to Subject. See Mark a kit that was dispensed in error or not dispensed to the subject.

   This kit will get removed from the subject's dispensation history.

3. (Optional for unblinded kits). The Clinical Supply Manager (CSM) may change the kit status of the originally dispensed kits (kits dispensed in error) from Not Dispensed to Subject to Available, so they are available for later use in the study.

   Note: Some direct kit status transitions are not allowed and some others depend on your study role and permissions. For more information see Allowed updates for inventory status.