Monitoring Electronic Health Records (EHRs): Frequently Asked Questions - Understanding the Recent May 2016 FDA Draft Guidance

Date: February 16, 2017
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

UPDATE: This course will include discussion of the recent FDA Draft Guidance on use of Electronic Health Records in Clinical Trials!!!!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  • What does the recent FDA Draft Guidance on use of EHR mean for your trials?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?

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


This course will be of benefit to anyone responsible for complying with the GCPs related to source documentation and use of electronic systems, and those who work with these groups. Also, those involved in site selection, contract budget development, monitoring, and compliance will benefit greatly from this course.

Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC).  She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).