EU CTR Foundation

Our Introductory EU CTR Foundation e-learning course teaches you the essentials of the European Clinical Trial Regulation. Includes 1 interactive module, 1 test and takes 1.5 hours to complete.

Are you involved in clinical research in the Netherlands? Click here

€ 50.00

Additional information

Accreditation	GAIA, V&VN RZ, VSR
Job Role	All, Clinical Trial Site Staff, Investigator, Monitor/CRA, Pharmacist, Pharmacy Assistant, Project Manager, Research Coordinator, Research Nurse, Sponsor/CRO Staff, Student
Language	Dutch, English
Level	Introductory
Phase of Study	Foundation
Region of Regulation	Europe
Regulation	EU CTR

Need more than 5 licenses?

Connect with our corporate team to discuss your organization’s learning needs and discover how our training solutions can help transform your business.

MYGCP FOR BUSINESS

Category: Online Tag: EU CTR

LEARNING OBJECTIVES

Principles of EU CTR (EU Clinical Trial Regulation)
Critical timelines for submission and review of a dossier
Transition period and expected implementation
Impact on the conduct of a clinical drug trial in Europe

DESCRIPTION

EU CTR stands for European Clinical Trial Regulation. The EU CTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved. The EU CTR Foundation course for clinical trials in Europe explains the principles of the regulation, clarifies the critical timelines, helps you understand the changes, and be EU CTR ready.

1.5 hours
1 Learning Module
Online EU CTR certificate
Knowledge Test
Available on desktop, smartphone, or tablet
Accreditation pending

It is an ideal introductory course suitable for anyone (clinical and non-clinical) involved or interested in medical science and drug research. The course enables you to get a good overview of the regulations and the consequences of the implementation of clinical drug research. It is perfect for: doctors, research nurses, patients, students (medicine or biology), clinical trial assistants, employees of CROs, employees of (hospital) pharmacies. The online course takes 1.5 hours and consists of the basic EU CTR module and a knowledge test. After completion, you will receive an online EU CTR certificate.

COURSE CONTENTS

Module: Introduction

You’ll learn the following in this module:

Goal EU CTR and difference between a Directive and Regulation
Scope of EU CTR: to which type of research is the EU CTR applicable?
High-level contents of the EU CTR
Opportunities, benefits, and challenges of the EU CTRand submissions via the CTIS portal
When will the EU CTR be implemented and what does the transition period look like?
Timelines of the submission- and review process according to the EU CTR regulation
Differences in the submission of a national trial and an international trial
Results of the validation phase, Assessment part I and assessment part II
Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials

Module: Knowledge test

The knowledge test includes:

10 questions
Available in English and Dutch
Feedback per question (afterwards)
3 attempts
Online certificate with a score of 80 or higher

Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks. We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

Reviews

Be the first to review “EU CTR Foundation”

You must be logged in to post a review.

EU CTR Foundation

Additional information

Need more than 5 licenses?

LEARNING OBJECTIVES

DESCRIPTION