Monitoring Electronic Health Records (EHRs): ALCOA vs. 21 CFR Part 11 Compliance
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Date: February 27, 2014
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online Course
Course Description: This course will provide attendees with clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR). Common confusion points about site requirements for source documentation and sponsor monitoring of electronic health records will be discussed in detail.
Attend this interactive live session and you will come away with:
- Answers to frequently asked questions regarding monitoring electronic health records (e.g., access, HIPAA Privacy, Part 11, documentation, and more).
- The ability to identify acceptable approaches to monitoring EHRs in compliance with GCPs and privacy regulations (e.g., direct access vs. certified copies).
- The skills to recognize essential site and sponsor agreements, and the training needed before site selection and monitoring an EHR A detailed understanding of the logistics for remote monitoring of source documents.