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.
- 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
- Clinical Research Coordinators
- Device and Drug Study Clinical Research Associates and Managers
- Project Managers
- Quality Assurance Personnel
Janet Ellen Holwell, C.C.R.C., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.