(1 customer review)

Expert ECTR Course for Clinical Drug Trials in Europe

This course was previously called “ECTR Expert”. Learn everything you need to know to master the upcoming European Clinical Trial Regulation applicable to clinical trials conducted in Europe. Includes 4 interactive modules, 1 test and takes 7.5 hours to complete.

 95.00

Additional information

Accreditation

,

Job Role

, , , ,

Language

,

Level

Phase of Study

, , , , , , ,

Region of Regulation

Regulation

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.

Category: Tag:

LEARNING OBJECTIVES

  • Principles of ECTR (EU Clinical Trial Regulation)
  • Critical timelines for submission and review of a dossier
  • Transition period and expected implementation ECTR
  • Submission strategies
  • Contents of submission dossier Part I and II
  • Preparing and submitting the research dossier in the CTIS portal
  • Role of the submitter, the reviewer, and the investigator
  • Submission and review requirements and use of CTIS portal
  • Deadlines and planning of the medical-ethical review
  • How to answer questions from the reviewing ethics committee
  • Requirements for the conduct of clinical drug research
  • Safety reporting requirements
  • Submitting substantial amendments via the CTIS
  • How to avoid breaches and quality issues and what to do if they happen
  • End of trial reporting, a summary of Clinical Trial Results for Laypersons
  • Publication of trial data: requirements and transparency

 

DESCRIPTION

ECTR stands for European Clinical Trial Regulation. This is the new EU regulation on clinical trials of medicinal products for human use which replaces the existing Directive 2001/20/EC. The ECTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved.

The expert ECTR course for clinical trials in Europe helps you understand all the vital aspects of the ECTR regulation. You’ll learn all strategic elements, from study design to submission, and from approval to conduct. Completion of this course will make you the ECTR expert and be fully prepared for its implementation in 2021.

  • 7,5 hours
  • 4 modules
  • Online ECTR certificate
  • Knowledge Test
  • Available on desktop, smartphone or tablet

The Expert ECTR course is intended for anyone who is responsible for product development and management, drug research design, and/ or strategic decisions. This course is perfect for research and science coordinators, principal investigators (investigator-initiated research), sponsors, medical directors, head of ClinOps, study directors, project managers, CRAs, monitors, and people responsible for submitting dossiers

The online course takes 7.5 hours and consists of the basic ECTR module, the preparation module, the submission module, the conduct module, and a knowledge test. After completion, you will receive an online ECTR certificate.

 

COURSE CONTENTS

Module 1: Introduction
Module 2: Prepare submission dossier
Module 3: Submission and review
Module 4: During the study

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.

1 review for Expert ECTR Course for Clinical Drug Trials in Europe

  1. Published

    I found it an interesting course. Very good layout and interactive with questions, tables, and short films. When the EU-portal will be available it is good to have already a basic knowledge. It will of course become clearer after some practice in the portal itself.

Add a review

Do you know someone who would like this course? Tell them about it…