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Standard Operating Procedure for Subject ID Assignment and Tracking

Purpose

The purpose of this SOP is to establish a standardized process for assigning unique subject identification (ID) numbers and maintaining tracking logs in clinical trials. This ensures participant confidentiality, data integrity, and traceability throughout the study.

Scope

This SOP applies to Principal Investigators, study coordinators, data managers, and site staff responsible for subject identification, enrollment, and tracking in clinical trials. It covers both manual and electronic systems for subject ID assignment and tracking.

Responsibilities

• Principal Investigator (PI): Oversees subject ID assignment and confirms compliance with protocol and regulatory requirements.
• Study Coordinator: Assigns IDs sequentially and maintains Subject ID Log.
• Data Manager: Ensures subject IDs are consistent across CRFs, databases, and monitoring reports.
• Sponsor/CRO: Verifies subject ID assignment during monitoring visits.
• Quality Assurance Officer: Audits subject ID tracking logs for accuracy and compliance.

Accountability

The PI is accountable for ensuring that subject IDs are unique, confidential, and properly documented. Sponsors are accountable for oversight of ID assignment across multi-site trials.

Procedure

1. Subject ID Assignment
Assign subject IDs sequentially starting from screening.
Format IDs with site code, trial code, and sequential number (e.g., CT2025-SITE01-001).
Ensure IDs are unique across all participants.

2. Subject ID Log Maintenance
Maintain Subject ID Log (Annexure-1) recording assigned numbers, subject initials, and enrollment status.
Ensure log is signed and dated by authorized staff.

3. Confidentiality
Do not include personal identifiers (name, address) in ID logs.
Maintain linkage file separately in a secured location accessible only to PI.

4. Use in Documentation
Use assigned subject IDs in all case report forms (CRFs), databases, and communications.
Verify consistency across all trial documentation.

5. Withdrawal and Re-Screening
Document withdrawn subjects with reasons in Withdrawal Log.
Assign a new ID for re-screened participants; do not reuse IDs.

6. Monitoring and Auditing
Monitors verify subject ID assignment during site visits.
QA audits include review of logs, CRFs, and ID allocation procedures.

7. Archiving
Archive Subject ID Logs and related documents in ISF and TMF.
Retain records for minimum 5 years post-trial or as per local laws.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• CRF: Case Report Form
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. Subject ID Log (Annexure-1)
2. Subject Withdrawal Log (Annexure-2)
3. Re-Screening Record (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trials Guidance
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Clinical Trial Ethics and Oversight

Version: 1.0

Approval Section

Annexures

Annexure-1: Subject ID Log

Annexure-2: Subject Withdrawal Log

Annexure-3: Re-Screening Record

Revision History

For more SOPs visit: Pharma SOP