ICH GCP E6 R2 Refresher

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ICH GCP E6 R2 Refresher

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This ICH GCP E6 R2 Refresher (GCP) course reviews key components of the requirements of GCP for clinical trials found in ICH E6 (R2) related to the role and responsibilities of the investigator, sponsor, and other stakeholders. It also covers an overview of GCP, then moves on to review major regulatory agencies in the United States, the European Union, and Japan, then reviews essential documentation, and finally covers good documentation practices including ALCOA-C.

Course Length: 90 minutes

Interactive Demo:

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Includes:

  • Unlimited access to the content for 45 days from your initial day of purchase.

  • Certificate of completion

  • Case Studies

  • Post-Assesment

  • Knowledge Checks

Objectives

  1. Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6 R2.

  2. Discover how the ICH global guideline affects your role.

  3. Reflect on challenges and opportunities in implementing the GCP Guideline.

  4. Identify practical applications of the guideline in your work processes including identifying methods to assess quality systems, and documentation.

Audience

All clinical research personnel