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Returns

# Supply Chain
Last updated: 04/14/2026

Manage the return of investigational products (IP) from sites back to sponsors, other sites, or warehouses using the Returns feature in the ClinicalDataS IMP module.

Returns

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. Both the Site Pharmacist and the Sponsor/Admin can initiate a return request.

Navigate: IMP → Transfer → Returns

Returns list — Site Pharmacist view


Return workflow overview

A return request goes through up to seven stages before it is closed. The full status progression is shown below.

StageWho actsWhat happens
DraftSite Pharmacist or Sponsor/AdminReturn request created and can be edited
RequestedSite Pharmacist submitsSponsor is notified and can review
ApprovedSponsor/Admin approvesSite Pharmacist is notified to begin preparing
PreparingSite PharmacistSite confirms goods are ready and dispatched
On DeliveryIP is in transit
ReceivedWarehouse/DestinationReceiving party confirms receipt
ClosedSystemAll confirmations complete, return closed
QuarantinedIssues reported at receipt (e.g., missing or damaged items)

Returns list columns

ColumnDescription
ReferenceSystem-generated return identifier (e.g., RET-Boston Medical Research Center-00014)
FromThe site or location sending the IP
ToThe destination site pharmacy or warehouse
StatusCurrent return status (Draft / Requested / Approved / …)
Created OnDate and time the return was created
Last Updated OnDate and time of the most recent status change
Created ByUser who created the return request
ActionView — open the return detail page

Site Pharmacist workflow

The Site Pharmacist is responsible for creating, editing, and preparing return requests for their site.

Step 1 — Create a new return (Draft)

  1. Navigate to IMP → Transfer → Returns.

  2. Click + New Return in the top-right corner.

    New Return form

  3. Fill in the return information:

    FieldRequiredDescription
    ReferenceOptionalCustom reference number. If left blank, the system generates one automatically
    FromRequiredThe site initiating the return (pre-filled with your site)
    ToRequiredDestination — another site pharmacy or warehouse
    Estimated return dateRequiredExpected date of dispatch
    NoteOptionalReason for the return or any remarks
    Invoice(s)OptionalUpload supporting documents
  4. In the IP Codes section, click + Add IP Code to select the IP codes to return.

  5. Click Save to save as Draft. The return can still be edited at this stage.

Step 2 — Edit a Draft return

From the Returns list, click View on any Draft return you created.

Draft return detail — Site Pharmacist

  • Save — save changes without submitting.
  • Send Request — submit the return request to the Sponsor for review. This moves the status from Draft → Requested.
  • Cancel — discard unsaved changes.
info

Once you click Send Request, the return is locked for editing. The Sponsor must review and approve it before the next step.

Step 3 — Wait for Sponsor approval (Requested)

After submitting, the return status changes to Requested. You can view the return detail page, which shows the full return information and IP codes.

Requested return — Site Pharmacist view

The Sponsor will review the request and either Approve or Reject it.

Step 4 — Prepare for dispatch (Approved → Preparing)

When the Sponsor approves the request, the status changes to Approved and a Start preparing button appears.

Approved return — Start preparing

Click Start preparing to confirm that goods are being assembled. The status moves to Preparing.

Once the goods are ready and dispatched, confirm the shipment in the Return Confirmation (Site Staff confirm) section. This moves the status to On Delivery.


The Sponsor (Unblinded Supply Manager) has a global view of all return requests across all sites. The Sponsor can also create return requests directly.

Navigate to the same IMP → Transfer → Returns screen from the Sponsor account.

Returns list — Sponsor view

Review and approve a Requested return

  1. Click View on a return with Requested status.

    Requested return — Sponsor view

  2. Review the Return Information and IP Codes sections.

  3. Click Approve to approve the return, or Reject to reject it.

    • Approve → status changes to Approved; Site Pharmacist is notified.
    • Reject → status changes back to Draft; Site Pharmacist can edit and resubmit.

View an Approved return

Once approved, the Sponsor can see the return detail including the Return Confirmation (Admin confirm) section where they can add an admin-level confirmation note once the physical review is complete.

Approved return — Sponsor view

Create a return request (Sponsor-initiated)

The Sponsor can also initiate a return on behalf of a site. The creation form is the same as the Site Pharmacist's New Return form. When the Sponsor creates a return, it is created with status Approved by default — the Site Pharmacist will see a Start preparing button immediately.


Return Confirmation sections

A completed return has three confirmation records, visible on the return detail page:

SectionWho fills itWhen
Return Confirmation (Admin confirm)Sponsor / AdminAfter approving — confirms the return is authorized
Return Confirmation (Site Staff confirm)Site PharmacistWhen goods are ready and dispatched
Return Confirmation (Warehouse confirm)Receiving warehouse staffUpon receiving the shipment

Each section captures: Confirm date, Confirm by, and Comment.


Quarantined status

If the receiving warehouse finds discrepancies upon receipt (e.g., missing or damaged IP codes), they record the issues in the IP Shipping Error section. The return status changes to Quarantined.

Quarantined returns require follow-up investigation by the Sponsor before the IP codes can be written off or reconciled.


Prerequisite

Returns can only be created for IP codes that are available at the site. IP codes still in the Central Depot or that have not yet been assigned to a receipt cannot be returned through this workflow.