1. Purpose

To ensure biological specimens are collected, labelled, processed, stored and shipped so that sample integrity, subject privacy and dangerous goods regulations are all satisfied.

2. Scope

Applies to all blood, urine, tissue and other biological specimens collected for protocol-required central laboratory testing, local safety testing, biomarker analysis or future research storage.

3. Responsibilities

• Laboratory Manager: Owns processing procedures, equipment qualification, and shipper certification records.
• Laboratory Technologists and Specimen Processing Technicians: Process, aliquot, label and store specimens per the laboratory manual.
• Certified Shippers: Package and document dangerous goods shipments in accordance with current IATA and DOT requirements.
• Clinical Research Coordinators and Research Nurses: Collect specimens in the correct tubes at protocol-specified times and document collection.

4. Definitions

Category B infectious substance

A biological substance not meeting Category A criteria, shipped under UN3373 with triple packaging.

Triple packaging

A primary receptacle, secondary packaging with absorbent material, and rigid outer packaging with required marks and labels.

Processing window

The protocol- or laboratory-manual-specified maximum time from collection to centrifugation, aliquoting or freezing.

Chain of custody

The documented, unbroken record of specimen handling from collection through receipt at the analysing laboratory.

5. Procedure

1. Review the laboratory manual before the first collection of each study and confirm tube types, volumes, processing windows, storage temperatures and shipping schedule.
2. Label every tube and aliquot with the study identifier, subject identifier, visit, collection date and time, and specimen type; never include the subject's name, address or medical record number.
3. Collect specimens in the protocol-specified order of draw and within the visit window, and document the actual collection date and time in the source document.
4. Transport specimens to the laboratory within the manual-specified interval, under the required temperature and light-protection conditions.
5. Centrifuge, aliquot and freeze within the processing window, using calibrated equipment and documenting the actual processing times.
6. Record specimen storage location to freezer, rack, box and position, and maintain continuous alarmed temperature monitoring with daily documented review.
7. Document and report any deviation from the processing window, storage temperature or labelling requirement as a deviation under CON-002, and notify the central laboratory.
8. Ensure every person who prepares, signs for or offers a shipment holds current IATA or DOT dangerous goods training appropriate to their function, renewed at the required interval and documented per TRN-001.
9. Classify each shipment correctly, in most cases as UN3373 Biological Substance Category B, and never ship a Category A substance without Laboratory Manager authorisation and specific training.
10. Package using validated triple packaging with sufficient absorbent material, and pack dry ice shipments with the required venting, quantity marking and UN1845 labelling.
11. Complete the shipping manifest and requisition forms with de-identified subject identifiers only, and include a copy inside the secondary packaging as required.
12. Ship only on days the receiving laboratory accepts deliveries, record the courier and tracking number, and notify the laboratory of the shipment the same day.
13. Confirm receipt at the analysing laboratory, resolve any discrepancy or damage report within two business days, and document the resolution.
14. Maintain the specimen tracking log and chain of custody records, and reconcile against the central laboratory inventory at each monitoring visit and at close-out.
15. At study close-out, ship, destroy or transfer remaining specimens per the protocol, the consent document and sponsor instruction, and document the final disposition.

6. References

• 49 CFR Parts 171–180 — US DOT Hazardous Materials Regulations
• IATA Dangerous Goods Regulations, current edition
• 21 CFR Part 312.62 — Investigator recordkeeping
• 45 CFR 164.514 — De-identification of protected health information
• TRN-001 Training & Qualification of Research Personnel

7. Revision History

• v2.0 · Jun 20, 2022 — Added dry ice and UN1845 handling.
• v3.0 · Sep 09, 2024 — Added chain of custody reconciliation at monitoring visits.
• v3.1 · Dec 01, 2025 — Clarified prohibition of identifiers on specimen labels.