Source data verification (SDV) should be thought of as more than simply a blind consistency check between source and eCRF. Its primary purpose is indeed to verify that the information transcribed into the eCRF is complete and consistent with source records, but also that eCRF and source together meet the study protocol and clinical expectations. Genius eSOURCE™ improves monitoring efficiency and productivity and reduce significantly site monitoring visits required since it:
- Allows the easy upload of electronic certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the remote and immediate SDV
- Accepts source records in many digital formats, including but not limited to PDF, Word, XML, DICOM files and others
- Assures, via a specific data anonymization technique, the confidentiality and privacy of personal identifiable information
- Doesn’t allow any download, printing or copying of the source documents
- Allows full interoperability with RBM for real-time risk analysis and to CTMS for timelines and operational performance metrics review
- Is accessible only to the relevant site monitors for remote SDV and data quality control
- Cuts site monitoring time by nearly 40%
- Reduces the number of site monitoring visits by nearly 60%
- Cuts site monitoring costs by nearly 50%
