Which term refers to the original documents, data, and records used during a clinical trial?

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

Answer: (B)

In GCP, the term for the original records that contain the information used to generate trial data is source documents. These are the actual papers or electronic records where data are first recorded—examples include hospital charts, lab reports, imaging studies, medical and consent forms, and electronic health records. They provide the first-hand evidence of what happened to a participant and serve as the source against which data in the case report form are verified. This linkage allows proper source data verification and audit trails, helping ensure data integrity and regulatory compliance. The protocol is the study plan, not the records of what happened, and a serious adverse event is a specific safety outcome, not the general term for data sources. While some people refer to the data values as source data, the original documents themselves are called source documents.