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Dispenses

# For Psp Study

Record and view IP dispensing events for studies using PSP (Patient Support Program) mode, where site staff select the product at the time of dispensing and editing an existing dispense requires a Reason for change.

Dispenses (PSP mode)​

A dispense records the event when a site user gives investigational product (IP) to a study participant. In PSP (Patient Support Program) studies, there is no upstream randomization or system kit assignment: the dispense is initiated directly against the participant's event, and the site user selects which product to dispense from among the products configured for the study.

Dispensing in PSP mode is self-contained inside the participant's event — there is no separate confirmation step on another screen. See Where this appears on Transfer → Dispenses below for how the record shows up on the study-wide list.

Dispense flow​

  1. Open the participant's event. From the Subject workspace, open the event (CRF) that has IP products configured, and locate the dispensing section configured under Dispensing Events & Schedule.
  2. Review on-hand stock and demand. For each product configured on the event, the section shows the site's on-hand quantity and the demand configured for that event, to help the site user select the right quantity.
  3. Select the product(s) to dispense. A single event can carry more than one product line. Depending on the Tracking method configured for the study, the user provides:
    • By Lots — the lot number and quantity for each product (added via Create, then a lot is selected and a quantity entered).
    • By Unique Serial Number — the serial number(s) dispensed for each product.
    • No tracking — a quantity only, with no lot or serial reference.
  4. Enter dispensing details. Complete Dispensed Date (required) and Created By (required — the site user recording the dispense; this value also appears as Dispensed by in the confirmation dialog and on the dispense record). Notes is optional.
  5. Click Dispense (or Update Dispense if the event already has a recorded dispense).
  6. Confirm in the dialog. The confirmation dialog restates the Subject ID, Visit, Dispensed Date, Dispensed by, and Notes, together with the product and lot/serial breakdown. Check the confirmation statement ("I confirm the IMP has been physically handed to the subject and the quantities above are correct") and click Confirm dispense (or Confirm update when editing — see Editing a dispense below). The record is saved as part of this action; no separate Save step is required.
  7. Complete the record (optional). Once all products for the event have been dispensed, click Complete to mark the dispense record for that visit as final. After confirming ("I confirm the dispense record above is final and accurate"), the record becomes read-only.

Where this appears on Transfer → Dispenses​

Every PSP dispense also appears on the study-wide IMP → Transfer → Dispenses list, for reference — but that list has no separate confirmation step for PSP records. A PSP dispense shows there with status Dispensed as soon as it is saved (step 6 above), even before you click Complete; the Dispense/Report Issue row actions on that list do not apply to PSP dispenses (they are part of the Randomization-mode flow — see For Randomization Study — Dispenses). Use View on a row to open the read-only Dispense Details panel described below.

Dispense columns​

The Transfer → Dispenses list is shared across both modes, but the columns shown for PSP-mode studies differ from Randomization mode:

ColumnDescription
Subject IDParticipant who received the IP
VisitEvent the product was dispensed for
ProductProduct dispensed — selected by the site user at the time of dispensing, not fixed
QuantityQuantity dispensed for the product
Expiry DateExpiration date of the dispensed lot or serial-numbered unit, where tracked
Assigned DateDate the dispense record was created
NoteFree-text note recorded with the dispense
StatusDispense status
Dispensed DateDate the product was dispensed
Dispensed BySite user who recorded the dispense

There is no Study Group column: PSP dispensing is not blinded and is not tied to a randomization treatment arm.

Editing a dispense​

When a site user reopens an event that already has a recorded dispense and clicks Update Dispense, the confirmation dialog requires a Reason for change before the update can be saved. This is a free-text field — enter a short explanation of why the dispense record is being corrected (for example, a quantity correction found during a pharmacy recount).

Reason for change is required whenever an existing PSP dispense is edited; it is not shown when recording a dispense for the first time, and it is not required when using Complete to close out a record. The edit, together with the reason entered, is recorded in the event's Audit History.

View dispense detail​

Click a row in Transfer → Dispenses to open the Dispense Details panel. The Dispense Summary section shows:

  • Subject ID and Visit
  • IP Code Number (only where the study Tracking method is By Unique Serial Number)
  • Product
  • Expiry Date
  • Current Status
  • Requested Date and Created By
  • Note

The Audit History section lists the recorded changes to the dispense, including edits made with a Reason for change.

Prerequisite

IP stock for the selected product must be available at the site (delivered and receipt confirmed) before it can be dispensed. Unlike Randomization mode, no upstream randomization step or kit assignment is required — the product is selected by the site user at the time of dispensing, from the products configured for the event.

Studies using Randomization mode instead: For Randomization Study — Dispenses

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