Which term refers to the document that records data collected in a clinical trial?

• A. Input Screen Design
• B. Source Document
• C. Output Screen Design
• D. Data Type

Answer: (B)

In clinical trials, the document that records data collected is called a Source Document. It serves as the original record for a participant’s data (such as hospital charts, lab reports, or nurse notes), providing the evidence from which data are verified and later entered into the study records. This source data can then be compared against the data captured on the Case Report Form to ensure accuracy and traceability. The other terms refer to different ideas: designing the tools you use to enter data (Input Screen Design) or display results (Output Screen Design), or simply describing the kind of data (Data Type), none of which define the actual original record of data collection.