Electronic Medical Records Source of Data in Clinical Investigation
Project Founder: Dr. Andrew Bier Project Leader: Luis Magalhaes
- PROBLEM STATEMENT
- There is a knowledge gap in ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.
- Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations.
- Facilitate the use of EHR data in clinical investigations.
- Promote the interoperability of EHR and EDC systems.