Standard Operating Procedure for Quality Risk Assessment and Mitigation

Purpose

This SOP outlines the procedures for quality risk management in clinical trials and clinical studies. The goal is to proactively identify, assess, and mitigate risks that may impact the quality and integrity of a study, ensuring compliance with regulatory standards and protocols.

Scope

This SOP applies to all personnel involved in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, and quality assurance specialists.

Responsibilities

• Principal Investigator (PI): Oversees and supports quality risk management activities and ensures study quality and compliance.
• Quality Assurance Specialists: Lead risk assessments, implement risk management plans, and monitor risk mitigation efforts.
• Study Sponsors: Provide support and resources for quality risk management.
• Study Personnel: Participate in risk assessments and comply with risk mitigation measures.

Procedure

• Risk Identification:
  • Identify potential risks that may impact study quality, safety, and compliance through brainstorming sessions, historical data review, and expert consultations.
• Risk Assessment:
  • Assess the likelihood and impact of identified risks using a standardized risk assessment tool.
  • Prioritize risks based on their potential to affect study quality and participant safety.
• Risk Mitigation Planning:
  • Develop risk mitigation plans for prioritized risks, outlining strategies and measures to reduce risk likelihood or impact.
  • Assign responsibility for implementing risk mitigation measures to appropriate study personnel.
• Risk Monitoring:
  • Monitor risks throughout the study duration, paying close attention to any changes in risk factors.
  • Regularly review risk mitigation measures and make adjustments as needed.
• Documentation:
  • Maintain records of risk assessments, risk mitigation plans, and risk monitoring activities.
• Communication:
  • Communicate identified risks, risk assessment findings, and risk mitigation plans to relevant study personnel and stakeholders.
  • Report significant risks and mitigation measures to regulatory authorities as required.
• Continuous Improvement:
  • Regularly review and update risk management processes based on feedback and study outcomes.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• QA: Quality Assurance
• QRM: Quality Risk Management

Documents

• Risk identification and assessment tools
• Risk mitigation plans
• Risk monitoring and review records
• Risk communication records

References

• ICH-GCP guidelines for quality risk management
• Institutional policies for quality risk management

SOP Version

Version: 1.0