The Use of EHR Data in Clinical Investigations (Research) – FDA’s Latest Guidance

01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

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EHR system in a submission to FDA

Description

For several years many hospitals and other healthcare organizations have been implementing Electronic Health Records (EHR) computer systems to record and manage their medical information.

During a clinical trial the sponsor will likely have an Electronic Data Capture (EDS) system to record the clinical data. This may mean that the data would be entered twice – once in the EDC system and once in the EHR system. Besides generating a lot more work, there are serious data reliability issues when the data is entered twice.

The developers of the EHR systems have done a considerable amount of work to assure more quality in the medical information. This includes things like Standards that all of the systems are required to follow and Interoperability which assures that they can share information between systems reliably.

Why Should You Attend:

For several years many hospitals and other healthcare organizations have been implementing Electronic Health Records (EHR) computer systems to record and manage their medical information.

During a clinical trial the sponsor will likely have an Electronic Data Capture (EDS) system to record the clinical data. This may mean that the data would be entered twice – once in the EDC system and once in the EHR system. Besides generating a lot more work, there are serious data reliability issues when the data is entered twice.

The developers of the EHR systems have done a considerable amount of work to assure more quality in the medical information. This includes things like Standards that all of the systems are required to follow and Interoperability which assures that they can share information between systems reliably.

Areas Covered

•         What is an EHR System?
•         What “standards” do EHR systems follow?
•         The role of Computer Systems Validation and 21 CFR Part 11?
•         The use of data in an EHR in clinical research.
•         Interoperability between the various clinical computer systems

Who will Benefit

•        Those in the hospital or clinic that are responsible for preparing and managing the data both for the patient                care and the clinical research.
•        Those in the clinical research sponsor who have the responsibility for building the database for the clinical                  research.
•        Those who will have to defend the accuracy of the clinical research information to the patients and the                        regulatory body.

Industries who can attend

This 90-minute online course is intended for professionals in the all Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Richard Chamberlain

Richard Chamberlain has a Ph.D. in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, Data Management, computerized project scheduling, strategic planning, and Quality Management.

He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations.

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