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

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

Speaker : Richard Chamberlain has a Ph.D. in Statistics, and He recently published a book “Planning Quality Project Management of (EMR/EHR) Software Products.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar


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

In July the FDA published a new Guidance document “Use of Electronic Health Record Data in Clinical Investigations. Guidance for Industry”.

If you use data from an EHR system in a submission to FDA it is very likely that the FDA will conduct an inspection of you data management procedures. The guidance document is not law so it leaves room for interpretation. It is very important that your company decide how to interpret the practices discussed by the FDA and how to meet the intent of the regulations.

Session Highlights

  • 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.

Instructor Profile

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, Clinical Research, 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 submissions to FDA as well as for Quality Management and Compliance to Regulations.

He recently published a book “Planning Quality Project Management of (EMR/EHR) Software Products.”

If you have problems registering or have registration questions: email us support@worldcomplianceseminars.com or call us Toll Free 844-267-7299

Register today before this event fills.

Can’t attend? Order an Audio & Reference Manual from this event.

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