About manufacturing and blinded lots

In a study, you may have to create both manufacturing and blinded lots. Before creating your lots, you should understand the difference between these two lot types.

Manufacturing lots

You must use this type of lot in every dispensing study. Kits in a manufacturing lot share an expiration date, and you must create at least one manufacturing lot in each required study mode (Testing, Training, or Production) so that you can assign an expiration date to kits in Oracle Clinical One Platform.

You typically create a manufacturing lot before a study goes live and as needed during the study conduct period, such as when a new batch of product is released.

Blinded lots

Creating blinded lots is optional. You may choose to combine one or more manufacturing lots into a blinded lot for the following reasons:

• To monitor batches of kits while protecting the study blind.
• To organize kits in multiple groupings.

Create a blinded lot in Production mode if the study or organization requires blinded lot numbers. You can also create a blinded lot in Training mode if you want users to be able to practice the end-to-end business process.