How do I manage expiration dates and replenish stock to prepare for imminent expiration dates?
A few settings help you manage the expiration dates of kits.
Setting | Description |
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Do Not Dispense (DND) Days |
What you specify Number of days that a kit can be in a subject's hands before the kit expires. When you set it A study designer typically specifies the value for the kits in each visit while defining the dispensation schedule. Details When planning this setting, consider when a subject will consume the investigational product. For example:
If your organization has a standard time buffer, add the days in the buffer to the number of days the subject will consume the product from the kit. For a buffer of 60 days:
|
Do Not Count (DNC) Days |
What you specify Number of days before the expiration date when the kit is no longer counted in a site's inventory. When you set it When you create a blinded lot and a manufacturing lot. If a manufacturing lot is part of a blinded lot, the expiration date of the blinded lot takes precedence. For a blinded lot, you can choose between setting this as the default value for all countries in your study, setting a specific default for selected countries in your study, or both. Custom values you specify for certain countries take precedence over what you specified as your default value. You can adjust this setting at any time. Details This setting helps you resupply a site before stock expires. This value is typically higher than the highest DND Days value. |
Do Not Ship (DNS) Days |
What you specify Number of days before the expiration date when a kit can no longer be shipped from a depot to a site. When you set it When you create a blinded lot and a manufacturing lot. If a manufacturing lot is part of a blinded lot, the expiration date of the blinded lot takes precedence. For a blinded lot, you can choose between setting this as the default value for all countries in your study, setting a specific default for selected countries in your study, or both. Custom values you specify for certain countries take precedence over what you specified as your default value. You can adjust this setting at any time. Details This setting helps you meet safety standards by preventing a kit that will expire before it is consumed from being shipped to a site. This value is typically higher than the Do Not Count (DNC) value. |