Standard Operating Procedure for Drug Safety Monitoring

Purpose

This SOP outlines the procedures for pharmacovigilance and drug safety monitoring in clinical trials and clinical studies. The goal is to ensure the safety of participants by identifying, assessing, and managing any adverse events or drug-related risks throughout the study.

Scope

This SOP applies to all personnel involved in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, data management teams, and other study staff.

Responsibilities

• Principal Investigator (PI): Oversees pharmacovigilance activities, ensuring compliance with study protocols and regulatory requirements.
• Clinical Research Coordinators: Monitor and report adverse events and safety concerns at the study site level.
• Data Management Team: Collects and manages safety data, ensuring data integrity and accuracy.
• Drug Safety Team: Assesses adverse events, safety signals, and trends, and communicates with regulatory authorities as necessary.

Procedure

• Adverse Event (AE) Identification and Reporting:
  • Identify and record all adverse events reported by study participants or observed during study visits.
  • Report serious adverse events (SAEs) to the sponsor and regulatory authorities within the required timelines.
• Safety Data Collection and Management:
  • Collect and maintain accurate and complete safety data, including adverse event reports and lab results.
  • Ensure safety data is stored securely and access is restricted to authorized personnel.
• Signal Detection and Assessment:
  • Monitor safety data to detect potential safety signals or trends.
  • Assess and investigate safety signals to determine potential risks to participants.
• Risk Management and Mitigation:
  • Implement risk management plans and mitigation strategies for identified safety concerns.
  • Provide safety-related recommendations to the study team and sponsors as needed.
• Communication and Reporting:
  • Communicate safety findings and updates to study team members, sponsors, and regulatory authorities.
  • Prepare and submit safety reports as required by regulatory agencies.
• Training and Education:
  • Provide training to study personnel on pharmacovigilance processes and procedures.
  • Offer ongoing education to ensure compliance with safety monitoring requirements.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• AE: Adverse Event
• SAE: Serious Adverse Event

Documents

• Adverse event reports and logs
• Safety data and monitoring logs
• Risk management plans and strategies
• Safety reports submitted to regulatory authorities
• Training and education materials for safety monitoring

References

• Institutional policies for pharmacovigilance and drug safety
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0