What does Source Data Verification (SDV) involve?

What does Source Data Verification (SDV) involve?

• A. Verifying that data in the CRF matches the source documents
• B. Auditing the trial budget
• C. Verifying IP inventory
• D. Training site staff

Answer: (A)

SDV is the process of confirming that the data entered into the Case Report Form matches the information in the source documents, such as medical records, lab reports, and consent forms. This data verification ensures accuracy, completeness, and consistency of trial data, which is essential for reliable analysis and regulatory submissions. Monitors compare CRF entries with the original records, document any discrepancies, and ensure they are corrected in a timely manner, often focusing on a data sample or high-risk items depending on the monitoring approach. It is not about auditing the trial budget, managing IP inventory, or training site staff, which are separate activities focused on finances, drug supply, and staff competency, respectively.

SDV is the process of confirming that the data entered into the Case Report Form matches the information in the source documents, such as medical records, lab reports, and consent forms. This data verification ensures accuracy, completeness, and consistency of trial data, which is essential for reliable analysis and regulatory submissions. Monitors compare CRF entries with the original records, document any discrepancies, and ensure they are corrected in a timely manner, often focusing on a data sample or high-risk items depending on the monitoring approach. It is not about auditing the trial budget, managing IP inventory, or training site staff, which are separate activities focused on finances, drug supply, and staff competency, respectively.