The drug release process
Drug release is the process of preparing drug units for use and then making them available to central depots for shipment to local depots and sites.
Before releasing drug units, you must:
Drugs are released to IRT through these steps:
- Associate drug units with the depot.
This step identifies the serialized supplies or non-serialized drug units the depot can ship.
- Set up lots.
Create lots and set critical properties such as the expiration date, Do Not Ship (DNS) days, and Do Not Count (DNC) days.
- Associate drug units with a lot.
Identify the serialized or non-serialized drug units to associate with a lot.
- (optional unless set up during study design) Set up label groups.
Set up a new label group to assign countries to the label group.
- (optional unless set up during study design) Associate drug units with label groups.
Associate the drug units with the label group to control the countries to which the drug units can be shipped.
- (optional) Change expiration dates.
Extend the expiration date for drug lots, if necessary.
- (optional) Add manufacturing lots.
Set up manufacturing lots so you can track them through IRT.