What is source data in clinical trials?

What is source data in clinical trials?

• A. Original records or certified copies containing the data that support trial findings
• B. The study protocol
• C. The trial budget
• D. The final publication

Answer: (A)

Source data are the original records or certified copies that contain the data used to support the trial findings. They are the first place where information about a participant is recorded—such as patient charts, hospital records, lab worksheets, or electronic files that originate from the source document—before it’s entered into the case report forms. Regulators require that data in the study be traceable back to these source documents, and you verify this by comparing the CRF data to the source data to ensure accuracy and integrity. The study protocol describes how the trial is run, the budget covers finances, and the final publication presents the results, not the raw data used to derive them.

Source data are the original records or certified copies that contain the data used to support the trial findings. They are the first place where information about a participant is recorded—such as patient charts, hospital records, lab worksheets, or electronic files that originate from the source document—before it’s entered into the case report forms. Regulators require that data in the study be traceable back to these source documents, and you verify this by comparing the CRF data to the source data to ensure accuracy and integrity. The study protocol describes how the trial is run, the budget covers finances, and the final publication presents the results, not the raw data used to derive them.