Clinical data management electronic data capture
- 2. • Guidelines in Discrepancy Management • Query • Dara clarification forms • Interim Analysis • SAE Reconciliation • 2 principles of Data Management: Data Quality (accuracy and authenticity) and Data Integrity ( chain of custody) • Source documents (originality) • Trial Planning • Regulated trials • Non regulated trials • Declaring data as clean
- 5. Major Stake Holders of a Trial and their roles and responsibilities • • SPONSOR • CRO • Patients • Investigators • Regulatory Bodies
- 6. Where can we get clinical data? • • Clinical trials data. • Clinical data falls into six major types: • Electronic health records. • Administrative data. • Claims data. • Patient / Disease registries. • Health surveys/health camps
- 7. Data entry – previous slide Types of problem in Data collection Missing Data Incorrect data Excess Variability
- 8. Methods of Data Capture • OCR (Optical Character Recognition) • OMR (optical mark recognition) • Intelligent Character Recognition (ICR ) • Bar code recognition • Template-based intelligent capture • Intelligent Document Recognition (IDR) • Electronic Data Capture (EDC)
- 9. Remote data entry Ex: Oracle Clinical Remote Data Capture (RDC) is an electronic data capture (EDC
- 10. EDC (1980S) – Rave Features Centralized Administration Manage all users through cloud administration. Real time data validation Ensure data is correct at the time of entry . Streamlined data review See what tasks are outstanding in the task overview dashboard. Intelligent coding Code terms automatically or manually with coding suggestions through rave coder. Reporting and analytics Make informed decision one click access from reports Interoperability Ingest data from or extract data to, any external system
- 11. Data privacy