CRA & CRC: Beginner Program
October 6-8, 2015
Boston, MA
Monitoring Clinical Drug Studies: Intermediate
October 6-7, 2015
Philadelphia, PA
Auditing Techniques for Clinical Research Professionals
October 20-21, 2015
San Francisco, CA
How to Write Great SOPs and Work Instructions
October 22, 2015
San Francisco, CA

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

Upcoming Courses
Course #: BI12219
December 1, 2015
8:30 AM - 11:00 AM Eastern

This web seminar qualifies for a reduced individual participant fee of $349. To register, call +1 781.972.5400 or toll-free in the U.S. 800.856.2556.

Course Description

Current societal events have influenced the increased use of an electronic medical record (EMR), one being the promotion of a national electronic medical record. 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 & ICH)
  • 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
  • Clinical Research Associate Managers
  • Project Managers
  • Quality Assurance Personnel


Nikki Christison, B.S., C.C.R.A.

Click here for complete trainer biographies

Registration Fees


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.

*For individual participants, this web seminar qualifies for a reduced individual participant fee of $349. To register, call +1 781.972.5400 or toll-free in the U.S. 800.856.2556.

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#: 0778-0000-14-025-L01-P. Released: 2/14. 

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