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European Biopharmaceutical Review

What Happens Next? Understanding the New FDA Guidelines for Digital ECG and Similar Data

Q What was the purpose of the November FDA meeting?

A The FDA held a meeting to collect information about a proposed new format and its content, for the submission of electrocardiographic (ECG) and other data in support of new pharmaceutical drug applications. The FDA announced its desire to receive ECG waveform data in an electronic digital format and to receive 'annotations' on the electronic data to indicate such events as standard ECG interval onsets and offsets.

Q What is the rationale for the FDA requesting electronic digital waveform information along with the other standard ECG information typically submitted now?

A FDA representatives noted that the FDA was always within its rights to request hard copy ECGs which were performed in a study. By defining an electronic format for ECG waveform data, the FDA is simply taking advantage of current technology to make this sort of information readily available on a routine basis. In addition, by also requesting that the waveforms be annotated, the FDA is establishing a mechanism to allow it to determine if the interval measurements which were reported can be verified by the sponsor submitting the data. This will therefore allow the FDA to make its own judgments about the ECG interval measurements and findings. The FDA specifically did not announce a preference for any particular method of measuring the ECG waveforms at the meeting.


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In Conversation with Kevin J. Klingler, President of the
Pharmaceutical Division of Biomedical Systems Corporation

Kevin J. Klingler is President of the Pharmaceutical Division of Biomedical Systems. He has been with Biomedical Systems for 19 years and has been involved with the clinical trial industry for the past 16 years. In his current capacity, Kevin oversees the centralised diagnostic services provided to pharmaceutical and biotechnology companies, device manufacturers and contract research organisations in Phase I-IV trials around the world.
Kevin has spoken at many pharmaceutical industry conferences around the world, has participated in roundtable discussions at numerous meetings, and in October 2002 will be co-chairing the DIA-Sponsored 'ECGs in Clinical Trials' seminar. He received his BS in Finance and Masters in Business Administration from St. Louis University, USA.

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Kevin J. Klingler
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