GCP: How to Obtain Approval to Conduct Clinical Trials in the EU

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Program/Course ID: GCP20 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: Overview: The requirements for CTA and EC favorable opinion are introduced, and the scope and learning objectives of The course are specified. The European context: The EU regulatory environment is described, the Clinical Trials Directive is introduced, and the requirements on clinical trials are summarized. Applying for approval: The required contents of the two submissions are summarized, and the main steps in the application processes are set out. The CTA application: The main elements of the CTA application are described, particularly the Investigator's Brochure and the Investigational Medicinal Product Dossier, and the data required are discussed. The timelines of the application process are specified. The EC application: The key components of the EC application are described, particularly the clinical protocol and documents relating to patient recruitment and informed consent. The timelines of the application process are specified. Maintaining a CTA: The procedures necessary to maintain authorization are described, particularly the submission of amendments and the reporting of adverse reactions. Summary: Key point summary of topics covered in The course. Ideal for review, a refresher, or consolidation of learning.		Objectives: Students completing this course should be able to: Explain what a Clinical Trial Authorization (CTA) application is, why it is required, and to which bodies it should be submitted. Explain what an application for an Ethics Committee (EC) Opinion is, why it is required and to which bodies it should be submitted. Describe the regulatory environment governing CTA applications and access the key regulatory documents. Summarize the information that should be included in the CTA and EC applications.

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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	GCP: How to Obtain Approval to Conduct Clinical Trials in the EU