Standard Operating Procedure for SAE Reporting

Purpose

This SOP outlines the procedures for identifying, documenting, and reporting serious adverse events (SAEs) in clinical trials and clinical studies. The goal is to ensure participant safety, data integrity, and regulatory compliance by promptly reporting SAEs and taking appropriate actions.

Scope

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

Responsibilities

• Principal Investigator (PI): Oversees SAE reporting and ensures compliance with regulatory requirements.
• Clinical Research Coordinators: Identify and document SAEs, and report them according to study protocol and regulations.
• Data Management Team: Manages SAE data and assists with documentation and reporting.
• Study Sponsors: Provide resources and support for SAE reporting and management.

Procedure

• Identification of SAEs:
  • Monitor study activities and participant health to identify SAEs as they occur.
  • Collect and review data from participant assessments, medical records, and reports from study staff.
• Documentation:
  • Document each SAE in detail, including the date, nature, severity, and outcome of the event.
  • Record information about the affected participant, such as demographic data and medical history.
• Assessment and Follow-Up:
  • Assess the SAE to determine its relationship to the study intervention and its impact on the participant.
  • Conduct follow-up assessments and monitoring to track the participant’s condition and response to any interventions.
• Reporting:
  • Report SAEs to the appropriate parties (e.g., study sponsor, IRB/IEC, regulatory authorities) as required by regulatory guidelines and the study protocol.
  • Ensure timely reporting of SAEs to maintain compliance with regulatory requirements.
• Corrective and Preventive Actions:
  • Implement corrective actions as needed to address the SAE and prevent recurrence.
  • Document actions taken and communicate them to relevant stakeholders.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SAE: Serious Adverse Event
• IRB/IEC: Institutional Review Board/Independent Ethics Committee

Documents

• SAE logs and records
• Assessment and follow-up reports
• SAE reporting forms

References

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

SOP Version

Version: 1.0