Protocol for Managing Conflict of Interest in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the identification, disclosure, and management of conflicts of interest among personnel involved in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all study personnel, including Investigators, Study Coordinators, Clinical Research Associates (CRAs), Data Managers, and Laboratory Technicians.

Responsibilities

• The Study Coordinator is responsible for ensuring that all study personnel are aware of the importance of disclosing potential conflicts of interest and facilitating the disclosure process.
• The Investigator is responsible for promptly disclosing any conflicts of interest that may arise during the course of the study and taking appropriate actions to manage or mitigate conflicts.
• The Clinical Research Associate (CRA) is responsible for monitoring study conduct and identifying any conflicts of interest that may impact study integrity or participant safety.
• The Data Manager is responsible for disclosing any conflicts of interest related to data management activities and ensuring that data integrity is maintained throughout the study.
• The Laboratory Technician is responsible for disclosing any conflicts of interest related to laboratory procedures or analysis and adhering to quality control measures to minimize bias.

Procedure

1. Educate study personnel on the importance of identifying and disclosing conflicts of interest that may arise during the course of the study.
2. Require study personnel to complete a conflict of interest disclosure form at the initiation of the study and periodically throughout the study as needed.
3. Review and assess disclosed conflicts of interest to determine their potential impact on study integrity, participant safety, and data validity.
4. Develop and implement strategies to manage or mitigate conflicts of interest, such as recusal from certain study activities, appointment of independent oversight committees, or external review of study data.
5. Document all disclosed conflicts of interest, assessments, and management strategies in a centralized conflict of interest register or database.
6. Communicate any identified conflicts of interest and management strategies to relevant stakeholders, including sponsors, Institutional Review Boards (IRBs), and regulatory authorities, as required.
7. Monitor ongoing compliance with conflict of interest disclosure requirements throughout the study conduct and take corrective actions as needed to address non-compliance.
8. Conduct periodic reviews of the conflict of interest disclosure process to identify areas for improvement and implement revisions as necessary to enhance transparency and accountability.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• IRB – Institutional Review Board

Documents

• Conflict of Interest Disclosure Form
• Conflict of Interest Register
• Communication Log
• Training Materials

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for managing conflicts of interest in clinical research.

SOP Version

Version 1.0