Protocol for Monitoring Study Progress and Data Quality in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to define procedures for conducting interim analysis and monitoring data quality during the course of Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all study personnel involved in data collection, management, and analysis, including Investigators, Statisticians, Study Coordinators, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for overseeing data collection, ensuring data integrity, and conducting interim analysis to assess study progress and safety.
• The Statistician is responsible for performing statistical analysis, including interim analysis, to evaluate study outcomes, efficacy, and safety parameters.
• The Study Coordinator is responsible for coordinating data collection, monitoring data quality, and facilitating data transfer to the Statistician for analysis.
• The Clinical Research Associate (CRA) is responsible for monitoring study conduct, ensuring compliance with study protocols, and verifying the accuracy and completeness of study data.

Procedure

1. Establish a Data Monitoring Committee (DMC) or Independent Data Monitoring Board (IDMB) to oversee interim analysis and data monitoring activities, if required by study protocols or regulatory guidelines.
2. Define the parameters and endpoints for interim analysis, including efficacy, safety, and futility criteria, in consultation with the study team and relevant stakeholders.
3. Conduct interim analysis at predefined intervals or upon reaching specified milestones during the study conduct, using appropriate statistical methods and techniques.
4. Review interim analysis results to assess study progress, evaluate safety outcomes, and make informed decisions regarding study continuation, modification, or termination.
5. Communicate interim analysis findings and recommendations to the Data Monitoring Committee (DMC), study team, Investigators, and regulatory authorities, as necessary.
6. Monitor data quality throughout the study conduct, including regular review of case report forms (CRFs), electronic data capture (EDC) systems, and study databases.
7. Implement data validation checks, query resolution processes, and corrective actions to address data discrepancies, errors, or missing values identified during data monitoring.
8. Ensure compliance with Good Clinical Practice (GCP) guidelines, study protocols, and regulatory requirements for data collection, management, and analysis throughout the study conduct.
9. Maintain accurate and complete documentation of interim analysis results, data monitoring activities, and any modifications to study protocols or procedures resulting from data analysis.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• DMC – Data Monitoring Committee
• IDMB – Independent Data Monitoring Board
• CRA – Clinical Research Associate
• CRF – Case Report Form
• EDC – Electronic Data Capture
• GCP – Good Clinical Practice

Documents

• Interim Analysis Plan
• Data Monitoring Plan
• Communication Log
• Study Protocol

Reference

International Council for Harmonisation (ICH) E9 Statistical Principles for Clinical Trials guidelines and relevant regulatory guidelines for conducting interim analysis and data monitoring in clinical research.

SOP Version

Version 1.0