INTERACTIVE DEMO AVAILABLE BELOW

The use of electronic systems to support critical endpoint and safety data continues to increase. A clinical eSystem is an electronic system used to support the clinical trial, such as to collect, handle, and manage clinical trial data, manage investigational product, or informed consent. Clinical eSystem is not a regulatory term, but the FDA regulates electronic systems, electronic records, and electronic signatures used to create records required for studies per 21 CFR Part 11. Part 11 is a companion regulation to other FDA regulations and laws called “predicate rules,” where specific requirements for recordkeeping, record content, signatures, and record retention are addressed. Part 11 is complex, and guidance documents have been published for sponsors and CROs to understand how to maintain compliance. Sponsor oversight of the electronic systems used by CROs and sites is not only a best practice to ensure quality data and participant safety but also is a regulatory requirement.

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. Recognize the requirements for eSystems used in a clinical trial and the sponsor’s responsibilities to ensure compliance.

2. Apply the eSystems regulations to identifying what inspection readiness activities are needed.

3. Discuss common pitfalls and tips for success.

AUDIENCE

All clinical research personnel involved with electronic systems or electronic signatures used to support clinical trials.

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