Now Available for Purchase: Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures eLearning

4/20/2021

FD and part 11 blog pic.PNG

Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures interactive eLearning is now available for purchase in our online store HERE.

This interactive eLearning can be used alone or as part of the full curriculum (see more below).

The course provides an overview of the key concepts and best practices for following the U.S. Food and Drug Administration’s (FDA) applicable regulations for financial disclosure, electronic records, and electronic signatures. These topics are applicable to drug, device, and biologic studies. Required by 21 CFR Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. 21 CFR Part 11describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.

Content includes:

  • Key components of financial disclosure including whose responsibility it is to submit,

  • Differences between filing certification versus disclosure,

  • Definitions and scope for Part 54,

  • FDA guidance related to financial disclosure,

  • Background on computerized systems and electronic source data,

  • FDA guidance related to Part 11,

  • Regulatory expectations for following Part 11 requirements and how it links back to good documentation practices and ALCOA-C.

Learning Objectives

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

  2. Reflect on how the regulations and standards affect your role in clinical research.

  3. Discuss the challenges and opportunities in implementing the regulations.

Includes:

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

  • 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 – Available HERE

Customization Available

A customized curriculum can be developed for clinical research stakeholders such as sponsors. Our courses can also be 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.

Want to save 5%? Sign up for our newsletters!

By signing up, you agree to our our Privacy Policy. You may unsubscribe from emails at any time.

- The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.