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“headline”: “SOP for Biological Sample Collection and Processing”,
“description”: “This SOP defines standardized procedures for the collection, labeling, processing, and documentation of biological samples in clinical trials, ensuring compliance with ICH GCP, FDA, EMA, CDSCO, and WHO requirements. It includes sample handling, centrifugation, freezing, and biospecimen chain of custody.”,
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Published on 23/12/2025
Standard Operating Procedure for Biological Sample Collection and Processing
| SOP No. | CR/OPS/082/2025 |
| Supersedes | NA |
| Page No. | 1 of 40 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish standardized, regulatory-compliant procedures for the collection, labeling, processing, storage, and documentation of biological
Scope
This SOP applies to all investigators, clinical staff, laboratory technicians, and CROs involved in the collection and processing of biological samples (blood, urine, saliva, tissue, genetic material) from subjects participating in clinical trials. It covers informed consent, aseptic collection, labeling, processing, storage, transport, documentation, and chain of custody.
Responsibilities
- Investigator: Ensures sample collection is ethically approved and compliant with consent.
- Clinical Staff: Performs aseptic sample collection and records procedures.
- Laboratory Technicians: Process and store samples under validated conditions.
- CRA: Verifies sample management compliance during monitoring visits.
- QA: Audits sample collection and processing records for GCP compliance.
- Courier/Vendors: Maintain sample transport integrity and document chain of custody.
Accountability
The Principal Investigator (PI) is accountable for ensuring compliance with regulatory guidelines for biological sample handling. Laboratory managers are accountable for sample processing and storage integrity. QA is accountable for oversight and inspection readiness.
Procedure
1. Informed Consent and Ethics
1.1 Ensure subjects have provided informed consent specific to sample collection, processing, and future use (if applicable).
1.2 Maintain consent forms in the Investigator Site File (ISF).
2. Sample Collection
2.1 Collect samples using aseptic techniques, minimizing pre-analytical variability.
2.2 Record sample type, volume, and collection time in Sample Collection Log (Annexure-1).
2.3 Use appropriate collection containers (vacutainers, sterile jars, tissue containers).
2.4 Apply subject ID labels immediately after collection.
3. Sample Processing
3.1 Process blood samples within 2 hours of collection (centrifugation at specified RPM and duration).
3.2 For tissue samples, fix or preserve as per protocol requirements.
3.3 Prepare aliquots where required and label each with subject ID, sample type, date, and time.
3.4 Document processing steps in Sample Processing Log (Annexure-2).
4. Sample Storage
4.1 Store samples at validated conditions (e.g., −20°C, −80°C, liquid nitrogen) as defined by protocol.
4.2 Maintain continuous temperature monitoring with alarm systems.
4.3 Document storage location in Sample Storage Log (Annexure-3).
5. Transport
5.1 Package samples per IATA regulations for biological substances.
5.2 Maintain cold chain integrity during transport.
5.3 Complete Chain of Custody Log (Annexure-4).
6. Documentation
6.1 Maintain Sample Documentation File containing collection forms, logs, and transport records.
6.2 Verify accuracy during monitoring visits.
7. Deviations and Non-Compliance
7.1 Record deviations (e.g., delayed processing, temperature excursions) in Sample Deviation Log (Annexure-5).
7.2 Investigate deviations and implement CAPA.
Abbreviations
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- CRA: Clinical Research Associate
- QA: Quality Assurance
- CRO: Contract Research Organization
- IATA: International Air Transport Association
- ISF: Investigator Site File
- CAPA: Corrective and Preventive Action
Documents
- Sample Collection Log (Annexure-1)
- Sample Processing Log (Annexure-2)
- Sample Storage Log (Annexure-3)
- Chain of Custody Log (Annexure-4)
- Sample Deviation Log (Annexure-5)
References
- ICH E6(R2/R3) – Biological Samples in Clinical Trials
- FDA – Biospecimen Management Guidance
- EMA – Human Biological Sample Handling
- CDSCO – Clinical Sample Collection Regulations
- WHO – Guidance on Biological Sample Management
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Sample Collection Log
| Subject ID | Sample Type | Volume | Date/Time | Collected By |
|---|---|---|---|---|
| SUBJ-101 | Blood | 10 mL | 12/09/2025 09:15 | Meena Sharma |
Annexure-2: Sample Processing Log
| Sample ID | Processing Step | Date/Time | Processed By |
|---|---|---|---|
| S-101 | Centrifuged 3000 RPM, 10 min | 12/09/2025 09:45 | Lab Tech |
Annexure-3: Sample Storage Log
| Sample ID | Storage Location | Temperature | Date Stored | By |
|---|---|---|---|---|
| S-101 | Freezer −80°C | −80°C | 12/09/2025 | Lab Tech |
Annexure-4: Chain of Custody Log
| Date | Sample ID | From | To | Transport Conditions | Signature |
|---|---|---|---|---|---|
| 13/09/2025 | S-101 | Lab Tech | Courier | Dry ice | Signed |
Annexure-5: Sample Deviation Log
| Date | Sample ID | Deviation | Action Taken | Responsible |
|---|---|---|---|---|
| 14/09/2025 | S-101 | Delayed processing (3 hrs) | Reported, CAPA initiated | Lab Tech |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Quality |
For more SOPs visit: Pharma SOP