Standard Operating Procedure for Managing Protocol Deviations and Violations

Purpose

This SOP outlines the procedures for identifying, documenting, and managing protocol deviations and violations in clinical trials and clinical studies. The goal is to ensure the integrity of the study and the safety of participants by promptly addressing and reporting deviations and violations.

Scope

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

Responsibilities

• Principal Investigator (PI): Oversees the management of protocol deviations and violations, ensuring appropriate reporting and corrective actions.
• Clinical Research Coordinators: Monitor study conduct to identify and report deviations and violations at the site level.
• Data Management Team: Assists with the documentation and reporting of deviations and violations in study data.
• Study Sponsors: Provide resources and support for the management of protocol deviations and violations.

Procedure

• Identification of Deviations and Violations:
  • Monitor study activities to identify protocol deviations and violations as they occur.
  • Review study data and documentation regularly to detect deviations and violations.
• Classification and Documentation:
  • Classify each incident as a deviation or violation based on the study protocol and guidelines.
  • Document each deviation or violation in a deviation log or record, including details such as the date, nature of the incident, and impact on the study.
• Reporting:
  • Report protocol deviations and violations to the appropriate parties (e.g., study sponsor, IRB/IEC) as required by regulatory guidelines and the study protocol.
  • Ensure timely reporting of serious violations that may impact participant safety or data integrity.
• Investigation and Root Cause Analysis:
  • Investigate each deviation or violation to determine the root cause and potential impact on the study.
  • Document the findings and proposed corrective actions.
• Corrective and Preventive Actions:
  • Implement corrective actions to address the immediate issue and prevent recurrence.
  • Review study procedures and training materials to minimize future deviations and violations.
• Follow-Up and Monitoring:
  • Monitor the effectiveness of corrective and preventive actions over time.
  • Conduct follow-up assessments to ensure compliance and identify any further areas for improvement.

Abbreviations Used

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

Documents

• Protocol deviation and violation logs
• Investigation and root cause analysis reports
• Corrective and preventive action plans
• Follow-up monitoring reports

References

• Institutional policies for handling protocol deviations and violations
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0