Protocol for Generating Final Study Reports in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures and responsibilities for preparing comprehensive final reports for Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the generation, review, and approval of final study reports, including Study Coordinators, Data Managers, Statisticians, and Principal Investigators.

Responsibilities

• The Study Coordinator is responsible for compiling study data, coordinating report preparation activities, and ensuring that report timelines are met.
• The Data Manager is responsible for verifying the accuracy and completeness of study data, conducting data analysis, and preparing data summaries for inclusion in the final report.
• The Statistician is responsible for performing statistical analyses, interpreting study results, and providing statistical input for the final report.
• The Principal Investigator is responsible for reviewing and approving the final report, ensuring that study findings are accurately presented and conclusions are supported by the data.

Procedure

1. Compile all study data, including raw data, case report forms (CRFs), laboratory reports, and pharmacokinetic data, into a comprehensive dataset for analysis.
2. Verify the accuracy and completeness of study data, conducting data cleaning and resolving any discrepancies or missing data points.
3. Perform statistical analysis of study data using appropriate statistical methods and software, generating summary tables, figures, and listings (TFLs) to summarize study findings.
4. Interpret study results in the context of study objectives, methodology, and statistical analysis, providing scientific rationale for study conclusions and recommendations.
5. Prepare a draft final report incorporating study background, objectives, methodology, results, discussion, and conclusions, following the format and template provided by the sponsor or regulatory guidelines.
6. Review the draft final report for accuracy, clarity, and compliance with regulatory requirements, incorporating feedback and revisions as necessary.
7. Obtain approval from the Principal Investigator and other relevant stakeholders, ensuring that all comments and revisions are addressed before finalizing the report.
8. Distribute the final report to the sponsor, regulatory authorities, and other stakeholders as required, ensuring that all necessary approvals and signatures are obtained.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRF – Case Report Form
• TFLs – Tables, Figures, and Listings

Documents

• Final Study Report
• Data Analysis Plan
• Statistical Analysis Plan
• Approval Forms

Reference

International Council for Harmonisation (ICH) E3 Structure and Content of Clinical Study Reports and relevant regulatory guidelines for preparing final study reports in clinical research.

SOP Version

Version 1.0