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.
- AIM
- Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations.
- OBJECTIVE
- Facilitate the use of EHR data in clinical investigations.
- SOLUTION
- Promote the interoperability of EHR and EDC systems.
If you would like to learn more or be a part of this PFP Project, please contact us:
- Project Founder:
- Dr. Andrew Bier
- Project Leader: Luis Magalhaes
- Contact: [email protected]
- Get Involved