Returns (PSP mode, No tracking)
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 = No tracking, a return is built product by product with a quantity only — there is no lot or serial number reference.
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)
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Click + New Return.
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Fill in the Return Information fields (Reference, From, To, Estimated return date, Note, Invoice(s)) — the same fields used regardless of tracking method.
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In the Products section, click Add Product. Every product configured for the study is offered, regardless of current on-hand stock at the site. Select a product and confirm — it is added as a row.
Screenshot pendingWhat this should show: the Draft return's Products table for a No-tracking PSP study, with two product rows showing Product, Unit, On hand, and an editable Quantity field.
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For each product row, enter the Quantity being returned directly in the table. The value is validated against the product's on-hand quantity at the site — it cannot exceed the On hand figure shown in the same row.
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Use Delete on a row to remove the product from the return.
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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 table: one row per product, with Product, Unit, and Quantity.
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 product is 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 product/quantity table 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 table appears with one row per product (Product, Unit, Quantity), and two numeric fields per row — Omitted and Damaged — for entering how many units were not received or arrived damaged. The combined Omitted + Damaged quantity for a product cannot exceed its returned quantity. 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 product/quantity table, now including Omitted and Damaged columns showing any quantities recorded in Step 4.
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.
A return can be created for any product configured for the study, but the quantity entered cannot exceed the product's current on-hand stock at the source site.
Related Docs
- Returns — By Lots
- Returns — By Unique Serial Number
- Studies using Randomization mode instead: For Randomization Study — Returns