Which statement about source data is true?

Which statement about source data is true?

• A. Source data are the final publication data
• B. Source data are the original records or certified copies containing the data that support trial findings
• C. Source data are only data entered into the CRF
• D. Source data are regulatory submission documents

Answer: (B)

Source data are the original records or certified copies that contain the data supporting the trial findings. These are the raw pieces of information collected during the trial—such as hospital records, lab reports, patient diaries, imaging results, or data from electronic source systems—that form the basis for what is later entered into the CRF and analyzed. They provide the traceability needed to reconstruct and verify results. The final publication data are what you get after cleaning, coding, and statistical analysis, not the raw records themselves. Source data are not limited to what’s entered into the CRF, since the CRF is a processed representation and may omit context found in the source. They are also not regulatory submission documents, which are prepared for regulators and review rather than serving as the primary basis for trial findings.

Source data are the original records or certified copies that contain the data supporting the trial findings. These are the raw pieces of information collected during the trial—such as hospital records, lab reports, patient diaries, imaging results, or data from electronic source systems—that form the basis for what is later entered into the CRF and analyzed. They provide the traceability needed to reconstruct and verify results. The final publication data are what you get after cleaning, coding, and statistical analysis, not the raw records themselves. Source data are not limited to what’s entered into the CRF, since the CRF is a processed representation and may omit context found in the source. They are also not regulatory submission documents, which are prepared for regulators and review rather than serving as the primary basis for trial findings.