SOP Guide for Pharma

SOP for Final Report Preparation

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

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

Documents

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

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