Standard Operating Procedure for Identifying and Managing Conflicts of Interest in Clinical Research

Purpose

This SOP outlines the procedures for identifying, assessing, and managing conflicts of interest (COI) in clinical trials and clinical studies. The goal is to ensure the integrity of research and protect participants by preventing or mitigating conflicts of interest.

Scope

This SOP applies to all personnel involved in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study team members, and other relevant personnel.

Responsibilities

• Principal Investigator (PI): Discloses and manages potential conflicts of interest and ensures compliance with COI policies.
• Study Team Members: Disclose any potential conflicts of interest and adhere to COI management plans.
• Institutional Review Board (IRB): Reviews COI disclosures and management plans to ensure research integrity and participant protection.
• Research Administration: Provides guidance and oversight for COI disclosures and management plans and maintains records of COI declarations and resolutions.

Procedure

• Identification of Conflicts of Interest:
  • Require all study personnel, including the PI, to disclose any financial or non-financial interests that could influence their involvement in the study.
  • Encourage disclosure of relationships with sponsors, vendors, or other entities that may present a conflict of interest.
  • Establish regular intervals for COI disclosures throughout the study period.
• Assessment and Management of Conflicts of Interest:
  • Review COI disclosures to assess the potential impact on study integrity and participant safety.
  • Develop and implement a COI management plan if potential conflicts are identified, which may include removing personnel from certain study activities or assigning oversight responsibilities.
• Documentation and Reporting:
  • Document COI disclosures, assessments, and management plans for each study.
  • Report COI management plans to the IRB or other oversight bodies as required for review and approval.
  • Maintain records of COI management for auditing and compliance purposes.
• Training and Education:
  • Provide training to study personnel on COI policies, including disclosure requirements and management strategies.
  • Offer ongoing education to ensure study personnel stay informed about COI regulations and best practices.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• COI: Conflict of Interest
• IRB: Institutional Review Board

Documents

• COI disclosure forms
• COI management plans
• IRB reports and approvals
• Training and education materials

References

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

SOP Version

Version: 1.0