Manage expiration dates with lots
You must create at least one manufacturing lot in each required study mode (Testing, Training, or Production) or you won't be able to dispense kits in those required study modes. You use lots to specify the expiration date for kits. Blinded lots are optional and allow you to combine one or more manufacturing lots.
Before you perform this task, consider the following notes:
- Create one manufacturing lot for each batch of kits. Grouping kits by batch helps you monitor and search for kits to ensure quality. If multiple batches have the same expiration date, name the lots appropriately so you can identify them.
- You can update the expiration date for a manufacturing lot or a blinded lot at any time. The blinded lot must always use the earliest expiration date of all its manufacturing lots.
- After a lot expires, its kits are no longer distributed to sites or dispensed to subjects.
For more information, see About manufacturing and blinded lots.
Want to see how to perform this task? Watch the video below.
- Create a manufacturing lot
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Note:
Follow the steps below to create a manufacturing lot in all of the required study modes: Testing, Training, or Production. To return to the Home page, in the upper right, click Home.- Navigate to the Study Inventory tab. For step-by-step instructions, see Access the Study Inventory tab.
- Expand the Lots side panel to the right of the page.
- From the Create Lot drop-down, select Manufacturing Lot.
- Fill in the fields and click Create. To view
tips for completing a field, click into the field.
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 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.
- Create a blinded lot
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Note:
Follow the steps below to create a manufacturing lot in all of the required study modes: Testing, Training, or Production. To return to the Home page, in the upper right, click Home.- On the Lots side panel, from the Create Lot drop-down, select Blinded Lot.
- Fill in the fields and click Create.
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. 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.
Parent topic: Manage expiration dates