Which statement best describes what is retained in an archive under GLP regulations?

• A. Only final reports are retained
• B. Raw data and other associated records are retained
• C. Only digital data is retained
• D. Data can be discarded after submission

Answer: (B)

GLP requires that archives preserve the actual data collected during a study along with the records that show how the study was conducted and analyzed. This means keeping raw data, instrument readouts, worksheets, raw observations, calculations, and the study protocols and reports that document the plan and results. Retaining these materials allows someone reviewing the study to reconstruct what happened, verify calculations, and understand how conclusions were drawn. That’s why raw data and other associated records are kept.

Keeping only final reports omits the data and materials needed to verify results. Retaining only digital data ignores non-digital records and the context of how data were collected. And discarding data after submission would undermine the ability to audit and verify the study.