This course will include discussion of the recent FDA Draft Guidance on use of Electronic Health Records in Clinical Trials!
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. Common questions to be addressed include:
What does the recent FDA Draft Guidance on use of EHR mean for your trials?
- What should the sponsor do when working with a site that does not allow access to original source documents found within an EHR?
- How does the HIPAA Privacy Rule impact the accessibility of original source when found in an EHR?
- What is the process for certified copies?
- What are the different requirements for sites and monitors between paper and electronic source?
At the conclusion of this 90-minute session, participants will be able to:
- 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