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Lots and expiry described
A lot is a batch of drug units. Drug units are packaged in lots by the manufacturer.
With lots and expiry (expiration), you control the creation and management of the lots that are set up in IRT. You set the expiration date for drug units by using key properties such as Do Not Ship (DNS) and Do Not Count (DNC) dates. The expiration is applied to all units in the lot, but the sponsor can modify these dates as needed in case of re-labeling.
The expiration date is based on GMT time in IRT, and drug units expire after 23:59 of the expiration date.
This table defines key dates in the lots and expiry process.
Time frame |
Definition |
|---|---|
Do Not Ship (DNS) |
The minimum number of days before the expiration date from which a supply order can be requested from a depot. Calculation: Current Date < Lot Expiration Date – DNS days Example: If the lot expires on July 12, and the DNS value is 10 days, the last possible ship date is July 2. |
Do Not Count (DNC) |
The minimum number of days before the expiration date from which drug units can be counted as available by the system at a site. This is the date the lot is replaced with new drug units. Calculation: Current Date < Lot Expiration Date – DNC days Example: For supplies that expire on July 12 with a DNC value of 8 days, supplies are not counted in the site inventory resupply calculation after July 3. |
Do Not Dispense (DND) |
The number of days before the expiration date from which drug units can be dispensed to a subject. These numbers are specific to each study's visit schedule and are available in the study documentation. Calculation: Current Date < Lot Expiration Date – Days from Expiry (DND) Example: For supplies that expire on July 12 with a DND value of 5 days, drug units are not dispensed to subjects after July 6. Notes:
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