Electronic Medical Records Trailer

Current societal events have influenced the increase use of electronic medical records, one being the promotion of a national electronic medical record. More and more research sites are using an electronic medical record (EMR) for all or part of their case histories for research subjects. The industry has defined the characteristics that source documents in any form must include, and 21 CFR Part 11 includes standards for electronic source data. Challenges in monitoring the original source document have been growing and unaddressed in many situations. FDA's release of a final guidance document for 21 CFR Part 11 supports certain characteristics that EMRs should include, but many site electronic records do not meet the requirements. This course will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.

Category:

Science & Technology

Tags:

• Electronic
• Medical
• Records
• Trailer
• EMR
• Clinical
• 21
• CFR
• Part
• 11