Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures

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FD and Part 11_Full_Thumbnail.jpg

Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures

$199.00

To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.

Course outline HERE

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INTERACTIVE DEMO AVAILABLE BELOW

This course covers Overview of 21 CFR Part 54 Financial Disclosure and Part 11 Electronic Data Signatures. This course’s main topics are financial disclosure, electronic records, and electronic signatures under FDA’s 21 CFR Part 54 and Part 11. These topics are applicable to drug, device, and biologic studies. Required by Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. Part 11 describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.

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

  • Knowledge Checks

  • Post-Assessment

LEARNING OBJECTIVES

  1. Apply critical thinking techniques for effective implementation of 21 CFR Part 54 and Part 11.

  2. Reflect on how 21 CFR Part 54 and Part 11 affect your role in clinical research.

  3. Discuss challenges and opportunities in implementing 21 CFR Part 54 and Part 11.

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