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ECG & Holter Data


Regulatory authorities require cardiac safety data to be collected during all clinical phases of the development of a new drug. This module will explain the types of cardiac safety data which the FDA and other regulatory authorities typically expect to be collected through ECGs and Holters.

By the end of this course you will be able to:

  • Understand the terminology used in ECGs and Holters
  • Explain what data is available from an ECG
  • Explain what data is available from a Holter
  • Understand the difference between an ECG and a Holter
  • Be able to assess and appropriately evaluate the ECG and Holter requirements stated in a protocol


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