Standard Operating Procedure for Monitoring and Reporting Safety in Clinical Research

Purpose

This SOP outlines the procedures for safety monitoring and reporting in clinical trials and clinical studies. The aim is to ensure participant safety, promptly identify and manage adverse events, and comply with regulatory reporting requirements.

Scope

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

Responsibilities

• Principal Investigator (PI): Oversees safety monitoring and reporting, ensuring compliance with study protocols and regulatory requirements.
• Clinical Research Coordinators: Monitor participants for adverse events and report findings as required.
• Safety Monitors: Conduct safety assessments and report findings to the study team and regulatory authorities.

Procedure

• Safety Monitoring:
  • Monitor participants for adverse events during study visits and follow-up contacts.
  • Document all adverse events, regardless of severity, in the participant’s study records.
  • Assess the relationship between adverse events and study interventions.
• Adverse Event Reporting:
  • Report serious adverse events (SAEs) to regulatory authorities within the required timeframe.
  • Follow the study protocol for reporting non-serious adverse events.
  • Notify the ethics committee and sponsor of any significant safety concerns.
• Data Safety Monitoring Board (DSMB):
  • If applicable, coordinate with the DSMB to review safety data and make recommendations for study continuation or modification.
• Follow-Up and Documentation:
  • Conduct follow-up assessments of adverse events until resolution or stabilization.
  • Document all safety monitoring and reporting activities, including follow-up actions taken.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SAE: Serious Adverse Event
• DSMB: Data Safety Monitoring Board

Documents

• Adverse event logs and forms
• Safety monitoring reports
• DSMB reports (if applicable)
• Regulatory and ethics committee reports

References

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

SOP Version

Version: 1.0