Management of Investigational Drugs

For more information on the management of investigational products, visit the ORC Regulatory Affairs webpage.

Guidance on the Management of Investigational Drugs

Investigational Drug Management Overview
CGMP Compliance Decision Tree and Regulatory Resources
Manual of Operating Procedures: Investigational Drug Management
Investigational Drug Service Checklist (Department of Pharmacy)
Investigational Drug Management Checklist (Clinical Research Sites)

Frequently Asked Questions

Delegation for Investigational Drug Management
Blinding of Investigational Drugs
Prescriptions and Drug Orders for Investigational Drugs

Standard Operating Procedures (SOP) Templates

Investigational Product Management (Clinical Research Sites)
Investigational Drug Service (in the Dept of Pharmacy)

Investigational Drug Binder Logs

Investigational Drug Binder

Binder Tabs

Study Feasibility & Initiation

ID Planning Worksheet
Delegation of Responsibilities Log
Monitoring Log
Protocol-specific Guidelines for Investigational Drug Management

Procurement, Accountability & Storage

Drug Accountability Log
Temperature Log
Temperature Excursion Report

Preparation & Dispensation

Study Drug Order/Request Form
Randomization Request Form
Subject-Specific Dispensing Record
Compounding Log for Encapsulation
Repackaging Record
Dispensing Label (2″ x 4″)
Drug Pickup or Receipt Record
Drug Dispensation by Mail Record
Drug Distribution or Transfer Record

Subject Safety and Compliance

Subject Emergency Cards
Subject Study Drug Calendar

Final Disposal

Subject Drug Compliance Record
Drug Return to Pharmacy Record
Drug Return to Sponsor Record
Drug Disposal Record