Lots Number (PSP mode, By Lots)
A lot number is the tracking unit for investigational product in PSP-mode studies configured with Tracking = By Lots — one record represents a quantity of product from a single manufacturing lot, rather than one record per individual unit. Like Serial Numbers, a lot has no treatment-arm concept — PSP-mode studies are not randomized, so there is no Study Group to assign.
Navigate: IMP → Products → Lots number
What this should show: the Lots Number list for a PSP-mode study, with the table columns and filters described below.
Lots Number table columns
| Column | Description |
|---|---|
| Lot Number | Lot identifier |
| Product Name | Product this lot belongs to |
| Expiration Date | Only shown when the study uses expiration tracking |
| Quantity | Quantity of product remaining in this lot |
| Unit | Unit of measure |
| Site | Site currently holding this lot (if applicable) |
| Warehouse | Warehouse currently holding this lot (if applicable) |
| Created On | Date the lot record was added |
| Last Updated On | Date of last change; shows the created date if the record has not been updated |
There is no Study Group column and no Status column on this screen.
Filters available on this list: Product, Lot Number, Site, Warehouse, Expiry Status (Near Expiry / Expired), Expiration Date range, and Created Date range.
Add Lot Number (manual)
Click New Lot number to open the add dialog.
| Field | Behavior |
|---|---|
| Lot Number | Required text field. Enter the lot identifier |
| Product | Required. Select the product this lot belongs to |
| Expiration Date | Only shown when the study uses expiration tracking; optional when shown |
Click Submit to save the lot.
Editing an existing lot uses the same fields. Only the Study Administrator, System Administrator, and Unblinded RTSM Admin roles can add, update, or delete a lot record — the New Lot number button and the Edit/Delete row actions are hidden for any other role.
Export
Click the export icon in the toolbar to download the current Lots Number list as CSV or Excel for audit or verification.
Related Docs
- IP Codes — By Unique Serial Number
- Studies using Randomization mode instead: For Randomization Study — IP Codes