Raw data in GLP must be accompanied by documentation that demonstrates its traceability. Which statement best describes this requirement?

• A. Clear linkage to source documents and protocol procedures.
• B. Only final numbers are needed.
• C. No documentation is required.
• D. Data be summarized before storage.

Answer: (A)

The main idea here is that GLP requires raw data to be traceable to its origin. The best description is that raw data must have a clear linkage to source documents and protocol procedures. This means every data point can be traced back to the original observation and the exact method used to obtain it, with records showing who performed the work, when it was done, and how the data were generated.

Linking to source documents and protocol procedures helps ensure data integrity, facilitates audits, and supports reproducibility. Source documents can include lab notebooks, instrument printouts, calibration records, and data collection forms, while protocol procedures describe the steps, reagents, equipment settings, and conditions used.

Providing only final numbers omits how those numbers were produced and any changes or judgments along the way, and having no documentation at all defeats the purpose of traceability. Similarly, summarizing data before storage obscures the original observations and breaks the ability to verify the data lineage.