For shared IMP settings that apply to both Purpose-of-use tracks, see IMP Setup — Overview. For the Randomization track, see IMP Setup — Randomization Mode.
Overview
This track applies when Purpose of use is set to PSP (Patient support program) on the IMP configuration page. Use it for non-randomized dispensing workflows — studies that dispense one or more licensed investigational products without a Randomization module assigning treatment arms — or for any study that requires more than one investigational product.
If the study instead dispenses product against a Subject's randomized treatment arm, use Randomization Mode.
Settings Reference — PSP Mode
| Setting | Effect | Roles Affected |
|---|---|---|
| Multiple products supported | PSP mode allows registering and dispensing more than one investigational product per study. This is not available in Randomization mode, which is limited to one product. | Study Administrator, System Administrator |
| Tracking | All three tracking options are available: By Lots, By Unique Serial Number, or no tracking. The choice is not locked, unlike Randomization mode. | Study Administrator, System Administrator |
| Dispensing section label | The dispensing section is titled Dispensing Events & Schedule in this mode (Dispensing Medication for Randomization in Randomization mode). | Study Administrator, System Administrator |
Dispensing Events & Schedule
This section links each product to the CRF event(s) where dispensing is recorded. For the day-to-day dispensing workflow — selecting a product at the time of dispense and how dispense records are edited — see Dispenses — PSP Mode.
Editing an existing PSP dispense record requires the user to provide a Reason for change. See Dispenses — PSP Mode for the full editing workflow.
Study Administrator, System Administrator.