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.
- 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
- Implement contingency planning for electronic source document deficiencies
- Manage site and sponsor activities regarding electronic medical records
- Clinical Research Coordinators
- Device and Drug Study Clinical Research Associates
- Clinical Research Associate Managers
- Project Managers
- Quality Assurance Personnel
Nikki Christison, B.S.
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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 1-800-856-2556 for pricing.
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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-011-L01-P. Released: 3/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.