Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

Course Description

Current societal events have influenced the increased use of an electronic medical record (EMR), one being the promotion of a national EMR. More and more research sites are using an 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. The FDA’s 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 web seminar will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.

Learning Objectives

• Define source documents (FDA and ICH GCP E6 Guideline)
• Explain required characteristics for source documents in any form
• Describe requirements of electronic source documents (21 CFR Part 11)
• Apply these concepts to electronic medical records at research sites
• Apply contingency planning for electronic source document deficiencies
• Manage site and sponsor activities regarding electronic medical records

Who Should Attend

• Investigators
• Clinical Research Coordinators
• Device and Drug Study Clinical Research Associates and Managers
• Project Managers
• Quality Assurance Personnel

Instructor

Denise Redkar-Brown, MT

Click here for complete trainer biographies

Registration Fees

$835

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 778-0000-23-056-L99-P. Released: 7/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.