In GLP terminology, which term describes the data that are collected and used to assess the study's outcomes?

In GLP terminology, which term describes the data that are collected and used to assess the study's outcomes?

• A. Raw data
• B. Process data
• C. Primary results
• D. Study reports

Answer: (A)

In GLP terms, data collected in their original form during a study are called raw data. These are the actual measurements, observations, instrument readings, and notes recorded at the time of the study, before any processing or transformation. Preserving raw data is essential because it provides the unaltered basis for analyzing outcomes and for verifying results through audits and inspections. Processed data are derived from raw data after calculations or summarization, so they don’t represent the immediate observations used to assess the study’s outcomes. Primary results refer to the main findings after analysis, and study reports are the final compiled documents communicating those findings, not the original measurements themselves.

In GLP terms, data collected in their original form during a study are called raw data. These are the actual measurements, observations, instrument readings, and notes recorded at the time of the study, before any processing or transformation. Preserving raw data is essential because it provides the unaltered basis for analyzing outcomes and for verifying results through audits and inspections. Processed data are derived from raw data after calculations or summarization, so they don’t represent the immediate observations used to assess the study’s outcomes. Primary results refer to the main findings after analysis, and study reports are the final compiled documents communicating those findings, not the original measurements themselves.