Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)

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Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)

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This course covers the international Guideline ICH E2A, which relates to Clinical Safety Data Management. Sections include a review of ICH and an introduction to ICH E2A; Definitions and Terminology related to the clinical safety experience; standards for expedited reporting; reporting time frame, the procedures for reporting, managing blinded therapy cases, miscellaneous issues, and informing Ethics Committees and Investigators; and Quality Management Systems.

Course Length: 45 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. How to apply critical thinking techniques for effective implementation of the ICH E2A Guidelines.

  2. We will also reflect on how the ICH E2A global guidance affects your role in clinical research.

  3. Discuss challenges and opportunities in implementing the ICH E2A guidance.

Audience

All clinical research personnel