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“headline”: “SOP for IVD Trial Sample Handling and Reporting”,
“description”: “This SOP defines standardized procedures for handling and reporting samples in in vitro diagnostic (IVD) clinical trials, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements. It covers collection, processing, shipment, chain of custody, result reporting, and quality oversight.”,
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Published on 22/12/2025
Standard Operating Procedure for IVD Trial Sample Handling and Reporting
| SOP No. | CR/OPS/109/2025 |
| Supersedes | NA |
| Page No. | 1 of 47 |
| 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 procedures for handling and reporting samples in in
Scope
This SOP applies to all sponsors, CROs, investigators, laboratories, and site staff involved in IVD clinical trials. It covers sample collection, labeling, processing, storage, shipment, chain of custody, laboratory testing, result reporting, and archiving of records.
Responsibilities
- Sponsor: Oversees IVD trial sample handling and ensures compliance with global regulations.
- Investigator/Site Staff: Responsible for accurate sample collection, labeling, and shipment.
- Laboratories: Perform sample analysis and maintain reporting accuracy.
- CRO: Monitors compliance with sample handling SOPs across sites.
- QA: Audits sample handling and reporting processes for accuracy and GCP compliance.
Accountability
The Investigator is accountable for site-level IVD sample handling and reporting. The Sponsor is accountable for ensuring oversight, data quality, and regulatory submission compliance.
Procedure
1. Sample Collection
1.1 Collect samples per study protocol and informed consent requirements.
1.2 Label each sample with subject ID, date, time, and trial identifier.
1.3 Record in Sample Collection Log (Annexure-1).
2. Sample Processing
2.1 Process samples as per laboratory manual (centrifugation, aliquoting, stabilization).
2.2 Document processing steps in Sample Processing Log (Annexure-2).
3. Sample Storage
3.1 Store samples under specified conditions (temperature, humidity, light protection).
3.2 Maintain storage records in Sample Storage Log (Annexure-3).
4. Sample Shipment
4.1 Ship samples using validated containers and cold-chain management.
4.2 Document shipment details in Sample Shipment Log (Annexure-4).
5. Chain of Custody
5.1 Maintain custody records from collection through analysis.
5.2 Ensure only authorized personnel handle samples.
5.3 Record in Chain of Custody Log (Annexure-5).
6. Result Reporting
6.1 Laboratories generate validated results and transmit securely to sponsor.
6.2 Record results in Result Reporting Log (Annexure-6).
6.3 Address discrepancies in reporting promptly.
7. Archiving
7.1 Archive sample records, logs, and test results in TMF and ISF.
7.2 Retain records per regulatory requirements.
Abbreviations
- SOP: Standard Operating Procedure
- IVD: In Vitro Diagnostic
- QA: Quality Assurance
- CRO: Contract Research Organization
- TMF: Trial Master File
- ISF: Investigator Site File
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
- CDSCO: Central Drugs Standard Control Organization
- WHO: World Health Organization
Documents
- Sample Collection Log (Annexure-1)
- Sample Processing Log (Annexure-2)
- Sample Storage Log (Annexure-3)
- Sample Shipment Log (Annexure-4)
- Chain of Custody Log (Annexure-5)
- Result Reporting Log (Annexure-6)
References
- FDA – In Vitro Diagnostics Guidance
- EMA – IVD Regulation (IVDR)
- CDSCO – IVD Clinical Performance Evaluation
- ICH GCP – Sample Handling Standards
- WHO – Best Practices for IVD Trials
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Laboratory Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Sample Collection Log
| Date | Subject ID | Sample Type | Collected By | Status |
|---|---|---|---|---|
| 01/09/2025 | S101 | Blood | Study Nurse | Collected |
Annexure-2: Sample Processing Log
| Date | Sample ID | Processing Activity | Performed By | Status |
|---|---|---|---|---|
| 01/09/2025 | S101-B1 | Centrifuged | Lab Technician | Completed |
Annexure-3: Sample Storage Log
| Date | Sample ID | Storage Temp | Stored By | Remarks |
|---|---|---|---|---|
| 02/09/2025 | S101-B1 | -20°C | Lab Assistant | Stable |
Annexure-4: Sample Shipment Log
| Date | Sample ID | Shipment Method | Shipped By | Status |
|---|---|---|---|---|
| 03/09/2025 | S101-B1 | Cold Chain Courier | Site Coordinator | In Transit |
Annexure-5: Chain of Custody Log
| Date | Sample ID | Transferred From | Transferred To | Signature |
|---|---|---|---|---|
| 03/09/2025 | S101-B1 | Site Coordinator | Courier | Signed |
Annexure-6: Result Reporting Log
| Date | Sample ID | Reported By | Result | Status |
|---|---|---|---|---|
| 05/09/2025 | S101-B1 | Lab Analyst | Negative | Reported |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP