Good Clinical Practice - ICH Guidelines E6 R2

Name: Good Clinical Practice - ICH Guidelines E6 R2
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Gain critical information about good clinical practice (GCP) in conducting safe clinical trials in this free course.

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Learning Outcomes

In this free course, you will learn how to:

Identify the role of ICH and the duties of its working groups
Discuss GCP requirements regarding conducting a clinical trial
Evaluate the team configuration of IECs and IRBs
Recall the primary responsibilities and procedures of IECs and IRBs
Define ICH's GCP requirements concerning communication with IRBs, and the responsibilities of trial conductors
Discuss the method of taking consent from the trial's subjects
Recognize GCP record-keeping requirements for a clinical trial
Indicate the responsibilities of the trial's sponsors in financing the trial's subjects
Recall how the sponsor will report any adverse events to the regulatory authorities
Outline guidelines about trial protocols and subject treatment protocol
Discuss the concept of good clinical practice
Identify the importance of quality management and the role of a Clinical Research Organization

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