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Standard Operating Procedure for Access Control and User Authorization (Paper/Electronic)

Purpose

The purpose of this SOP is to establish secure processes for managing access control and user authorization in both paper-based and electronic clinical trial systems. Proper access control ensures data confidentiality, integrity, and accountability, protecting trial data from unauthorized access or alteration.

Scope

This SOP applies to all clinical trial stakeholders including investigators, study coordinators, CRAs, data managers, CROs, and sponsors. It covers paper record access, electronic system authorization, password management, periodic access reviews, and access revocation.

Responsibilities

• Principal Investigator (PI): Authorizes site staff access to trial-related records and systems.
• Study Coordinator: Manages site-level access logs and ensures compliance with access policies.
• Data Manager: Manages user accounts in electronic data capture (EDC) and clinical databases.
• Sponsor/CRO: Ensures secure access control policies are implemented and periodically reviewed.
• QA Officer: Audits access logs and verifies compliance with access control SOPs.

Accountability

The PI is accountable for authorizing access at site level, while the sponsor is accountable for global oversight and system-level access compliance.

Procedure

1. Paper Record Access Control
Store trial documents (ISF, CRFs, source documents) in locked cabinets with restricted key access.
Maintain a Paper Access Log (Annexure-1) recording date, name, purpose, and authorization of access.

2. Electronic System Access
Access to EDC, CDMS, and safety databases must be role-based.
Provide unique user IDs and enforce strong password policies.
Maintain audit trails for all login, modification, and logout activities.

3. User Authorization
PI or sponsor must approve user account creation.
Document authorization in User Authorization Log (Annexure-2).
Assign roles based on job responsibilities (e.g., data entry, monitor, PI, sponsor).

4. Access Reviews
Conduct quarterly access reviews to ensure active users are current trial staff.
Immediately revoke access for staff leaving the study.

5. Access Revocation
Inactive or unauthorized accounts must be disabled immediately.
Record revocation details in Access Revocation Log (Annexure-3).

6. Archiving
Archive access logs and authorization records in ISF/TMF.
Retain access control documentation for a minimum of 15 years.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRA: Clinical Research Associate
• CRO: Clinical Research Organization
• QA: Quality Assurance
• ISF: Investigator Site File
• TMF: Trial Master File
• EDC: Electronic Data Capture
• CDMS: Clinical Data Management System

Documents

1. Paper Access Log (Annexure-1)
2. User Authorization Log (Annexure-2)
3. Access Revocation Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Guidance on Computerized Systems in Clinical Trials
• EMA – Access Control and Computerized Systems
• CDSCO – Clinical Trial Data Security Guidelines
• WHO – Data Protection and Security in Clinical Research

Version: 1.0

Approval Section

Annexures

Annexure-1: Paper Access Log

Annexure-2: User Authorization Log

Annexure-3: Access Revocation Log

Revision History

For more SOPs visit: Pharma SOP