LEARNING OBJECTIVES
- Principles of EU CTR (EU Clinical Trial Regulation)
- Critical timelines for submission and review of a dossier
- Transition period and expected implementation
- EU CTR (EU Clinical Trial Regulation)
- Role of the reviewer, collaboration with other member states and submitters
- Review requirements and use of CTIS portal
- Deadlines and planning of the medical-ethical review
- How to address questions at the submitter of the dossiers
DESCRIPTION
EU CTR 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 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 Reviewers in the Netherlands not only helps you understand the upcoming EU CTR regulation but offers a clear and in-depth understanding of the critical roles, deadlines, and planning of the new procedures for the medical-ethical review of a drug trial according to the new EU legislation. It will prepare you for its implementation in 2021.
- 3 hours
- 2 modules
- Online EU CTR certificate
- incl. Knowledge test
- Accredited by several quality registers
- Available on desktop, smartphone or tablet
It is an ideal course suitable for anyone involved in ethics committees or responsible for reviewing submitted clinical research dossiers. The course provides a detailed understanding of the EU CTR and its implications for the assessment process and is most suitable for employees of the CCMO and members of the Dutch ethics committees.
The online course takes 3 hours and consists of the basic EU CTR module, the submission module and a knowledge test. After completion, you will receive an online EU CTR certificate.
Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
Module: Introduction
- The goal and high-level contents of the EU CTR
- Scope of the EU CTR: to which type of research the EU CTR is applicable
- Dutch ambition regarding the introduction of the EU CTR
- Opportunities, benefits, and challenges of the EU CTR and submissions via the EU-portal (CTIS)
- Information about the transitional period from CTD to EU CTR
- 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
Module: Submission and review
- 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 (rMS)
- 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 EU CTR
- 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
Module: Knowledge test
- 20 questions
- Available in English and Dutch
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher
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