Safe Shipping of Regulated Materials for Clinical Research

Safe Shipping of Regulated Materials for Clinical Research

Safe Shipping of Regulated Materials for Clinical Research

$99.00

Learn the essential skills to safely and compliantly ship biological materials used in clinical research. This course covers DOT 49 CFR and IATA Dangerous Goods fundamentals, proper classification, triple-packaging, dry ice handling, labeling, documentation, and chain-of-custody best practices. Ideal for coordinators, lab techs, nurses, and site staff who prepare or support sample shipments.

Certificate valid for 3 years.

Course Name:

Safe Shipping of Regulated Materials for Clinical Research

Course Overview:

This course delivers practical, compliance-focused training on the safe and compliant shipment of biological materials and regulated substances used in clinical research. It provides a clear understanding of U.S. Department of Transportation (DOT 49 CFR) and International Air Transport Association (IATA) Dangerous Goods Regulations as they apply to clinical trial materials.

Learners gain essential skills in classification, triple-layer packaging, temperature-controlled shipments, dry ice requirements, labeling, documentation, and chain-of-custody best practices. This training complements the study-specific instructions provided by sponsors or central labs and demonstrates due-diligence training for audits and inspections.
The certificate is valid for 3 years.

Target Audience:

This course is designed for any clinical research professional who handles, prepares, or supports biological sample shipments, including:

  • Clinical Research Coordinators (CRCs)

  • Lab Technicians

  • Research Nurses

  • Investigators and Sub-Investigators

  • Clinical Research Associates (CRAs)

  • Clinical Trial Assistants (CTAs)

  • QA Specialists

  • Project Managers

  • Pharmacy Technicians

  • Site staff who prepare samples or work with pre-labeled shipping kits

If your role involves packing, labeling, verifying, or coordinating shipments from a site or facility, this training is appropriate for you.

Learning Objectives:

By the end of this course, participants will be able to:

  • Understand the regulatory foundations of DOT 49 CFR and IATA Dangerous Goods Regulations.

  • Correctly classify biological materials into Category A, Category B, Exempt Specimens, and GMOs.

  • Apply the triple-packaging system and follow P620/P650 requirements.

  • Prepare temperature-controlled shipments using dry ice or other cooling methods.

  • Apply legally required labels: UN hazard labels, orientation arrows, addresses, and emergency contact.

  • Complete essential documentation including Air Waybills, Shipper’s Declaration (as applicable), and Chain of Custody forms.

  • Prevent common errors that lead to shipment rejection, delays, or compliance findings.

  • Demonstrate safe handling practices, incident response (spill management), and proper record-keeping.

Course Structure:

The course contains five instructional videos totaling approximately 90 minutes, followed by a final assessment. Learners must complete all videos and score 75% or higher on the final quiz to receive a Certificate of Completion.

Course Breakdown:

Video 1 – Introduction & Regulatory Framework
Overview of the course, DOT vs. IATA foundations, compliance risks, penalties, and why proper shipping protects data integrity.

Video 2 – Classification of Biological Materials
Category A, Category B, Exempt Specimens, and GMOs; UN numbers; risks of misclassification; downloadable Classification Reference Guide.

Video 3 – Packaging Requirements & Temperature Control
Triple packaging demonstration; P620 and P650 rules; common packaging errors; dry ice (UN 1845) and lithium-powered temperature loggers (UN 3481)

Video 4 – Labeling & Documentation
UN labels, orientation arrows, addresses, documentation (Air Waybill, Shipper’s Declaration, Chain of Custody), and Kate’s label-application demo

Video 5 – Safe Handling & Compliance Essentials
Biosafety practices, PPE, spill response (Contain–Clean–Report), contingency planning, temperature excursions, record-keeping, and assessment preparation

Final Assessment:

A multiple-choice quiz covering all course modules.

  • Passing Score: 75%

  • Retakes Allowed: Yes

  • Certificate Validity: 3 years

Certification:

Upon successfully completing the assessment, participants receive a Certificate of Completion that includes:

  • A unique verification ID

  • A QR code for instant verification

  • Online certificate verification via gcptraining.com
    Valid for 3 years from the assessment date.

Course Benefits:

  • Learn how to ship clinical trial samples safely and compliantly.

  • Reduce risk of rejected shipments, delays, and regulatory findings.

  • Demonstrate due-diligence training for audits and sponsor oversight.

  • Improve the integrity of sample handling, chain of custody, and trial timelines.