Unscheduled dispensation and subject-site inventory

Purpose

Perform an authorized additional dispensation without completing a scheduled visit or changing the subject's original assignment.

Prerequisites

The Account Administrator enables additional/unscheduled dispensing in Study Design's Visit Schedule through the permitted save or amendment workflow. The subject must be randomized, the study active, and the user authorized for Dispense.Execute and the subject's site.

Section 1: Enable the protocol option

1. Open Studies & Design and the study's Design tab.
2. Locate Visit Schedule and enable the additional/unscheduled dispensation toggle.
3. Save through the approved design or live-study amendment workflow and confirm success.

Disabling the option removes permission to create new unscheduled dispensations; it does not erase issued-kit history.

Section 2: Dispense an additional supply

1. Open the subject and select Unscheduled dispensation in the Visit drop-down.
2. Enter the mandatory Dispensation date and Reason. The date cannot be in the future or before randomization.
3. Select an Investigational Product and quantity, from 1 to 1,000 per product row.
4. Use Add product for a different IP if required. Already selected products are excluded from the other drop-downs; the header appears once and Add product disappears when options are exhausted.
5. Click Dispense and read the result. Treatment allocation must match the subject's applicable assigned arm; do not substitute another arm's kit.
6. Review the issued kits and perform the separate physical verification procedure.

Successful issuance is recorded as Unscheduled 1, Unscheduled 2 and so on. Scheduled visit completion is unchanged. Product names and treatment information depend on blinding permissions.

Section 3: Read Site inventory under Details

The Subject page shows available site stock by IP, its quantity and total. It counts physical packages/balance quantities, not tablets per package. Blinded users see treatment stock merged into a masked entry. Available inventory is not a guarantee that those kits are eligible for this subject.

Troubleshooting: insufficient eligible supply

Check the correct site, product/current arm, released lot, expiry buffer, unassigned stock and packaging/master linkage. Depot and in-transit stock cannot be dispensed until site receipt. In the legacy master-linked path, kits can be restricted to the subject's exact randomization number: another available kit in the same arm may still be excluded. Site-block allocation has its own eligible matching-arm rules. Escalate to the authorized supply manager; do not relabel kits, rewrite assignments or change status to bypass the checks.

A shortage in any requested product prevents a successful additional dispensation. Reconcile the result before retrying. See dispensing and physical verification and site/depot supply review.