Protocol for Surveillance and Documentation of Adverse Events in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic monitoring, documentation, assessment, and reporting of adverse events (AEs) occurring during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the conduct and oversight of BA/BE studies, including Study Coordinators, Clinical Research Associates (CRAs), Principal Investigators, and Safety Monitors.

Responsibilities

• The Study Coordinator is responsible for monitoring adverse events, documenting occurrences, and reporting them to the appropriate authorities in a timely manner.
• The Clinical Research Associate (CRA) is responsible for conducting regular site visits to assess participant safety, review adverse event documentation, and ensure compliance with reporting requirements.
• The Principal Investigator is responsible for assessing the severity and causality of adverse events, implementing appropriate actions to ensure participant safety, and reporting serious adverse events (SAEs) to regulatory authorities and sponsors.
• The Safety Monitor is responsible for reviewing adverse event reports, assessing trends, and providing recommendations for mitigating risks and improving participant safety.

Procedure

1. Educate study personnel on the definition of adverse events, reporting requirements, and procedures for documenting and reporting adverse events.
2. Implement a system for monitoring and documenting adverse events, including a standardized adverse event report form and process for escalation and review.
3. Train study personnel on adverse event assessment criteria, including severity, causality, and expectedness, to ensure consistent reporting and evaluation.
4. Monitor study participants for adverse events during study visits, procedures, and follow-up assessments, and document all observed or reported events promptly and accurately.
5. Assess the severity and relationship of adverse events to study interventions or procedures, using standardized criteria and clinical judgment.
6. Report adverse events to the appropriate authorities, including sponsors, regulatory agencies, institutional review boards (IRBs), and ethics committees, according to regulatory requirements and study protocols.
7. Document all adverse event reports, including the date of occurrence, description of the event, severity, outcome, and actions taken, in the study records and adverse event log.
8. Review adverse event reports regularly to identify trends, patterns, or potential safety signals, and take appropriate actions to mitigate risks and ensure participant safety.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• AE – Adverse Event
• CRA – Clinical Research Associate
• SAE – Serious Adverse Event
• IRB – Institutional Review Board

Documents

• Adverse Event Report Form
• Adverse Event Log
• Protocol Deviation Log (if applicable)
• Communication Log

Reference

International Conference on Harmonisation (ICH) E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting and relevant regulatory requirements for adverse event monitoring and reporting in clinical research.

SOP Version

Version 1.0