The Code of Federal Regulations (CFR) outlines the rules and regulations established by the Food & Drug Administration (FDA) concerning electronic records and electronic signatures. Specifically, 21 CFR Part 11 sets forth the criteria to ensure the trustworthiness, security, and reliability of systems and processes related to electronic records and signatures. Provided below are resources from Duke School of Medicine to guide compliance with 21 CFR Part 11 in clinical research.
This site includes a FAQ as well as compliance statements for various clinical research systems at Duke. Information provided here is specific to Duke, and cannot necessarily be applied to the same systems hosted at other institutions or research sites.
General Tools and Information
- Letter from DHTS to FDA stipulating electronic signatures may be used in place of wet-ink signatures
- For 21 CFR Part 11 Compliance questions, please contact part11@duke.edu
Research System-specific Information
| System | Link |
|---|---|
| Advarra eReg | Duke eReg Validation Memo (7.13.2022) |
| OnCore | Duke OnCore Validation Memo (7.13.2022) |
| REDCap | Duke REDCap Validation Memo (1.10.2023) |
| Adobe Sign | Duke Adobe Sign Validation Certificate (2.18.2022) |
| Epic | Duke EMR Part 11 Compliance Memo (1.16.2023) |
| iRIS | Duke iRIS Validation Memo (7.13.2022) |