Delivery to Site (PSP mode — By Lots)
A delivery request transfers investigational product (IP) kits from a Site Pharmacy (acting as the local warehouse) to a Clinical Research Site. This page covers PSP (Patient Support Program) studies configured with Tracking method = By Lots, where product quantities are allocated to specific lot numbers instead of individual serial numbers.
Navigate: IMP → Transfer → Delivery to Site
- Study status must be Available.
- IP kits must already be received into the source Site Pharmacy — see Receipts — before they can be delivered to a site.
Delivery request list
The list shows every delivery request for the study:
| Column | Description |
|---|---|
| Reference | Delivery request reference number (sortable) |
| From | Source Site Pharmacy (warehouse) |
| To | Destination Clinical Research Site |
| Request by | Whether the request was created by the Sponsor or by the Site |
| Desired date of delivery | The requested delivery date |
| Delivery status | Current step in the delivery workflow (sortable) |
| Created On / Last Updated On | Sortable timestamps |
| Created By | User who created the request |
| Action | View |
Use Search to filter by reference or site name, or apply the Status, Created date, From, and To filters. Click the export icon in the toolbar to download the list.
Create a new delivery request
Click New Delivery Request (Sponsor) to open the wizard.
Step 1 — Delivery information
| Field | Description |
|---|---|
| Reference | Optional reference code for this delivery request |
| From | Source Site Pharmacy |
| To | Destination Clinical Research Site |
| Desired date of delivery | Expected delivery date. Click Now to use today's date |
| Note | Optional context about the delivery |
| Attachments | Optional supporting documents |
Choose products — PSP studies can carry more than one product. Add a row per product (Product, Unit — auto-populated, On hand — the site's current on-hand quantity for that product, Demand) and click More product to add additional rows. Demand cannot exceed the On hand quantity shown for the product.
Click Save to save the request in Draft status and proceed to Step 2.
Step 2 — Detailed Operation
Unlike the serial-number mode, PSP Lot mode does not use a dual-list picker. It uses a single expandable table, shared with the Site Receipts screen for this tracking type — only the column label changes with tracking type ("LOT number" here).
What this should show: the Detailed Operation table for a PSP Lot-mode delivery request in Draft status, with a product row expanded to show its child lot rows, and the New LOT number row action visible.
Understanding the table
| Row type | Columns shown |
|---|---|
| Product row (parent) | LOT number column shows the product name and unit; Quantity column shows allocated / demanded (e.g., 4/6) |
| Lot row (child, expandable) | LOT number, Quantity allocated to that lot, Expired date (if the study tracks expiration dates) |
Adding a lot
- On a product row, click New LOT number.
- In the dialog, the Product and Unit fields are pre-filled and read-only. Select a LOT number from the lots currently on hand at the source Site Pharmacy — Expiration date and On hand populate automatically from the selected lot.
- Enter the Quantity to allocate from that lot. The quantity cannot exceed the lot's On hand value.
- Click Save. The lot appears as a new child row under the product, and the product row's counter updates.
Repeat until the product's allocated quantity matches its demand. Use the row-level Edit action on a lot row to change its quantity.
To add another product entirely (beyond what was configured in Step 1), use Add product at the top of the table.
Confirming the selection
Once every product shows the required allocated quantity, click Delivery confirmation. An e-signature dialog opens — enter your Username (pre-filled) and Password, then click Confirm delivery. The request status changes from Draft to Prepared.
Click Reject to cancel the request at this stage (with an optional reason).
Step 3 — Warehouse Prepare
The Warehouse Manager reviews the confirmed lot allocation and physically prepares the kits for shipment.
| Action | Description |
|---|---|
| Delivery confirmation | Confirms the lots have been prepared and are ready to ship |
| Reject | Rejects the delivery request (with reason) |
Once confirmed, the request advances to Step 4 — On Delivery.
Step 4 — On Delivery
The kits are in transit to the Clinical Research Site. When the site receives the shipment, a site user opens Delivery Confirmation at Site.
| Field | Required | Description |
|---|---|---|
| Completion date of delivery | Yes | The date the delivery was physically received |
| Attachments | No | Supporting documents (e.g., delivery note) |
| Comment of delivery | No | Free-text remark |
| Shipping Error | No | Yes/No — whether anything was omitted or damaged in transit |
If Shipping Error = Yes, the dialog adds a discrepancy table listing each lot allocated to the delivery, with Omitted and Damaged quantity fields per lot. Enter the affected quantities (their sum cannot exceed the lot's allocated quantity), then enter your Username and Password and click Validate to confirm.
What this should show: the Delivery Confirmation at Site dialog with Shipping Error set to Yes, showing the per-lot Omitted and Damaged quantity table.
Step 5 — Validated
The request is marked Done. The page shows a read-only summary of the request across every stage — Sponsor selection, warehouse preparation, and the site's confirmation — including any omitted or damaged quantities reported in Step 4.
Delivery request statuses
| Status | Description |
|---|---|
| Draft | Request created; Sponsor is allocating lots (Steps 1–2) |
| Prepared | Lot allocation confirmed by Sponsor; Warehouse Manager is preparing shipment (Step 3) |
| On delivery | Kits are in transit (Step 4) |
| Done | Delivery confirmed at the destination site (Step 5) |
| Rejected | Request was rejected at a review step |
| Cancelled | Request was cancelled |
Who can act at each step
| Step | Action | Roles |
|---|---|---|
| 1 — Delivery information | Create the delivery request | Study Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager |
| 2 — Detailed Operation | Confirm delivery or Reject | Study Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager, Sponsor Manager |
| 3 — Warehouse Prepare | Confirm preparation or Reject | Study Administrator, Study Sponsor, System Administrator, Sponsor Supply Manager, Warehouse Manager |
| 4 — On Delivery | Confirm receipt at the site | Clinical Research Coordinator, Investigator, Study Administrator, Study Sponsor, System Administrator, Sponsor Supply Manager, Site Pharmacist |
For the full permission reference, see the Permission Matrix.
Related Docs
- Delivery to Site — By Unique Serial Number
- Studies using Randomization mode instead: For Randomization Study — Delivery to Site