Mark a kit that was dispensed in error or not dispensed to the subject

Sometimes a kit shows as dispensed in the system but never actually reaches that subject. For example, the subject left the site without it, or the wrong subject received it. In these cases, work with your CRA to decide the correction steps and update the kit status in the system.

An error in dispensation typically involves a specific dispensed kit not reaching its intended recipient. Some scenarios involve multiple kits or subjects. For example:

Case	Description
The subject leaves the site without the kit that was dispensed in the system.	If this happens and the subject cannot recover the kit that was left behind, you simply need to replace the kit in the system with Not Dispensed to Subject as the reason, which automatically updates the kit status as Not Dispensed to Subject.
The kit is dispensed to the wrong subject.	It may happen that someone at your site enters data for the wrong subject or visit, and then a kit that was meant for one subject is delivered to a different subject. For example, if subject 002's data was entered in 001's visit, and then the kit that was meant for subject 001 and is dispensed to subject 001 in the system, is actually delivered to subject 002 in error. In this case you must first replace the kit in the system for subject 001 with Not Dispensed to Subject as the reason. Then you must complete the visit with the correct data for the correct subject 002 and clear the incorrect data from subject 001's visit. Upon completing the visit and clicking the Dispense button, Oracle Clinical One Platform allocates a different kit for the subject (002) which gets added to the subject's dispensation history. Your 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 you must update the kit status accordingly.
The wrong kit is dispensed to the subject.	It may also happen that you dispense a kit in Oracle Clinical One Platform but delivered a different kit to the subject. For example, if Oracle Clinical One Platform indicated the dispensation of kit 1100 but the subject received kit 1001. Your CRA must evaluate the case and decide if the subject can keep the kit dispensed in error, or if the new kit needs to be dispensed instead. Then you must make sure kit statuses are updated accordingly.

For quick reference, here's how to use each status:

• If a kit is dispensed in the system but not received by the subject, mark it as Not Dispensed to Subject, regardless of whether it was an error or a new kit.
• Mark kits as Misallocated if delivered but not dispensed in the system, such as wrong kits or kits physically given to the wrong subject. Assign Misallocated kits to the correct subject's number, this way they get added to their dispensation history.

For specific guidance on each case, refer to What if a site user dispensed a kit in error?

Note:

The CRA, along with other members of the study team, must always evaluate each case individually to decide the exact next steps to follow. This decision takes into consideration the study blind, treatment arms, protocol, whether it is a titration dose, calculated dose, or fixed dispensation and any other processes established for the given study.

Want to see how to perform this task? Watch the video below.

1. From the Home page, access the study in a specific mode. For more information to determine where to work, see Access study modes and pages.
2. If a replacement kit needs to be dispensed, replace the kit for the subject whose kit was dispensed in error. See Dispense a replacement kit (for lost, damaged, or not dispensed kits) .
   For example, if a kit that was dispensed to subject 001 in the system was given to subject 002 by mistake, replace the kit for subject 001.

   This step allocates a new kit to that subject for dispensation. You may need to confirm dispensation.

   This process also automatically updates the kit with a status of Not Dispensed to Subject. Continue with the following steps only if you need to perform manual updates to the kit status.

   WARNING:

   • If you are not sure about whether to replace a kit or the following steps, ask your CRA or reach out to your Oracle point of contact.
   • If the dispensation of a replacement kit is required, you must replace a kit before updating its status in the site inventory. If you miss this step and update the kit status before replacing the kit, either marking it as Misallocated or Not Dispensed to Subject, the system won't allow you to later dispense a replacement kit for that subject.
3. Along the top, select Supplies.
4. Below the study name, select the Site Inventory tab.
5. Locate and select the kit.

   Tip:

   • If you have access to multiple sites in the study, select a site from the Site drop-down in the upper-right.
   • To filter the list of kits, in the Search by Kit Number field, enter the number of the kit that was dispensed in error, and press Enter.
6. On the right, below Inventory Management, select Update Kit.
7. From the Kit Status drop-down on the right, select the new status for the kit:

   Note:

   Kits in certain statuses can not be directly updated to the statuses described in this task. For more information see Allowed updates for inventory status.
   • Misallocated: if the kit was delivered in error to a subject. Whether it was a wrong kit delivered to the subject, or a kit was delivered to the wrong subject.

     Then select the subject that received the kit from the Subject Number drop-down and a visit if applicable. For example, if the kit was dispensed to subject 001 in the system, but the kit was actually delivered to subject 002 in error. Mark that kit as Misallocated and select Subject Number 002.

   • Not Dispensed to Subject: if at the end the kit was not dispensed to or used by any subject.
8. Enter a reason for change and select Update Kit.

• If the kit is Misallocated, it gets added to the dispensation history for the selected subject.
• If the kit is marked as Not dispensed to Subject, it is no longer associated with the subject and disappears form their dispensation history.