“Monitoring Electronic Health Records (EHRs): FAQ and - Understanding the Recent May 2016 FDA Draft Guidance - Attend the UPCOMING WEB Session”


Date: TBD

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001


In this session we will take an in depth look to the recent May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including: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

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 samsather@clinicalpathwaysresearch.com.

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Thank you!