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Returns — By Lots

# Returns

Step-by-step Returns workflow for PSP-mode studies tracking investigational product By Lots — the expandable Product-to-Lot table used to create a return, and the lot-level review shown at every approval step.

Returns (PSP mode, By Lots)​

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 Lots, a return is built product by product, and each product can carry one or more lots with an individual quantity.

Navigate: IMP → Transfer → Returns

Who can act at each stage​

Stage transitionActionButtonRoles
Create / edit DraftCreate or edit a returnNew Return / SaveClinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator
Draft → RequestedSubmit for reviewSend RequestClinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator
Requested → ApprovedApproveApproveStudy Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager
Requested → RejectedRejectRejectStudy Administrator, Study Sponsor, System Administrator, Unblinded Supply Manager, Sponsor Supply Manager, Warehouse Manager
Approved → PreparingConfirm goods are being assembledStart preparingClinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator
Preparing → On DeliveryConfirm shipment has been dispatchedReady to shipClinical Research Coordinator, Site Pharmacist, Study Administrator, System Administrator
On Delivery → Received / QuarantinedConfirm receipt at the destinationReceiveStudy Administrator, System Administrator, Warehouse Manager
Draft onlyCancel the requestDelete (list action)Study Administrator, System Administrator, Warehouse Manager
Received / Quarantined → ClosedFinal verificationVerify all detailStudy 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)​

  1. Click + New Return.

  2. Fill in the Return Information fields (Reference, From, To, Estimated return date, Note, Invoice(s)) — the same fields used regardless of tracking method.

  3. In the Products section, click Add Product. Only products that have at least one lot recorded at the source site are offered. Select a product and confirm — it is added as a row with no lots yet.

    Screenshot placeholder

    Screenshot pending

    What this should show: the Draft return's Products table for a By-Lots PSP study, with one product row expanded to show two lot rows underneath it, each with Lot, Unit, On hand, and Quantity populated.

  4. Expand a product row and click the + action (New LOT number) to open the New Lot number dialog:

    FieldDescription
    Product / UnitPre-filled from the row, read-only
    LotSelect from the lots available for this product at the source site. Selecting a lot auto-fills its expiration date (if the study collects expiration dates) and on-hand quantity
    QuantityEnter the quantity to return from this lot; validated against the lot's on-hand stock

    Submit to add the lot as a child row under the product. Repeat New LOT number to add further lots to the same product.

  5. Use Edit on a lot row to change its quantity, or Delete to remove it. Use Delete on a product row to remove the product and all of its lots from the return.

  6. 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, each expanded to show its lots with Product, Unit, Lot Number, Expiration Date (if collected), 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)​

  1. Once the return is Approved, click Start preparing to confirm the lots are being assembled for shipment. Status moves to Preparing.
  2. 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 lot-by-lot product 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:

FieldDescription
Date receivedRequired
Comment by WarehouseOptional
Shipping errorYes / No

If Shipping error is set to Yes, a table appears with one row per lot (Product, Unit, Lot Number, Quantity), and two numeric fields per row — Omitted and Damaged — for entering how many units of that lot were not received or arrived damaged. The combined Omitted + Damaged quantity for a lot cannot exceed the lot's 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 lot-by-lot product 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.

Prerequisite

Returns can only be created for lots that have on-hand stock recorded at the site. A product with no lots at the source site is not offered in Add Product.

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