Mark kits that had a temperature excursion

During the course of a study, you may have to mark kits that had a temperature excursion either at the depot or at a site that you support.

Note:

If you are not responsible for testing kits after a temperature excursion, you don't have to perform this task. Instead, contact the clinical supply manager about testing kits that had a temperature excursion.

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

Identify kits that had a temperature excursion

1. Navigate to the Study Inventory tab. For step-by-step instructions, see Access the Study Inventory tab.
2. Click the type of kit that experienced a temperature excursion.
3. Above the kit list, use the filters to return only the kits you want to mark for testing:
   1. If you work at multiple depots, below Location, click Depots, and select your current location from the All Depots drop-down.
   2. Above the kit list, from the Status drop-down, select Available.
   3. To view kits from the same lot, select a blinded or manufacturing lot from the Lots drop-down.
   4. Above the kit list, select Sequence and narrow the range to the correct sequence numbers.
4. In the list, select the kits you want to mark for testing.
5. On the right, make sure Kit Settings is expanded.
6. Under Kit Settings, from the Status drop-down, select Pre-quarantined.
7. Click Update Kits.
8. In the confirmation window, select a reason for change and click Yes.

   Tip:

   Pre-quarantined kits can't be included in shipments. Only available kits whose expiration dates meet the shipping requirements can be included.
9. Repeat these steps for each kit type with a kit that had a temperature excursion.

Task 2. Update the status of kits after testing them

1. Navigate to the Study Inventory tab. For step-by-step instructions, see Access the Study Inventory tab.
2. Click the kit type of the kit that had a temperature excursion.
3. Above the kit list, use the filters to return only the kits you want to update:
   1. From the Status drop-down at the top of the page, select Pre-quarantined.
   2. If necessary, narrow the kits further by selecting Sites or Depots, under Location, and selecting the location of the kits from the All Sites or All Depots drop-down.
4. Update the kits that failed testing or were damaged in the process:
   1. Select the kits that failed testing or were damaged in the process.
   2. On the right, make sure Kit Settings is expanded.
   3. From the Status drop-down, select Quarantined.

      Tip:

      Quarantined is the end of life for a kit. Quarantined kits are not counted in a site's inventory.
   4. Click Update Kits.
   5. In the confirmation window, select a reason for change and click Yes.
5. Update the kits that passed testing and can be dispensed:
   1. Make sure that your filters are still set to only show kits with a status of Pre-quarantined.
   2. In the list, select the kits that passed testing.
   3. On the right, make sure Kit Settings is expanded.
   4. Below Kit Settings, from the Status drop-down, select Available.
   5. Click Update Kits.
   6. In the confirmation window, select a reason for change and click Yes.