Manage supplies

After defining randomization, clinical supply managers can define how to manage supplies in the study, including lists, lots and other features.

• Define settings for Testing mode first, so you can test and verify a study version using mock data.
• Configure settings for Production mode once you have verified that the study design and settings are working as expected.
• Configure Training mode settings to match those defined for Production mode, so that users who operate your study can get properly trained with the real study configuration using mock data.

• Generate a kit list
  You can generate a new kit list at any time, without creating a new version of a study. Create a kit list for Production and Training modes when you're ready to make the study live.
• Upload a kit list
  You can upload a new kit list at any time, without creating a new version of a study. Create a kit list for Production and Training modes when you're ready to make the study live.
• Deactivate a kit list
  Deactivate a kit list if you ever uploaded a kit list in error and don't want to upload or generate a new kit list with different kit or sequence numbers. This procedure applies to rollover studies, as well.
• 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.
• 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.
• Assign kits to a manufacturing lot
  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.
• Combine manufacturing lots into a blinded lot
  Creating blinded lots is optional. You combine one or more manufacturing lots into a blinded lot for one of two reasons: (1) to monitor batches of kits while protecting the study blind, or (2) to organize kits in multiple groupings. This procedure also applies to rollover studies.
• Understand how to manage kits from the same lot
  In a study, you may have to ship or dispense kits from the same lot. Before choosing between managing kits from the same or multiple lots, you should understand the difference between these two types.
• Create label groups
  A label group contains kits with the same label and ensures that kits are shipped to countries with the appropriate labels. Create label groups only if a country has special label requirements and you want to verify the complete end-to-end business process. This procedure also applies to rollover studies.