Safe Shipping of Regulated Materials for Clinical Research

Safe Shipping of Regulated Materials for Clinical Research – Syllabus

Course Name: Safe Shipping of Regulated Materials for Clinical Research

Course Description: This course provides foundational training on the safe and compliant shipping of biological materials in clinical research. Participants learn how to classify samples, apply the triple packaging system, label and document shipments correctly, and follow safe handling and compliance practices that protect sample integrity, data quality, and patient safety. The course is aligned with U.S. Department of Transportation (DOT) requirements under 49 CFR and with IATA Dangerous Goods Regulations, and it gives clinical research professionals the essential knowledge to execute sponsor and central lab shipping instructions correctly. Upon successful completion, participants receive a Certificate of Completion valid for 3 years.

Important Scope Note: This course is designed to complement, not replace, the specific instructions and materials provided by your study’s responsible shipper. It is not the regulatory-mandated DOT or IATA Dangerous Goods training required for individuals who sign the Shipper’s Declaration for Dangerous Goods. Its purpose is to give site and study staff the foundational knowledge needed to perform their role effectively and to provide tangible proof of due diligence training for auditors and regulators.

Target Audience: This course is intended for anyone at an investigational site, research facility, or sponsor organization whose role involves managing, overseeing, or handling clinical trial samples and study materials for shipment. This includes lab technicians, study coordinators, research nurses, investigators and sub-investigators, QA specialists, Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Project Managers, Pharmacy Techs, Clinical Trial Managers, and researchers. It is appropriate for staff at pharmaceutical, biotech, medical device, and CRO organizations who support clinical trial logistics, even when the central lab or sponsor is the official shipper of record.

Learning Objectives: Upon completion of this course, participants will be able to:

• Describe the regulatory frameworks that govern shipping of biological materials in clinical research, including DOT 49 CFR and IATA Dangerous Goods Regulations.
• Classify biological materials correctly into Category A, Category B, Exempt Specimens, and Genetically Modified Organisms (GMOs), with their corresponding UN numbers.
• Apply the triple packaging system and follow the requirements of Packing Instructions P620 (Category A) and P650 (Category B).
• Apply correct labels, markings, and orientation arrows, and prepare required documentation including the Shipper’s Declaration, Air Waybill, and Chain of Custody form.
• Implement safe handling, temperature control, spill response, and contingency procedures consistent with site SOPs.
• Recognize common errors, the consequences of non-compliance, and the role of site staff in supporting the shipper of record.

Course Structure: The course consists of five videos covering the regulatory foundation, classification, packaging, labeling and documentation, and safe handling and compliance. A final assessment follows the videos. Participants must complete all videos and pass the final assessment with a minimum score of 75% to receive their Certificate of Completion. Retakes are permitted.

Course Breakdown:

• Video 1: Introduction and Regulatory Foundations – Why safe shipping matters in clinical research, the role of site staff in supporting the shipper of record, and an overview of DOT (49 CFR) and IATA Dangerous Goods Regulations, including the consequences of non-compliance.
• Video 2: Classification of Biological Materials – The four categories of biological materials: Category A (high-risk infectious substances, UN 2814 / UN 2900), Category B (routine diagnostic samples, UN 3373), Exempt Specimens, and Genetically Modified Organisms (UN 3245), with examples and common classification errors. Includes a downloadable Classification Reference Guide.
• Video 3: Packaging Requirements – The triple packaging system demonstrated step-by-step, Packing Instruction P620 for Category A, Packing Instruction P650 for Category B, and temperature control with dry ice (UN 1845) and lithium battery temperature loggers (UN 3481).
• Video 4: Labeling and Documentation – Required labels and markings, hazard labels and application best practices, the Shipper’s Declaration for Dangerous Goods, Air Waybill / Bill of Lading, Chain of Custody form, and the final compliance check before courier pickup.
• Video 5: Safe Handling and Compliance Essentials – Personal protective equipment, spill response (Contain, Clean, Report), temperature control during storage and transit, contingency planning for delays and temperature excursions, real-time tracking, record-keeping, and assessment readiness.

Final Assessment: The assessment covers all course modules. A score of 75% is required to pass. Retakes are permitted.

Certification: Upon successful completion of the assessment, participants receive a Certificate of Completion, valid for 3 years from the date of completion. Each certificate carries a unique ID and QR code for online verification.

Course Benefits:

• Build foundational knowledge of DOT and IATA requirements as they apply to site and study staff.
• Reduce the risk of shipment rejections, sample loss, and trial delays caused by site-level errors.
• Provide tangible proof of due diligence training for sponsors, auditors, and regulators.
• Receive a 3-year Certificate of Completion with a unique ID and QR code for verification.

Time to Complete: ~1 hour