Returns (PSP mode, By Unique Serial Number)
A return records the transfer of unused, expired, damaged, or excess investigational product (IP) from a site back to the sponsor or a central warehouse. In PSP studies configured with Tracking = By Unique Serial Number, a return is built product by product, and each product carries a set of individually tracked serial numbers.
Navigate: IMP → Transfer → Returns
Who can act at each stage
| Stage transition | Action | Button | Roles |
|---|---|---|---|
| Create / edit Draft | Create or edit a return | New Return / Save | Clinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator |
| Draft → Requested | Submit for review | Send Request | Clinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator |
| Requested → Approved | Approve | Approve | Study Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager |
| Requested → Rejected | Reject | Reject | Study Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager, Warehouse Manager |
| Approved → Preparing | Confirm goods are being assembled | Start preparing | Clinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator |
| Preparing → On Delivery | Confirm shipment has been dispatched | Ready to ship | Clinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator |
| On Delivery → Received / Quarantined | Confirm receipt at the destination | Receive | Study Administrator, System Administrator, Warehouse Manager |
| Draft only | Cancel the request | Delete (list action) | Study Administrator, System Administrator, Warehouse Manager |
| Received / Quarantined → Closed | Final verification | Verify all detail | Study Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Unblinded Pharmacist, Sponsor Supply Manager |
Clinical Research Coordinator, Investigator, Site Monitor, Study Monitor, and several other roles have read-only access to the return list and detail pages at every stage.
Step 1 — Create a return (Draft)
-
Click + New Return.
-
Fill in the Return Information fields (Reference, From, To, Estimated return date, Note, Invoice(s)) — the same fields used regardless of tracking method.
-
In the Products section, click Add Product. Only products with serial numbers currently Available and eligible for return at the source site are offered. Select a product and confirm — it is added as a row with an empty Serial Number column (shown as
--).
Screenshot pendingWhat this should show: the Draft return's Products table for a By-Serial-Number PSP study, with two product rows, one showing a populated Serial Number column (a comma-separated list) and the other still showing
--. -
Click Edit Serial Number on the product row to open the serial number picker. This is the same dialog used to add serial numbers in Randomization mode, but scoped to the one product on that row: select from the available serial numbers using the checkboxes, search by serial number, or Select all, then click Submit.
-
The Serial Number column now shows the selected serial numbers as a comma-separated list. Reopen Edit Serial Number at any time before submitting to change the selection. Use Delete on the row to remove the product (and its serial numbers) from the return.
-
Click Save to keep the return as Draft, or Send Request to submit it to the Sponsor. Submitting locks the return for editing until it is approved or rejected.
Step 2 — Sponsor review (Requested)
The Sponsor (or another approving role, see the table above) opens the return and reviews the Return Information together with the product review: one card per product, each showing the product name, unit, and its comma-separated list of returned serial numbers.
Click Approve or Reject. Both actions require a Comment by Admin and the acting user's Username and Password.
- Approve → status changes to Approved.
- Reject → status changes to Rejected. The return remains visible with the Sponsor's comment recorded; it is not automatically reopened for editing.
The Sponsor can also create a return on the site's behalf using the same New Return form described in Step 1. A Sponsor-created return is created directly in Approved status.
Step 3 — Site prepares and dispatches (Approved → Preparing → On Delivery)
- Once the return is Approved, click Start preparing to confirm the serial numbers are being assembled for shipment. Status moves to Preparing.
- When the goods are packed and ready, click Ready to ship. Enter the Shipping date and an optional Comment by site staff, then confirm with Username and Password. Status moves to On Delivery.
Each of these steps shows the Return Confirmation (Admin confirm) section and the same per-product serial number cards from Step 2.
Step 4 — Warehouse receives the shipment (On Delivery → Received / Quarantined)
Once the destination confirms physical receipt, click Receive. In the Return Confirmation (by Study Admin) dialog:
| Field | Description |
|---|---|
| Date received | Required |
| Comment by Warehouse | Optional |
| Shipping error | Yes / No |
If Shipping error is set to Yes, a checklist appears for each product on the return: two side-by-side lists of its returned serial numbers, one for Omitted (not received) and one for Damaged. Check each serial number under the applicable list — a serial number can only be marked under one of the two. If no errors are reported, status moves to Received; if errors are reported, the return moves to Quarantined and requires follow-up before it can be closed.
Step 5 — Final verification (Closed)
On the return detail page, all three confirmation records are shown together — Return Confirmation (Admin confirm), (Site Staff confirm), and (Warehouse confirm) — followed by the per-product serial number cards. If a shipping error was reported in Step 4, a Shipping Error panel appears below each affected product's card, listing its Omitted and Damaged serial numbers separately.
Click Verify all detail to confirm the physical count matches the system record and close the return. Status moves to Closed. This step applies whether the return arrived clean (Received) or was flagged (Quarantined) — Quarantined returns still require this final verification before they can be closed.
Returns can only be created for serial numbers that are Available at the site and eligible for return. A product with no eligible serial numbers at the source site is not offered in Add Product.
Related Docs
- Returns — By Lots
- Returns — No Tracking
- Studies using Randomization mode instead: For Randomization Study — Returns