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 in Testing mode
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. - 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.
Parent topic: Configure a study