Protocol for Management of External Laboratory Data in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling and integration of external laboratory results into Bioavailability (BA) and Bioequivalence (BE) study databases, ensuring accuracy, consistency, and compliance with study protocols.

Scope

This SOP applies to all study personnel involved in the receipt, review, integration, and documentation of external laboratory results obtained from third-party testing facilities, including Investigators, Data Managers, and Clinical Research Associates (CRAs).

Responsibilities

• The Investigator is responsible for reviewing and verifying external laboratory results for accuracy, completeness, and relevance to study objectives, ensuring that all results are obtained from qualified and accredited testing facilities.
• The Data Manager is responsible for integrating external laboratory results into study databases, reconciling discrepancies, and ensuring that all data are properly documented, coded, and formatted for analysis and reporting.
• The Clinical Research Associate (CRA) is responsible for monitoring the submission, receipt, and documentation of external laboratory results at study sites, verifying compliance with study protocols and regulatory requirements.

Procedure

1. Educate study personnel about the importance of accurate and reliable external laboratory data in BA/BE studies, including the need for adherence to study protocols, regulatory requirements, and data quality standards.
2. Identify qualified and accredited external laboratories capable of performing required testing procedures in compliance with study protocols, regulatory requirements, and industry standards.
3. Establish procedures for the submission, receipt, and review of external laboratory results, including documentation requirements, data transfer protocols, and quality assurance measures.
4. Coordinate with external laboratories to ensure timely and accurate transmission of laboratory results to study sites, using secure data transfer methods and encryption technologies to protect data integrity and confidentiality.
5. Review external laboratory results upon receipt, verifying accuracy, completeness, and relevance to study objectives, and documenting any discrepancies or deviations for resolution with the laboratory and study sponsor.
6. Integrate external laboratory results into study databases promptly, ensuring that data are properly coded, formatted, and labeled for analysis, and reconciling any discrepancies or inconsistencies with source documents.
7. Validate integrated laboratory data against predefined validation checks, including range checks, logic checks, and data quality assessments, to ensure data accuracy, completeness, and consistency.
8. Document all activities related to the handling and integration of external laboratory results, including receipt logs, review records, data integration logs, and data validation reports, for audit trail purposes.
9. Implement corrective and preventive actions (CAPAs) to address any deficiencies or discrepancies identified during the handling or integration of external laboratory results, ensuring continuous improvement and adherence to best practices.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• CAPA – Corrective and Preventive Actions

Documents

• External Laboratory Results Submission Form
• Data Integration Log
• Data Validation Reports
• Communication Logs with External Laboratories

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for handling external laboratory data in clinical research.

SOP Version

Version 1.0