A study is using an EDC system.

After data entry into the Electronic Data Capture (EDC) system, the monitor (typically a Clinical Research Associate - CRA) conducts Source Data Verification (SDV). The monitor compares the data entered in the EDC system with the source documents to ensure accuracy, completeness, and consistency. This step is essential for maintaining data integrity and compliance with GCP standards.

GCP guidelines require that monitors verify data accuracy through SDV as part of routine monitoring responsibilities.

"The monitor is responsible for performing Source Data Verification (SDV) to ensure that the data recorded in the EDC system matches the source documents."

Objectives:

Verify data accuracy in clinical trials.

Ensure compliance with data management protocols.