What is a monitor's duty regarding CRF entries and source documents?

• A. Checking the accuracy and completeness of CRF entries against source documents
• B. Ignoring CRFs if source documents are present
• C. Filing CRFs without dates
• D. Deleting inconsistencies in the CRF without documentation

Answer: (A)

The monitor is responsible for ensuring data integrity by performing source data verification. This means checking that the information entered on the CRF is accurate and complete by comparing it directly with the original source documents (such as medical records, lab reports, and other source data). When discrepancies or missing data are found, the monitor should raise formal CRF queries and ensure that any corrections are documented, dated, and traceable so there is a clear audit trail. This careful alignment between CRF entries and source documents is what supports reliable, verifiable study data and regulatory compliance. Ignoring CRFs when source documents exist, dating or logging edits inconsistently, or deleting inconsistencies without documentation would undermine data quality and the study’s integrity.