Standard Roles Overview
ClinicalDataS uses role-based access control (RBAC) to manage what each user can see and do within a study. Roles fall into two blinding categories — Unblinded (can see treatment arm assignments) and Blinded (sees IP codes only, never treatment arm).
For the full permission matrix, see System Settings → Roles & Permissions.
Role Summary Table
| Role | Blinding | Typical Persona | Primary Responsibilities | Key Restrictions |
|---|---|---|---|---|
| Unblinded Supply Manager | 🔴 Unblinded | Sponsor / CRO Supply Chain | Manage shipments Central Depot → Country WH → Sites; view IP-to-treatment-arm mapping; approve resupply requests | Cannot access patient clinical data |
| Unblinded RTSM Administrator | 🔴 Unblinded | RTSM Vendor / CDS | Configure RTSM system; manage IP code list and treatment arm assignments | Must never be combined with Supply Manager role; cannot create shipments |
| Unblinded Pharmacist | 🔴 Unblinded | Country-level Quality Oversight | Quality oversight of IP at country warehouse; manage IP code inventory | Cannot ship directly to sites |
| Warehouse Manager | 🔵 Blinded | Country Warehouse Staff | Receive and confirm inbound stock; pick/pack/ship per Delivery Order; report damaged stock | Cannot see treatment arm — IP code only |
| Site Pharmacist | 🔵 Blinded | Site Pharmacy Staff | Receive IP at site; dispense per RTSM assignment; submit resupply requests; handle returns | Completely blinded to treatment arm |
| Investigator / CRC | 🔵 Blinded | Investigator or Clinical Research Coordinator | Create dispense requests for enrolled patients | Completely blinded to treatment arm; does not handle physical IP movement |
IP Code Visibility by Role
| Role | Sees IP Code | Sees Treatment Arm | Can Create Shipments | Can Dispense |
|---|---|---|---|---|
| Unblinded Supply Manager | ✅ | ✅ | ✅ | ❌ |
| Unblinded RTSM Admin | ✅ | ✅ | ❌ | ❌ |
| Unblinded Pharmacist | ✅ | ✅ | ❌ | ❌ |
| Warehouse Manager | ✅ | ❌ | ✅ (outbound) | ❌ |
| Site Pharmacist | ✅ | ❌ | ❌ | ✅ |
| Investigator / CRC | ❌ | ❌ | ❌ | ❌ (request only) |
Study-Level vs. Site-Level Roles
Roles are assigned at either the study level or a specific site within the study:
- Study-level roles — Unblinded Supply Manager, Unblinded RTSM Admin, Unblinded Pharmacist, Warehouse Manager. These users have access across the entire study.
- Site-level roles — Site Pharmacist, Investigator, Clinical Research Coordinator. These users are scoped to a single site.
When adding a user in Administrations → Users, select either the study or a specific site in the Study/Site field before assigning the role.