BA/BE clinical studies conducted at the research facility.

3. Responsibilities

• Clinical Research Coordinator (CRC): Coordinates labeling and documentation of samples for dispatch.
• Sample Handler/Technician: Ensures proper packaging, temperature monitoring, and handover to courier or internal transport team.
• Quality Assurance (QA): Reviews sample transport logs and ensures adherence to SOP.
• Transport Personnel: Ensures safe delivery and documentation of receipt at the bioanalytical lab.

4. Accountability

The Principal Investigator (PI) is accountable for ensuring that plasma samples are transported under validated conditions without compromising quality or traceability.

5. Procedure

5.1 Sample Preparation and Packaging

1. Ensure all plasma samples are properly aliquoted, labeled with:
   • Study ID
   • Subject ID
   • Timepoint
   • Visit date
2. Place labeled samples in cryoboxes and wrap with absorbent material.
3. Insert cryoboxes into validated cold chain transport containers pre-chilled to -20°C or as per protocol.
4. Include a temperature monitoring device (e.g., data logger or freeze tag).

5.2 Documentation

1. Prepare Annexure-1: Plasma Sample Dispatch Form containing:
   • Study code, sample IDs, timepoints, and box details
   • Transporter’s name and signature
2. Place a copy inside the transport container and retain one copy at site.

5.3 Transport Conditions

1. Ensure containers are validated for maintaining required temperature for the expected transport duration.
2. Mark the box with:
   • “Human Biological Samples – Handle with Care”
   • “Maintain Cold Chain”
3. Ensure transit time is minimized and direct delivery is preferred.

5.4 Receipt and Handover at Bioanalytical Lab

1. Upon arrival, the receiving lab staff verifies:
   • Seals and label integrity
   • Sample condition and quantity
   • Temperature log compliance
2. Receiving person signs Annexure-2: Sample Receipt Acknowledgment Form.

5.5 Deviations and Excursions

1. If temperature excursion or sample damage is observed:
   • Document incident in Annexure-3: Sample Transport Deviation Log
   • Inform QA and PI immediately

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• PI: Principal Investigator

7. Documents

1. Plasma Sample Dispatch Form – Annexure-1
2. Sample Receipt Acknowledgment Form – Annexure-2
3. Sample Transport Deviation Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO Guidance on Transport of Infectious Substances
• Study Protocol and Bioanalytical SOPs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Plasma Sample Dispatch Form

Study Code	Box ID	Sample IDs	Date	Sent By	Signature
BE/2025/094	BOX-01	VOL-101 to VOL-110	17/04/2025	Sunita Reddy	Signed

Annexure-2: Sample Receipt Acknowledgment Form

Date Received	Received By	Sample Condition	Seal Intact	Remarks
17/04/2025	Ajay Verma	Acceptable	Yes	Transport validated

Annexure-3: Sample Transport Deviation Log

Date	Box ID	Deviation	Action Taken	Notified To
17/04/2025	BOX-02	Temperature > -15°C	Samples quarantined	QA & PI

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	Study Start	QA Head
17/04/2025	2.0	Added deviation log and updated documentation forms	Audit Compliance	QA Head