Protocol for Monitoring Drug Safety in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and reporting adverse events, serious adverse events, and other safety-related information in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all study personnel involved in pharmacovigilance activities, including Investigators, Study Coordinators, Pharmacovigilance Officers, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for promptly reporting adverse events and serious adverse events to the sponsor and regulatory authorities, as required by study protocols and regulatory guidelines.
• The Study Coordinator is responsible for documenting adverse events, serious adverse events, and safety-related information in study documentation and communicating this information to relevant stakeholders.
• The Pharmacovigilance Officer is responsible for monitoring safety data, assessing the potential risks and benefits of study interventions, and implementing risk management strategies to ensure participant safety.
• The Clinical Research Associate (CRA) is responsible for monitoring pharmacovigilance activities, ensuring compliance with safety reporting requirements, and verifying the accuracy and completeness of safety data reported by study sites.

Procedure

1. Educate study personnel on the importance of pharmacovigilance, including the recognition, assessment, and reporting of adverse events and serious adverse events.
2. Establish procedures for the timely reporting of adverse events, serious adverse events, and safety-related information to the sponsor, Institutional Review Board (IRB), and regulatory authorities, in accordance with study protocols and regulatory requirements.
3. Implement a system for collecting, recording, and documenting safety data, including adverse event forms, electronic data capture systems, and other study documentation.
4. Monitor safety data throughout the study conduct, including regular review of adverse event reports, safety databases, and study logs, to identify trends, patterns, and potential safety signals.
5. Assess the severity, causality, and expectedness of reported adverse events and serious adverse events to determine their impact on participant safety and study conduct.
6. Implement risk management strategies, such as protocol amendments, participant discontinuations, or additional safety monitoring, to mitigate potential risks identified through safety data analysis.
7. Document all pharmacovigilance activities, including adverse event reporting, risk assessments, and risk management decisions, in study documentation, communication logs, and safety databases.
8. Communicate safety data findings, trends, and risk management strategies to relevant stakeholders, including Investigators, study personnel, sponsors, and regulatory authorities, as required.

Abbreviations

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

Documents

• Adverse Event Form
• Electronic Data Capture System
• Safety Database
• Communication Log

Reference

International Council for Harmonisation (ICH) E2A Clinical Safety Data Management guidelines and relevant regulatory guidelines for pharmacovigilance in clinical research.

SOP Version

Version 1.0