Protocol for Standardizing Endpoint Assessment in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for endpoint adjudication in Bioavailability (BA) and Bioequivalence (BE) studies to ensure consistency and accuracy in the assessment of study endpoints.

Scope

This SOP applies to all study personnel involved in the adjudication of study endpoints, including Investigators, Endpoint Adjudication Committee (EAC) members, Study Coordinators, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for identifying and documenting study endpoints, ensuring their relevance to study objectives, and providing necessary information to the Endpoint Adjudication Committee (EAC).
• The Endpoint Adjudication Committee (EAC) is responsible for independently reviewing and adjudicating study endpoints based on predefined criteria and standardized assessment procedures.
• The Study Coordinator is responsible for facilitating communication between the Investigator and the Endpoint Adjudication Committee (EAC), coordinating endpoint adjudication activities, and maintaining endpoint adjudication records.
• The Clinical Research Associate (CRA) is responsible for monitoring endpoint adjudication processes, ensuring compliance with study protocols and regulatory requirements, and verifying the accuracy and completeness of endpoint adjudication documentation.

Procedure

1. Establish an Endpoint Adjudication Committee (EAC) comprising qualified experts with relevant clinical and scientific expertise to review and adjudicate study endpoints.
2. Define the criteria and definitions for each study endpoint in the study protocol or endpoint adjudication charter, including objective measures, assessment methods, and adjudication outcomes.
3. Conduct training sessions for EAC members to ensure understanding of endpoint adjudication criteria, assessment procedures, and consistency in endpoint evaluation.
4. Provide EAC members with access to relevant study documentation, including case report forms (CRFs), medical records, laboratory results, and imaging studies, for endpoint adjudication.
5. Independently review and adjudicate study endpoints based on predefined criteria and standardized assessment procedures, ensuring consistency and accuracy in endpoint assessment.
6. Document endpoint adjudication decisions, including rationale for adjudication outcomes, in endpoint adjudication forms, committee meeting minutes, and study documentation.
7. Resolve any discrepancies or disagreements in endpoint adjudication through consensus discussions among EAC members or consultation with the Investigator and study team, as needed.
8. Communicate endpoint adjudication decisions to the Investigator, study team, and relevant stakeholders in a timely manner, ensuring transparency and clarity in reporting endpoint outcomes.
9. Monitor endpoint adjudication processes throughout the study conduct, including regular review of endpoint adjudication documentation, to ensure adherence to predefined criteria and compliance with regulatory requirements.
10. Document all endpoint adjudication activities, decisions, and communications in study documentation, endpoint adjudication records, and communication logs for audit trail purposes.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• EAC – Endpoint Adjudication Committee
• CRA – Clinical Research Associate
• CRF – Case Report Form

Documents

• Endpoint Adjudication Charter
• Endpoint Adjudication Forms
• Communication Log
• Study Protocol

Reference

International Council for Harmonisation (ICH) E9 Statistical Principles for Clinical Trials guidelines and relevant regulatory guidelines for endpoint adjudication in clinical research.

SOP Version

Version 1.0