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Good Clinical Practice


Overview

Gain the basic knowledge required to conduct clinical trials, including information about subject safety, regulations, and the practicalities of performing clinical research studies. This module includes information about the recently adopted ICH GCP E6(R2) guideline.  Learn through an interactive case study, knowledge checks, and flashcards.

Featured topics

  • GCP, Roles, Terms, and Origins
  • GCP Requirements, Regulations, Guidances and History
  • The Role of the Investigator
  • The Role of the Study Staff, sponsor and IRB
  • Aspects of GCP : Informed Consent; Adverse Event Handling and Reporting

Who should attend?

  • Clinical investigators
  • Clinical research professionals
  • Sub-investigators
  • IRB personnel
  • Study staff

Learning objectives

Upon completion of this module, learners should be able to:

  • Identify the roles and responsibilities of each member of the study team including the clinical investigator, sub-investigator, study staff, IRB, and sponsor
  • Apply the regulations and guidelines for conducting safe and effective clinical trials
  • Describe the various processes for informed consent
  • Describe the requirements in reporting adverse events

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