Standard Operating Procedure for Data Analysis and Interpretation

Purpose

This SOP outlines the procedures for conducting statistical analysis and data interpretation in clinical trials and clinical studies. The goal is to ensure the accuracy, consistency, and integrity of data analysis, providing reliable results to support study objectives and conclusions.

Scope

This SOP applies to all personnel involved in statistical analysis and data interpretation, including statisticians, data analysts, principal investigators, and study sponsors.

Responsibilities

• Principal Investigator (PI): Oversees the analysis process and ensures that data interpretation aligns with study objectives.
• Statisticians: Conduct the statistical analysis as outlined in the statistical analysis plan and interpret the results.
• Data Management Team: Provides the data sets required for analysis and ensures data integrity.
• Study Sponsors: Provide resources and support for statistical analysis and data interpretation.

Procedure

• Statistical Analysis Plan (SAP):
  • Develop a statistical analysis plan that outlines the methods and procedures for data analysis, including statistical tests and models to be used.
  • Ensure the SAP is aligned with the study protocol and objectives.
• Data Preparation:
  • Prepare data sets for analysis, ensuring data quality, accuracy, and completeness.
  • Verify data integrity and consistency through data cleaning and validation checks.
• Statistical Analysis:
  • Conduct statistical analysis according to the SAP using appropriate software and statistical methods.
  • Perform sensitivity analyses, subgroup analyses, and exploratory analyses as needed.
• Data Interpretation:
  • Interpret the results of the statistical analysis in the context of the study objectives and protocol.
  • Discuss findings, limitations, and potential implications of the results.
• Quality Control:
  • Conduct quality control checks on statistical outputs and data interpretations to verify accuracy and consistency.
  • Document any issues or discrepancies and address them promptly.
• Reporting:
  • Prepare reports and summaries of the statistical analysis and data interpretation.
  • Provide reports to the PI, study sponsors, and other stakeholders as required.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• SAP: Statistical Analysis Plan

Documents

• Statistical analysis plan (SAP)
• Data sets and data management records
• Statistical output reports
• Data interpretation and summary reports

References

• Institutional policies for statistical analysis and data interpretation
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0