ABSTRACT

To ensure that the data captured in the CRFs are accurate and complete, the Monitor will verify that all data captured in the CRF are supported by source documentation and will check the CRF to determine the following: 1. Are all pages present and in the correct order? 2. Do all blanks for data have complete entries? 3. Is the subject identifier on each page? 4. Are the data legible? 5. Are the dates present and is the sequence of dates logical? 6. Are the data logical and consistent? 7. Are errors properly corrected?