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Friday, November 13, 2026
Home » Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

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

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU  Certification Training

 
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Program/Course ID:GCP020
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials & activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Outline/Syllabus:Click here to view training outline.
LMS Compatible: SCORM-compliant; request a quote.
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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Outline:


Overview
An outline of the module's scope and objectives, and notes on terminology.

The European context
This session explains the legal and regulatory framework for clinical trials in Europe.

Applying for approval
This session outlines the application procedures for clinical trial authorization (CTA) and for ethics committee (EC) favorable opinion. It provides a decision tree through which you can determine whether your prospective investigation is a clinical trial. It describes how to register a trial with the EudraCT database and obtain a EudraCT number. It summarizes the contents of applications and the processes and outcomes of reviews.

Application for clinical trial authorization
The contents of a CTA application are discussed in more detail, focusing on the investigator's brochure, investigational medicinal product (IMP) dossier, circumstances in which a simplified IMPD or Summary of Product Characteristics may be substituted, and other IMP-related data. Online compilation of the application form is explained.

Application for ethics committee favorable opinion
Significant features of an application for EC favorable opinion are discussed in more detail, including the clinical protocol, informed consent form, and subject recruitment materials.

Maintaining authorization
This session deals with the regulatory compliance activities that have to be carried out once a clinical trial has been approved. It examines the procedure for submitting substantial amendments, safety reporting requirements, and declaration of the end of a trial.

The Clinical Trials Regulation
This short session looks forward to the introduction of the Clinical Trials Regulation, which will replace the Clinical Trials Directive and establish greater uniformity in procedures for approval of clinical trials throughout the EEA.

Assessment
Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module?
  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • healthcare professionals conducting clinical research as sponsor-investigators.

It will be of particular value to those who are new to European regulatory affairs, but familiarity with the basics of Good Clinical Practice is assumed.

Learning objectives
  • Outline the legal and regulatory framework that governs clinical trials in the European Economic Area
  • Summarize the procedures that must be carried out to gain approval to proceed with a trial
  • Identify the principal components of an application to a national competent authority for clinical trial authorization and describe their contents
  • Discuss the principal areas of concern to an ethics committee and describe the information to be submitted to one
  • Specify what measures must be taken to maintain the authorization of a trial in progress
  • Identify changes that will be brought about by the Clinical Trials Regulation

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