Manage expiration dates with lots

A kit can't be dispensed unless it has an expiration date, and you assign an expiration date to a kit by associating the kit with a manufacturing lot. This procedure also applies to rollover studies.

To understand which type of lot to create, see About manufacturing and blinded lots.

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

  1. Task 1. Create a manufacturing lot.
    1. Access your study in a specific mode.
    2. Along the top, click Supplies.
    3. Below the study name, click the Inventory tab.
    4. On the right, make sure that Lots is expanded.
    5. From the Create Lot drop-down, select Manufacturing Lot.
    6. Fill in the fields and click Create.

      Note:

      Custom country settings defined for a blinded lot override the default settings you may have specified for a manufacturing lot.
      Field Description
      Manufacturing Lot Title Enter a unique name for the manufacturing lot.
      Short Name Enter an alternative manufacturing lot label. For example, you might enter a short name if your organization's labeling conventions differ from the lot name supplied by the depot.
      Expiration Date Choose the expiration date for the kits in the manufacturing lot. If you're creating a manufacturing lot for devices that don't expire, you can choose a date that is very far in the future.
      Do Not Ship (DNS) Days Enter the number of days before the expiration date when a kit can no longer be shipped from a depot to a site.
      Do Not Count (DNC) Days Enter the number of days before the expiration date when the kit is no longer counted in a site's inventory.
    7. Assign kits to the manufacturing lot to manage their expiration dates.
  2. Task 2. (Optional) Create a blinded lot.
    1. Access your study in a specific mode
    2. Along the top, click Supplies.
    3. Below the study name, click the Inventory tab.
    4. On the right, make sure that Lots is expanded.
    5. From the Create Lot drop-down, select Blinded Lot and fill in the fields.
      Field Description
      Blinded Lot Title Enter a unique name for the blinded lot.
      Short Name Enter a short name for the blinded lot. This field is useful when multiple depots use the same lot and have different naming conventions. One depot can use the title, and another can use the short name.
      Expiration Choose the expiration date for the blinded lot. The date must be on or before the earliest expiration date of the manufacturing lots in the blinded lot.
      Release for Depot to Depot

      By default, this toggle is turned off.

      Turn the toggle on to allow your study team to ship kits at depots through a depot-to-depot shipment before kits are released at the sites. If there are any country-specific restrictions, a depot-to-depot shipment will be delivered at the depot without taking those country-specific settings into account.

      Do Not Count/ Do Not Ship Settings Specify a number in each column:
      • Do Not Count (DNC) Days: Enter the number of days before the expiration date when the kit is no longer counted in a site's inventory.
      • Do Not Ship (DNS) Days: Enter the number of days before the expiration date when a kit can no longer be shipped from a depot to a site.
      • Select countries: In the Do Not Count / Do Not Ship Settings section, click Select countries, and select the countries you want to specify custom DNC and DNS values for. Click the plus icon (+) to add a new row where you can customize these values for a different country.

        Note: Custom country settings override any default settings you may have specified.

    6. If you know the manufacturing lots that you want to combine into the blinded lot, select the manufacturing lots. Otherwise, combine manufacturing lots into the blinded lot later.
    7. Click Create.
Remember that you can update the expiration date for a manufacturing lot or a blinded lot at any time. After a lot expires, its kits are no longer distributed to sites or dispensed to subjects.