Standard Operating Procedure for Chain of Custody for Clinical Samples in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/077/2025
Supersedes	SOP/BA-BE/077/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standardized process for maintaining an uninterrupted and verifiable chain of custody for biological samples collected during Bioavailability/Bioequivalence (BA/BE) studies from the point of collection to final analysis or disposal.

2. Scope

This SOP applies to all clinical and laboratory staff responsible for collecting, transporting, storing, transferring, and receiving clinical samples (blood, plasma, serum) during BA/BE studies.

3. Responsibilities

• Phlebotomist: Ensures initial documentation and transfer of samples post-collection.
• Lab Technician: Maintains sample receipt, processing, and transfer logs.
• CRC: Oversees end-to-end documentation and review.
• QA Officer: Periodically audits chain of custody records for completeness and accuracy.

4. Accountability

The Study Principal Investigator is accountable for ensuring chain of custody procedures are rigorously followed and adequately documented throughout the lifecycle of clinical samples.

5. Procedure

5.1 Sample Identification and Labeling

1. Label samples immediately after collection with:
   • Subject ID
   • Date and time of collection
   • Timepoint and period
2. Verify label accuracy with Annexure-1: Sample Receipt and Verification Log.

5.2 Initial Handover and Logging

1. Phlebotomist hands over collected samples to lab staff within 30 minutes of collection.
2. Document transfer in Annexure-2: Sample Handover Log including:
   • Date and time
   • Sample condition
   • Recipient signature

5.3 Sample Tracking During Processing

1. Maintain Annexure-3: Sample Processing Log for centrifugation and aliquoting activities.
2. Link processing batch numbers and freezer box IDs for traceability.

5.4 Freezer Storage Documentation

1. Enter sample location in Annexure-4: Freezer Storage Record, capturing:
   • Freezer ID
   • Rack and slot number
   • Date/time of storage

5.5 Inter-Laboratory Transfer (if applicable)

1. Use validated insulated containers and temperature logs for transfer to bioanalytical site.
2. Generate Annexure-5: Chain of Custody Transfer Form signed by sender and receiver.

5.6 Sample Disposal or Return

1. Post-analysis, document either sample return or destruction as per sponsor or regulatory directive.
2. Maintain Annexure-6: Sample Disposal or Return Record.

5.7 Review and Audit Trail

1. CRC or QA staff to review chain of custody records weekly during the study phase.
2. Any missing entry or discrepancy must be resolved and documented via CAPA.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• ID: Identification

7. Documents

1. Sample Receipt and Verification Log – Annexure-1
2. Sample Handover Log – Annexure-2
3. Sample Processing Log – Annexure-3
4. Freezer Storage Record – Annexure-4
5. Chain of Custody Transfer Form – Annexure-5
6. Sample Disposal or Return Record – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• US FDA Guidance for BA/BE Studies
• 21 CFR Part 58 – GLP Regulations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Receipt and Verification Log

Subject ID	Timepoint	Date/Time	Verified By	Remarks
VOL-077	2h	17/04/2025, 08:20	R. Pawar	Correct

Annexure-2: Sample Handover Log

Sample ID	Handover From	To	Time	Condition	Signatures
VOL077/P1/2h	Phlebotomy	Lab	08:25	Intact	Ravi / Nisha

Annexure-3: Sample Processing Log

Sample ID	Process	Time	Handled By	Remarks
VOL077/P1/2h	Centrifugation	08:30	Sunita Reddy	Done

Annexure-4: Freezer Storage Record

Sample Code	Freezer ID	Rack No.	Box No.	Logged By	Date/Time
VOL077/P1/2h/A1	FZ-03	R1	BX04	Ravi Nair	17/04/2025, 09:00

Annexure-5: Chain of Custody Transfer Form

Date	From	To	Samples	Condition	Sent By	Received By
18/04/2025	Clinic	Bio Lab	VOL077/A1–A4	Frozen	Sunita	Vikas

Annexure-6: Sample Disposal or Return Record

Date	Sample ID	Action	Reason	Authorized By	Remarks
20/04/2025	VOL077/A4	Disposed	Unused aliquot	QA Head	Documented

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial release	Regulatory requirement	QA Head
17/04/2025	2.0	Updated with inter-lab transfer and disposal logs	Audit compliance	QA Head