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Standard Operating Procedure for Sample Shipment and Chain of Custody

Purpose

The purpose of this SOP is to establish standardized procedures for the shipment of biological samples in clinical trials, ensuring integrity, confidentiality, and compliance with international guidelines such as ICH GCP, FDA, EMA, CDSCO, WHO, and IATA Dangerous Goods Regulations.

Scope

This SOP applies to all clinical trial personnel, including investigators, laboratory staff, couriers, and CROs involved in sample packaging, shipment, transport, and receipt. It covers temperature-controlled shipments, dry ice packaging, courier qualification, chain of custody documentation, and deviation handling.

Responsibilities

• Investigator: Ensures compliance with protocol requirements for sample shipment.
• Clinical Staff: Prepares, packages, and documents samples before shipment.
• Courier: Transports samples under validated, compliant conditions.
• Laboratory Staff: Verify receipt and integrity of samples upon arrival.
• CRA: Reviews shipment documentation during monitoring visits.
• QA: Audits shipment records and chain of custody compliance.

Accountability

The Sponsor is accountable for oversight of sample shipment procedures and vendor qualification. The Investigator is accountable for accurate pre-shipment documentation and chain of custody. QA is accountable for ensuring compliance with applicable regulations.

Procedure

1. Courier Qualification
1.1 Only couriers qualified and audited for biological sample handling may be used.
1.2 Maintain Vendor Qualification File with certificates and audits.

2. Packaging
2.1 Follow IATA Packing Instruction 650 for biological substances (Category B).
2.2 Use triple-layer packaging (primary container, secondary leak-proof container, outer package).
2.3 Label packages with “Biological Substance, Category B” and dry ice details (if applicable).

3. Pre-Shipment Documentation
3.1 Complete Sample Shipment Form (Annexure-1) for each shipment.
3.2 Document temperature monitoring devices inside packages.
3.3 Investigator or delegated staff signs Chain of Custody Log (Annexure-2).

4. Transport
4.1 Couriers must maintain specified temperature ranges (e.g., 2–8°C, −20°C, −80°C).
4.2 Couriers record each transfer point in the Chain of Custody Log.
4.3 Any delays or incidents must be documented in Shipment Deviation Log (Annexure-3).

5. Receipt of Samples
5.1 Laboratory staff verify integrity, labeling, and temperature conditions.
5.2 Document receipt in Sample Receipt Log (Annexure-4).
5.3 Notify Sponsor/Investigator immediately in case of discrepancies.

6. Chain of Custody
6.1 Maintain uninterrupted custody from collection site to laboratory.
6.2 All handovers must be signed, dated, and recorded.
6.3 QA verifies chain of custody completeness during audits.

7. Deviations
7.1 Record deviations (e.g., temperature excursion, courier delays) in Shipment Deviation Log.
7.2 Investigate deviations and initiate CAPA.

Abbreviations

• SOP: Standard Operating Procedure
• CRA: Clinical Research Associate
• QA: Quality Assurance
• CRO: Contract Research Organization
• IATA: International Air Transport Association
• CAPA: Corrective and Preventive Action

Documents

1. Sample Shipment Form (Annexure-1)
2. Chain of Custody Log (Annexure-2)
3. Shipment Deviation Log (Annexure-3)
4. Sample Receipt Log (Annexure-4)

References

• ICH E6(R2/R3) – Sample Handling and Transport
• FDA – Biospecimen Transport Guidance
• EMA – Clinical Trial Sample Shipment Requirements
• CDSCO – Biological Sample Handling
• WHO – Biospecimen Transport and Chain of Custody

Version: 1.0

Approval Section

Annexures

Annexure-1: Sample Shipment Form

Annexure-2: Chain of Custody Log

Annexure-3: Shipment Deviation Log

Annexure-4: Sample Receipt Log

Revision History

For more SOPs visit: Pharma SOP