INTERACTIVE DEMO AVAILABLE BELOW

From the EU Clinical Trials Directive to the Clinical Trials Regulation, the content includes an overview of the requirements for the conduct of clinical trials in the European Union, the EU Regulation and ICH E6(R2), the EU Portal and Database (Clinical Trials Information System or CTIS), highlights of the EU Regulation 536/2014 (the Clinical Trials Regulation), and running clinical trials in the EU.

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

• Knowledge Checks

• Post-Assessment

LEARNING OBJECTIVES

1. Explain an overview of how clinical trials are conducted in Europe and to recognize some major changes.

2. Discuss the transition between the Clinical Trials Directive (2001/20/EC) and the Regulation (EU No 536/2014).

3. Review the current GCP guidelines.

4. Describe the revisions to the Clinical Trial Directive.

AUDIENCE

All clinical research personnel who may want an overview of the conduct of clinical trials in the EU.

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