INTERACTIVE DEMO AVAILABLE BELOW

This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relating to IND Definitions, Part 312 – Subpart D about Responsibilities of Sponsors and Investigators, parts of 21 CFR Part 314 –NDA as it relates to clinical operations, and other essentials regarding cross functional readiness.

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

Course Length: 60 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 21 CFR Part 312 and 314.

2. Learn how 21 CFR Part 312 and 314 affect your role in clinical research.

3. Discuss challenges and opportunities in implementing 21 CFR Part 312 and 314.

AUDIENCE

All clinical research personnel

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