Returns (PSP mode)
A return records the transfer of unused, expired, damaged, or excess investigational product (IP) from a site back to the sponsor, another site pharmacy, or a central warehouse. Every return moves through the same set of statuses (Draft, Requested, Approved, Preparing, On Delivery, Received, Closed, and — if a shipping error is reported — Quarantined), but the screen used to select and review the returned product depends on the study's Tracking method.
Navigate: IMP → Transfer → Returns
An IP unit must already be at the site — delivered and receipt confirmed — before it can be included in a return.
Which guide applies to this study
Tracking is set once during IMP setup and cannot be changed after the study has recorded data — see IMP Setup — Choose Your Track to confirm the study's configuration.
| By Lots | By Unique Serial Number | No tracking | |
|---|---|---|---|
| Product selection at creation | Add one row per product, then add one or more lots to each | Add one row per product, then select the serial numbers for each | Add one row per product, then enter a quantity for each |
| What is added to the return | Lot number and quantity per lot, per product | Serial numbers per product, picked from a checklist | Quantity per product only — no lot or serial reference |
| Review screen (approval / prepare / receive / validate) | A table with one row per lot, grouped under its product | A per-product card listing the selected serial numbers | A table with one row per product |
| Shipping-error reporting at Warehouse receive | Numeric Omitted / Damaged quantity per lot | Checkbox list of serial numbers, split into Omitted / Damaged | Numeric Omitted / Damaged quantity per product |
For the full step-by-step workflow, open the guide for the study's configuration:
The roles that can create, approve, prepare, receive, and validate a return are the same across all three configurations — see the "Who can act at each stage" table on any of the three pages above. What differs by configuration is only the product-selection and product-review screen, not who is authorized to act.
Studies using Randomization mode instead: For Randomization Study — Returns