Overview
The Site Pharmacist is a blinded site-level role responsible for receiving, dispensing, and managing investigational product (IP) at a clinical research site. This role cannot see treatment arm assignments at any time.
Responsibilities
- Receive IP deliveries — confirm receipt of IP kits shipped from the Country Warehouse
- Dispense IP to patients — dispense the RTSM-assigned IP kit when a dispense request is created by the Investigator or CRC
- Submit resupply requests — request additional IP stock when site inventory falls below the threshold
- Handle returns — process damaged or surplus IP returns back to the Country Warehouse
Blinding Status
The Site Pharmacist is completely blinded to the treatment arm:
- Sees IP codes (kit numbers) only
- Cannot see whether a kit is active treatment or placebo
- Cannot see any treatment arm mapping at any level
Notifications
| Event | Notification Received |
|---|---|
| Delivery Order dispatched to this site | ✅ Yes — delivery arrival alert |
| Dispense request created by Investigator / CRC | ✅ Yes |
| Resupply request approved by Supply Manager | ✅ Yes |
| Return request status update | ✅ Yes |
Key Workflows
1. Confirm Receipt of IP Delivery
When a Delivery Order arrives at the site:
- The Site Pharmacist receives a delivery arrival notification
- Navigate to IMP → Deliveries to view the incoming shipment
- Inspect the physical delivery and confirm all IP kits are received
- Click Confirm Receipt to close the delivery and update inventory
You must confirm receipt before the IP kits become available for dispensing.
2. Dispense IP to a Patient
When an Investigator or CRC submits a dispense request:
- The Site Pharmacist receives a dispense notification
- Navigate to IMP → Dispense to review pending requests
- Locate the RTSM-assigned IP kit for the patient
- Physically dispense the kit and click Confirm Dispense in the system
3. Submit a Resupply Request
When site stock falls below the study's minimum threshold:
- Navigate to IMP → Inventory
- Click Request Resupply
- Enter the quantity needed and submit
- The Unblinded Supply Manager is notified and approves or adjusts the request
4. Handle Returns
For damaged or surplus IP:
- Navigate to IMP → Returns
- Select the IP kits to return and enter the reason (damaged, excess, expired)
- Submit the return request
- The Country Warehouse Manager receives notification to accept the return
Role Assignment
The Site Pharmacist role is assigned at the site level in Administrations → Users. Select the specific site (e.g., Boston Medical Research Center) in the Study/Site field before assigning the Site Pharmacist role.
| Role Name in CDS | Scope |
|---|---|
Site Pharmacist | Assigned per site |
For the full permission matrix, see System Settings → Roles & Permissions.