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
- 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
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 fundamental online EU CTR Submission course to prepare and submit clinical trials in Europe gives you the essentials on the upcoming EU CTR, as well as an understanding of how to develop submission dossiers in line with the upcoming EU CTR 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 EU CTR 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 EU CTR module, the preparation 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
- 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 CTR and 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
- Are there differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
Module: Prepare submission dossier
- Scope of EU CTR and international differences
- Prepare an application dossier compliant to the EU CTR 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
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
- 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
- Requirements for the start-up of an approved clinical trial
Module: Knowledge test
- 30 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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