27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : COLLECTION, STORAGE & PROCESSING OF BIOLOGICAL SAMPLES

1 Definition

Biological samples include blood, urine, saliva, biopsies, or other human specimens collected for laboratory analysis.

Handling samples requires strict adherence to:

• Protocol
• Laboratory Manual
• IATA guidelines (for shipment)
• Site SOPs

2 Purpose

• To ensure sample integrity
• To avoid hemolysis, contamination, or degradation
• To meet central lab quality standards
• To maintain consistency across sites globally

3 CRC Responsibilities in Sample Handling

3.1 Pre-Collection Preparation

CRC must ensure:

• Subject fasting requirements met (if applicable)
• Correct labels printed with:
• subject ID
• visit number
• date & time
• Correct vacutainers/tubes ready
• Lab manual reviewed before every visit

3.2 Sample Collection

Phlebotomist collects sample using aseptic technique.
CRC verifies:

• correct tube type (EDTA/SST/Heparin/etc.)
• correct volume
• correct time window

3.3 Sample Processing

As per laboratory manual:

• Centrifuge at required RPM and time
• Aliquot plasma/serum using sterile pipettes
• Label secondary aliquot tubes
• Document processing timepoints

CRC ensures centrifuge calibration is current.

3.4 Sample Storage

Depending on protocol:

• Store at 2–8°C, –20°C, or –80°C
• Ensure temperature logs maintained
• Use temperature-monitored freezers
• Ensure sample boxes organized and labeled

If temperature excursion occurs:

• Notify sponsor immediately
• Quarantine samples until further instructions

3.5 Sample Shipment

CRC coordinates:

• packaging with dry ice (if required)
• placing temperature data logger
• preparing chain-of-custody form
• booking courier pickup
• ensuring IATA-compliant labelling

3.6 Documentation

• Sample collection log
• Processing log
• Storage temperature logs
• Shipment manifest
• Chain-of-custody records