What term describes 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)

In GCP, the term that describes all information in original records and certified copies necessary for reconstruction and evaluation of the trial is Source Data. This concept focuses on the actual data points and information found in the source records that allow you to reconstruct how the trial was conducted and to verify its results. It’s not the plan of the study (that’s the protocol) or the records themselves as documents (that’s Source Documents). Examples include lab results, imaging measurements, clinician notes, and other data contained in the original records used to support data kept in case report forms. The definition explicitly ties the data to the ability to reconstruct and evaluate the trial, which is why this term fits best.