Protocol for Safe Handling and Shipping of Biological Specimens in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and compliant transportation of biological samples collected during Bioavailability (BA) and Bioequivalence (BE) studies, ensuring sample integrity, stability, and regulatory compliance.

Scope

This SOP applies to all study personnel involved in the collection, handling, packaging, labeling, and transportation of biological specimens, including Investigators, Study Coordinators, Laboratory Technicians, and Couriers.

Responsibilities

• The Investigator is responsible for ensuring that biological samples are collected, handled, and shipped in compliance with study protocols, regulatory requirements, and best practices for sample integrity.
• The Study Coordinator is responsible for coordinating sample collection schedules, preparing sample shipment kits, and ensuring that all necessary documentation and permits are obtained for sample transportation.
• The Laboratory Technician is responsible for processing, aliquoting, and labeling biological samples for shipment, ensuring proper packaging and documentation to maintain sample integrity during transit.
• The Courier is responsible for transporting biological samples from the study site to the designated laboratory or testing facility in accordance with shipping regulations, temperature controls, and delivery timelines.

Procedure

1. Develop procedures for the collection, handling, packaging, labeling, and transportation of biological samples, including blood, urine, saliva, and tissue specimens, in compliance with study protocols and regulatory requirements.
2. Provide training to study personnel involved in sample collection, processing, and shipping, including instruction on proper techniques, handling precautions, and documentation requirements for sample transportation.
3. Coordinate sample collection schedules with study visits, ensuring that samples are collected promptly, processed efficiently, and shipped in a timely manner to maintain sample integrity and stability.
4. Prepare sample shipment kits containing all necessary supplies and documentation for sample packaging, labeling, and shipping, including specimen containers, absorbent materials, temperature monitors, and shipping labels.
5. Process biological samples promptly after collection, aliquoting them into appropriate containers, labeling each sample with unique identifiers, and documenting sample volumes, concentrations, and processing dates.
6. Pack biological samples for shipment in accordance with shipping regulations and best practices for sample stability, ensuring that samples are protected from temperature fluctuations, physical damage, and contamination during transit.
7. Label sample containers and shipping packages with appropriate identifiers, including study codes, participant identifiers, sample types, and handling instructions, to ensure accurate sample tracking and processing.
8. Coordinate sample transportation with designated couriers or shipping carriers, ensuring that samples are delivered to the designated laboratory or testing facility within specified timelines and temperature conditions.
9. Monitor sample shipments in transit, tracking delivery progress, and temperature conditions using tracking systems or temperature monitoring devices, and intervene promptly to address any deviations or delays.
10. Document all sample transportation activities, including sample collection, processing, packaging, labeling, and shipping, in sample logs, shipment records, and communication logs, for audit trail purposes.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence

Documents

• Sample Collection and Handling Protocol
• Shipping Manifests and Documentation
• Regulatory Guidelines for Biological Sample Transportation
• Courier Service Agreements

Reference

International Air Transport Association (IATA) Dangerous Goods Regulations and relevant regulatory guidelines for the transportation of biological samples by air and land.

SOP Version

Version 1.0