In GLP, which document should contain a full description of what constitutes raw data that is collected?

• A. The protocol
• B. The final report
• C. The SOPs
• D. The archive index

Answer: (A)

The protocol sets up what will be collected and how, including exactly what counts as raw data for the study. In GLP, raw data are the original observations and measurements as recorded during the study, before any processing. The protocol describes the study design, the data to be collected, the instruments or methods used, units, timestamps, data sheets, and recording procedures. By specifying these details, it creates a clear standard for what constitutes raw data for that particular study, ensuring traceability back to the original source and enabling proper data integrity and auditability. The final report summarizes results and does not define raw data, SOPs describe procedures and data handling practices in general, and the archive index deals with storage and retrieval of records after the study.