Standard Operating Procedure for Safety Reporting to Ethics Committees and Institutional Review Boards

Purpose

This SOP outlines the procedures for safety reporting to Ethics Committees and Institutional Review Boards (IRBs) in clinical trials and clinical studies. The goal is to ensure timely and accurate reporting of safety information to Ethics Committees and IRBs, in compliance with regulatory requirements and study protocols.

Scope

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

Responsibilities

• Principal Investigator (PI): Ensures the timely and accurate reporting of safety information to Ethics Committees and IRBs.
• Clinical Research Coordinators: Assist in gathering and documenting safety information and preparing reports for submission.
• Study Sponsors: Provide guidance and resources for safety reporting and compliance with regulations.

Procedure

• Safety Information Collection:
  • Collect safety information from various sources, including adverse event reports, safety data from external sources, and literature reviews.
• Assessment and Classification:
  • Assess safety information to determine its relevance and impact on study participants.
  • Classify safety information based on severity and seriousness, following regulatory definitions.
• Preparation of Safety Reports:
  • Prepare safety reports according to regulatory requirements and study protocols.
  • Include relevant information such as the nature of the safety issue, potential impact, and any corrective actions taken.
• Submission to Ethics Committees and IRBs:
  • Submit safety reports to the relevant Ethics Committees and IRBs within the specified timeframes.
  • Provide additional information or follow-up as requested by Ethics Committees and IRBs.
• Documentation and Record-Keeping:
  • Maintain records of safety reports, including submission dates, report content, and any correspondence with Ethics Committees and IRBs.
• Feedback and Continuous Improvement:
  • Gather feedback from Ethics Committees and IRBs on the safety reporting process and reports.
  • Use feedback to improve future safety reporting and enhance study quality and safety.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IRB: Institutional Review Board

Documents

• Safety reports
• Correspondence with Ethics Committees and IRBs
• Feedback from Ethics Committees and IRBs

References

• Regulatory guidelines for safety reporting to Ethics Committees and IRBs
• Institutional policies for safety reporting

SOP Version

Version: 1.0