What is the primary purpose of Source Data Verification (SDV)?

What is the primary purpose of Source Data Verification (SDV)?

• A. Verifying that data in the CRF matches the source documents
• B. Ensuring the source documents are filed correctly
• C. Auditing the sponsor’s finances
• D. Verifying patient consent

Answer: (A)

SDV is about ensuring data integrity by verifying that what’s recorded in the Case Report Form truly reflects what is in the original source documents, such as medical records, lab results, or imaging reports. This means checking that values, dates, events, and outcomes are accurate, complete, and consistently documented across the CRF and the source. By catching and correcting discrepancies, SDV helps guarantee reliable trial results and regulatory acceptability. It isn’t about filing source documents (that’s document management), nor about auditing sponsor finances, and while consent information lives in source documents, the primary aim of SDV is the accuracy of the data captured in the CRF.

SDV is about ensuring data integrity by verifying that what’s recorded in the Case Report Form truly reflects what is in the original source documents, such as medical records, lab results, or imaging reports. This means checking that values, dates, events, and outcomes are accurate, complete, and consistently documented across the CRF and the source. By catching and correcting discrepancies, SDV helps guarantee reliable trial results and regulatory acceptability. It isn’t about filing source documents (that’s document management), nor about auditing sponsor finances, and while consent information lives in source documents, the primary aim of SDV is the accuracy of the data captured in the CRF.