Overview

The Investigator and Clinical Research Coordinator (CRC) are blinded site-level roles for clinical staff conducting the trial. In the context of IMP management, their primary role is to initiate dispense requests for enrolled patients — they do not handle physical IP movement.

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Blinding Status

Both Investigator and CRC are completely blinded to treatment arm assignment:

• Cannot see treatment arm or IP-to-arm mapping
• Cannot see IP code inventory
• Only creates requests — the Site Pharmacist performs the actual dispense

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IMP Dispense Request Workflow

When a patient is due for IP administration, the Investigator or CRC creates a dispense request:

1. Navigate to IMP → Dispense Requests
2. Select the enrolled patient and visit
3. Click Create Dispense Request
4. The RTSM system automatically assigns an IP kit based on the randomization schedule
5. The Site Pharmacist receives a notification and physically dispenses the kit to the patient

note

The Investigator / CRC never sees which IP kit is assigned or what treatment arm it belongs to. Only the Site Pharmacist performs the physical handoff.

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Key Restrictions

• Cannot see treatment arm or arm mapping
• Cannot access IP code inventory
• Cannot confirm IP receipts or submit resupply requests — those actions belong to the Site Pharmacist
• Cannot approve shipments or Delivery Orders

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Role Assignment

Investigator and CRC roles are assigned at the site level in Administrations → Users. Select the specific site in the Study/Site field.

Role Name in CDS	Persona
Investigator	Principal Investigator or Sub-Investigator
Clinical Research Coordinator	CRC / Study Coordinator

For the full permission matrix, see System Settings → Roles & Permissions.