Standard Operating Procedure for Monitoring and Auditing in Clinical Research

Purpose

This SOP outlines the procedures for monitoring and auditing in clinical trials and clinical studies. The goal is to ensure study compliance with protocols, regulatory requirements, and good clinical practice (GCP) standards.

Scope

This SOP applies to all personnel involved in monitoring and auditing activities, including principal investigators, clinical research coordinators, monitors, auditors, and other study team members.

Responsibilities

• Principal Investigator (PI): Ensures compliance with the study protocol and facilitates monitoring and auditing activities.
• Clinical Research Coordinators: Assist in preparing for monitoring and auditing visits and implement corrective actions as needed.
• Monitors: Review study activities and data for compliance with the protocol and regulations.
• Auditors: Perform independent audits to assess compliance and identify areas for improvement.

Procedure

• Monitoring:
  • Conduct routine monitoring visits to assess study compliance with the protocol, GCP, and regulatory requirements.
  • Review study documents, including case report forms (CRFs), informed consent forms (ICFs), and source documentation.
  • Observe study procedures and verify that they are being conducted as per the protocol.
  • Document monitoring findings and communicate any issues to the study team.
  • Recommend corrective actions and follow up on their implementation.
• Auditing:
  • Plan and conduct independent audits to assess study compliance with regulatory and institutional standards.
  • Review study records, including regulatory documents, logs, and reports.
  • Assess data integrity and quality, including data collection and management processes.
  • Identify areas of non-compliance and recommend corrective actions.
  • Document audit findings and report them to the study team and sponsor.
• Follow-Up and Corrective Actions:
  • Work with the study team to address monitoring and audit findings.
  • Implement corrective actions to resolve identified issues.
  • Conduct follow-up visits or audits to verify that corrective actions have been implemented effectively.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• GCP: Good Clinical Practice
• CRF: Case Report Form
• ICF: Informed Consent Form

Documents

• Monitoring and audit plans
• Monitoring visit reports
• Audit reports
• Corrective action plans

References

• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Institutional policies and procedures

SOP Version

Version: 1.0