Protocol for Reassessment of Analytical Results in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the reanalysis of samples in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring accuracy, reliability, and integrity of analytical results.

Scope

This SOP applies to all study personnel involved in the reanalysis of samples obtained from bioavailability or bioequivalence studies, including Laboratory Analysts, Data Managers, and Quality Assurance Personnel.

Responsibilities

• The Laboratory Analyst is responsible for performing sample reanalysis according to predefined procedures, ensuring adherence to analytical methods and quality control measures.
• The Data Manager is responsible for reviewing reanalyzed data, comparing results with initial findings, and documenting any discrepancies or deviations for further investigation.
• The Quality Assurance Personnel is responsible for overseeing the sample reanalysis process, reviewing and approving reanalysis protocols, and ensuring compliance with regulatory requirements and quality standards.

Procedure

1. Establish criteria for sample reanalysis, including triggers for reanalysis, such as data outliers, instrument malfunction, or quality control failures, and define the scope and objectives of reanalysis.
2. Document the reasons for sample reanalysis, including any discrepancies or deviations observed during initial analysis, and obtain approval from the designated authority or study sponsor to proceed with reanalysis.
3. Retrieve samples from storage and prepare them for reanalysis, ensuring proper sample handling, labeling, and storage conditions to prevent degradation or contamination.
4. Perform sample reanalysis according to predefined analytical methods and procedures, using the same or equivalent instruments, reagents, and analytical conditions as the initial analysis.
5. Document all reanalysis activities, including sample preparation, instrument parameters, analytical procedures, and any deviations or observations encountered during reanalysis, in a reanalysis log or report.
6. Compare reanalyzed results with initial findings, assessing consistency, accuracy, and precision of analytical results, and document any discrepancies or deviations for further investigation and resolution.
7. Conduct root cause analysis to identify the reasons for discrepancies between initial and reanalyzed results, considering factors such as sample integrity, analytical methods, instrument performance, and operator error.
8. Implement corrective actions and process improvements based on root cause analysis findings, addressing any deficiencies or issues identified in the sample reanalysis process, to prevent recurrence and ensure data integrity.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence

Documents

• Sample Reanalysis Protocol
• Reanalysis Log or Report
• Root Cause Analysis Report
• Corrective Action Reports

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for sample reanalysis procedures in clinical research.

SOP Version

Version 1.0