INTERACTIVE DEMO AVAILABLE BELOW

This course covers an Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC. 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.

This course can be used alone or as part of the full curriculum; for more information refer to the additional information below.

Course Length: 45 minutes

INCLUDES:

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

• Certificate of completion

• Case Studies

• Post-Assessment

• Knowledge Checks

LEARNING OBJECTIVES

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

2. Learn how these sections of the regulations affect your role in clinical research.

3. Discuss challenges and opportunities in implementing these regulations.

AUDIENCE

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

INTERACTIVE DEMO:

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 - HERE