Monitoring Electronic Health Records (EHRs): Frequently Asked Questions - Understanding the Recent May 2016 FDA Draft Guidance - Attend the Feb 16th WEB Session


Date: February 16, 2017

Time: 10:30am - 12:00pm EST US

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up:


In this session we will take an in depth look to the May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including:

  • What is the process for certified copies?
  • What are the different requirements for sites and monitors between paper and electronic source?
  • What does the recent FDA Draft Guidance on use of EHR mean for your trials?

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
  • Common confusion points about site requirements for source documentation and sponsor monitoring of electronic health records will be discussed in detail.

For more information, contact SAM at or Laidy

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Thank you!

-The Clinical Pathways team