Current societal events have influenced the increase use of electronic medical records, one being the promotion of a national electronic medical record. More and more research sites are using an electronic medical record (EMR) for all or part of their case histories for research subjects. The industry has defined the characteristics that source documents in any form must include, and 21 CFR Part 11 includes standards for electronic source data. Challenges in monitoring the original source document have been growing and unaddressed in many situations. FDA's release of a final guidance document for 21 CFR Part 11 supports certain characteristics that EMRs should include, but many site electronic records do not meet the requirements. This course will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.
- Define source documents (FDA & ICH)
- Explain required characteristics for source documents in any form
- Describe requirements of electronic source documents (21 CFR Part 11)
- Apply these concepts to electronic medical records at research sites
- Implement contingency planning for electronic source document deficiencies
- Manage site and sponsor activities regarding electronic medical records
- Investigators and CRCs
- Device and Drug Study CRAs
- CRA and Project Managers
- Quality Assurance
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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2.5 hours; 9:00 - 11:30 p.m. Eastern
April 19 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471