Which term represents all information in original records and certified copies necessary for reconstruction and evaluation of the trial?

• A. Source Documents
• B. Protocol
• C. Source Data
• D. SAE

Answer: (C)

Source Data are the information in original records and certified copies that are necessary to reconstruct and evaluate the trial. This includes the actual data values, measurements, observations, dates, and units as recorded at the source, which allow you to reproduce the dataset and verify results during audits. Source documents are the original records themselves (or certified copies) that contain these data; they serve as the evidence, while the source data are the values derived from them for analysis. The protocol is the study plan, and an SAE is a specific serious adverse event—neither represents the full set of data needed for reconstruction.