SOP for chain of custody logs – Clinical Research Made Simple

SOP for Chain of Identity & Chain of Custody (Cell/Gene)

digi — Thu, 02 Oct 2025 10:52:06 +0000

SOP for Chain of Identity & Chain of Custody (Cell/Gene)

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Standard Operating Procedure for Chain of Identity & Chain of Custody (Cell/Gene)

SOP No.	CR/OPS/111/2025
Supersedes	NA
Page No.	1 of 52
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Purpose

The purpose of this SOP is to define the processes required to maintain Chain of Identity (CoI) and Chain of Custody (CoC) for cell and gene therapy products used in clinical trials. These processes ensure traceability, product integrity, subject safety, and regulatory compliance from collection through administration and follow-up.

Scope

This SOP applies to sponsors, investigators, CROs, laboratories, GMP manufacturing facilities, couriers, and site staff involved in ATMP (Advanced Therapy Medicinal Product) clinical trials. It covers sample collection, labeling, custody transfers, product tracking, custody documentation, and archival of records.

Responsibilities

Sponsor: Oversees CoI/CoC processes and ensures regulatory compliance.
Investigator: Ensures subject-specific identity verification at site level.
GMP Facility: Maintains manufacturing custody records and certificates of analysis.
CRO: Monitors CoI/CoC compliance across sites and vendors.
Courier: Maintains custody during product transportation.
QA: Audits CoI/CoC logs for accuracy and completeness.

Accountability

The Sponsor’s ATMP Quality Lead is accountable for overall compliance with Chain of Identity and Chain of Custody procedures. The Investigator is accountable for subject-level verification prior to administration.

Procedure

1. Chain of Identity (CoI)
1.1 Assign unique subject-specific identifiers at time of collection.
1.2 Verify identifiers at each step: collection, processing, manufacturing, and administration.
1.3 Document in Chain of Identity Log (Annexure-1).

2. Chain of Custody (CoC)
2.1 Record all custody transfers from collection through manufacturing, shipment, storage, and administration.
2.2 Use controlled custody forms signed by transferring and receiving personnel.
2.3 Maintain records in Chain of Custody Log (Annexure-2).

3. Custody Transfer
3.1 At each transfer, verify subject identifier, product batch/lot number, and condition.
3.2 Document signatures, date, and time for both transferring and receiving parties.

4. Manufacturing and Quality Control
4.1 GMP facility verifies CoI before initiating processing.
4.2 Issue Certificate of Analysis linked to subject-specific identifiers.

5. Shipment and Storage
5.1 Use validated containers and cold-chain requirements.
5.2 Record shipment details in Custody Transfer Log (Annexure-3).

6. Administration at Site
6.1 Prior to administration, Investigator verifies subject identifier against CoI records.
6.2 Document in Site Administration Log (Annexure-4).

7. Archiving
7.1 Archive all CoI/CoC records in TMF and ISF.
7.2 Retain per global ATMP regulations (minimum 25 years in some regions).

Abbreviations

SOP: Standard Operating Procedure
CoI: Chain of Identity
CoC: Chain of Custody
ATMP: Advanced Therapy Medicinal Products
QA: Quality Assurance
CRO: Contract Research Organization
GMP: Good Manufacturing Practice
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

Chain of Identity Log (Annexure-1)
Chain of Custody Log (Annexure-2)
Custody Transfer Log (Annexure-3)
Site Administration Log (Annexure-4)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, ATMP Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: Chain of Identity Log

Date	Subject ID	Sample ID	Verified By	Status
01/09/2025	S101	S101-C1	Site Coordinator	Verified

Annexure-2: Chain of Custody Log

Date	Product ID	Transferred From	Transferred To	Signature
02/09/2025	S101-C1	Collection Site	Courier	Signed

Annexure-3: Custody Transfer Log

Date	Product ID	Location	Responsible	Condition
03/09/2025	S101-C1	Manufacturing Facility	Technician	Acceptable

Annexure-4: Site Administration Log

Date	Subject ID	Product ID	Verified By	Administered By
05/09/2025	S101	S101-C1	Investigator	Study Nurse

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

SOP for Sample Shipment and Chain of Custody

digi — Thu, 18 Sep 2025 10:48:19 +0000

SOP for Sample Shipment and Chain of Custody

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Standard Operating Procedure for Sample Shipment and Chain of Custody

SOP No.	CR/OPS/084/2025
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 procedures for the shipment of biological samples in clinical trials, ensuring integrity, confidentiality, and compliance with international guidelines such as ICH GCP, FDA, EMA, CDSCO, WHO, and IATA Dangerous Goods Regulations.

Scope

This SOP applies to all clinical trial personnel, including investigators, laboratory staff, couriers, and CROs involved in sample packaging, shipment, transport, and receipt. It covers temperature-controlled shipments, dry ice packaging, courier qualification, chain of custody documentation, and deviation handling.

Responsibilities

Investigator: Ensures compliance with protocol requirements for sample shipment.
Clinical Staff: Prepares, packages, and documents samples before shipment.
Courier: Transports samples under validated, compliant conditions.
Laboratory Staff: Verify receipt and integrity of samples upon arrival.
CRA: Reviews shipment documentation during monitoring visits.
QA: Audits shipment records and chain of custody compliance.

Accountability

The Sponsor is accountable for oversight of sample shipment procedures and vendor qualification. The Investigator is accountable for accurate pre-shipment documentation and chain of custody. QA is accountable for ensuring compliance with applicable regulations.

Procedure

1. Courier Qualification
1.1 Only couriers qualified and audited for biological sample handling may be used.
1.2 Maintain Vendor Qualification File with certificates and audits.

2. Packaging
2.1 Follow IATA Packing Instruction 650 for biological substances (Category B).
2.2 Use triple-layer packaging (primary container, secondary leak-proof container, outer package).
2.3 Label packages with “Biological Substance, Category B” and dry ice details (if applicable).

3. Pre-Shipment Documentation
3.1 Complete Sample Shipment Form (Annexure-1) for each shipment.
3.2 Document temperature monitoring devices inside packages.
3.3 Investigator or delegated staff signs Chain of Custody Log (Annexure-2).

4. Transport
4.1 Couriers must maintain specified temperature ranges (e.g., 2–8°C, −20°C, −80°C).
4.2 Couriers record each transfer point in the Chain of Custody Log.
4.3 Any delays or incidents must be documented in Shipment Deviation Log (Annexure-3).

5. Receipt of Samples
5.1 Laboratory staff verify integrity, labeling, and temperature conditions.
5.2 Document receipt in Sample Receipt Log (Annexure-4).
5.3 Notify Sponsor/Investigator immediately in case of discrepancies.

6. Chain of Custody
6.1 Maintain uninterrupted custody from collection site to laboratory.
6.2 All handovers must be signed, dated, and recorded.
6.3 QA verifies chain of custody completeness during audits.

7. Deviations
7.1 Record deviations (e.g., temperature excursion, courier delays) in Shipment Deviation Log.
7.2 Investigate deviations and initiate CAPA.