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 drug trials in the Netherlands 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
- accredited by several quality registers
- 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 in the Netherlands, 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
Module 1: 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?
- Dutch ambition regarding the introduction of the ECTR
- 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
- Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
Module 2: 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
Module 3: 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
Published –
I enjoyed this masterclass a lot and feel energized to use what in learning on the job.