Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

4/06/2021

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Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB interactive eLearning is now available for purchase in our online store HERE. The interactive eLearning course provides an overview of the key concepts and best practices for maintaining human subject protection (HSP) by following the U.S. Food and Drug Administration’s (FDA) applicable regulations. Conduct of a clinical trial involving human subjects includes considerations to protect their rights and safety. Ensuring HSP is a core principle of Good Clinical Practice (GCP) and is required by regulatory authorities. Understanding how to implement these FDA regulations applicable to clinical research is key to a successful and ethical clinical trial.

Content includes:

  • Key components of human subject protection,

  • Definitions and scope for Part 50,

  • Informed consent requirements, elements, and language;

  • The informed consent process;

  • Exceptions to informed consent;

  • Vulnerable populations; and

  • 21 CFR 56 - the regulation section for Institutional Review Boards.

Learning Objectives

  1. Apply critical thinking techniques for effective implementation of 21 CFR Part 50 and 56.

  2. Learn how 21 CFR Part 50 and 56 affect your role in clinical research.

  3. Discuss challenges and opportunities in implementing these regulations.

Includes:

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

  • Scenarios

  • Knowledge Checks

  • Post Assessment

  • Certificate of completion

Audience

A foundation training applicable for all clinical research professionals involved with conduct of clinical trials in the United States.

Onboarding or Annual Review Curriculum

This course can be used alone or as part of the full curriculum, including:

  1. GCP Training: ICH E6(R2) - Available HERE

  2. Good Documentation Practices and ALCOA-C - Available HERE

  3. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE

  4. Structure and Content of Clinical Study Reports (ICH E3) - Available HERE

  5. Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE

  6. Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE

  7. Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - Coming Soon!

 

Customization Available

A customized curriculum can be developed for clinical research stakeholders such as sponsors Our courses are also offered as webinars or online workshops. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.

Enterprise Pricing Available

Off the shelf pricing for over 10 licenses from the store is available when you contact us at info@clinicalpathwaysresearch.com.

Want training for longer than the license timeframe but do not have an LMS? Clinical Pathways can host annual training in our LMS to support your learners, with reports and certificates of completion for audit readiness.

- The Clinical Pathways Team

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