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Fundamental ECTR Course to Submit Clinical Drug Trials in Europe

This course was previously called “ECTR Submission”. Our Fundamental ECTR e-learning course gives you the essentials on the upcoming European Clinical Trial Regulation and everything you need to know to submit research data and information via the EU Portal (CTIS). Includes 3 interactive modules, 1 test, and takes 5 hours to complete.

 80.00

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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 member states
  • 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

 

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 fundamental online ECTR course to prepare and submit clinical trials in Europe gives you the essentials on the upcoming ECTR, as well as an understanding of how to develop submission dossiers in line with the upcoming ECTR regulation. Bring your strategies, roles, dossier contents, patient information, and study feasibility in line with the new regulation. It will prepare you for its implementation in 2021.

  • 5 hours
  • 3 modules
  • Online ECTR certificate
  • incl. Knowledge Test
  • Available on desktop, smartphone or tablet

It is an ideal fundamental course suitable for anyone involved in the preparation, development, and submission of clinical drug trial submission packages, most suitable for start-up groups, CROs, and research coordinators.

The online course takes 5 hours and consists of the basic ECTR module, the preparation module, the submission module, and a knowledge test. After completion, you will receive an online ECTR certificate.

Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.

 

COURSE CONTENTS

[toggles title=”Module:  Introduction”]
You’ll learn the following in this module:

  • Goal ECTR and difference between a Directive and Regulation
  • Scope of ECTR: to which type of research is the ECTR applicable?
  • High-level contents of the ECTR
  • Opportunities, benefits, and challenges of the ECTR and submissions via the CTIS portal
  • When will the ECTR be implemented and what does the transition period look like?
  • Timelines of the submission- and review process according to the ECTR 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
  • Are there differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials

[/toggles]

[toggles title=”Module: Prepare submission dossier”]
You’ll learn the following in this module:

  • Scope of ECTR and international differences
  • Prepare an application dossier compliant to the ECTR requirements
  • Roles and responsibilities in the preparation of submission, including a legal representative
  • Pro’s and con’s of various submission strategies
  • Functionalities of the EU-portal (CTIS)
  • Contents of application dossier part I and part II, incl protocol, CTA, pediatric research plan
  • Definition and criteria for the use and documentation of auxiliary medicinal product (AxMP)
  • Requirements to the application dossier in case of research with incapacitated persons, clinical research in emergency situations, or research including pregnant or breastfeeding women
  • Requirements to the production and labeling of IMP’s
  • Requirements for insurance

[/toggles]

[toggles title=”Module: Submission and review”]
You’ll learn the following in this module:

  • Process steps, communication, and the result of the validation process of Part I (national) and Part II (multinational)
  • Submission process via the EU-portal (CTIS)
  • Determination process which member state takes the role of Reporting Member State
  • Considerations for answering questions during the review process and adjustments to the application dossier
  • Composition review committee
  • Review whether the clinical trial is included in the scope of the ECTR
  • Review of completeness and acceptability of the clinical trial and application dossier
  • Consolidated and coordinated review
  • Getting to a conclusion and the requirements to the assessment report
  • Requirements for the start-up of an approved clinical trial

[/toggles]

[toggles title=”Module: Knowledge Test”]
The knowledge test includes:

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

[/toggles]

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 Fundamental ECTR Course to Submit Clinical Drug Trials in Europe

  1. matyas@igina.net

    I highly recommend this course for everyone

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