Understanding and complying with the EU CTR
About this course
Reasons to attend
The aim of this course is to provide an overview of the EU CTR 536/2014 (CTR) and to allow participants to implement it in their organisation.It will allow participants to understand how the Clinical Trials Information System (CTIS) is set up, in 4 modules.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions of 3h each |
Course Description
The European Clinical Trial Regulation (CTR) 536/2014 is the legislation that harmonises regulatory processes and information of interventional clinical trials in Europe.To meet CTR requirements, entries in the European Clinical Trials Information System (CTIS) are mandatory. Once the CTIS is launched (planned for 31 January 2022), it will be operational and the implementation of the CTR can start. All stakeholders need to know how to work according to the new rules (CTR) and use the CTIS.This course aims to provide an overview of mandatory CTR requirements and allow participants ready to implement them and be compliant with them.Note: This course is not intended to go into detail about the technical aspects of the CTIS, though it will provide references where to find resources on this topic. *This course is not a CTIS training as ECCRT does not have access to CTIS and cannot replicate the CTA processProgramme highlight
Module 1: CTR and CTIS fundamentals
- CTR requirements
- Structure and concepts of the CTIS system
- CTIS Training available
- How to register users from sponsors, CROs and investigational sites in CTIS
- Preparing according to the right scenario
- Create, compile, and submit an initial clinical trial application
- Respond to requests for information sent by authorities concerned
- Notifications related to the recruitment of patients or unexpected safety events
- Updating a trial application, substantial modifications and adding a Member State
- Submitting trial results
Learning objectives
- Understand the Clinical Trial Regulation 536/2914 and be compliant with it
- Understand the structure of the CTIS and know where to find resources on how to use it
- Be able to Implement roles of the administrator, creator, reviewer and submitter
- Know how to prepare and submit a research dossier
- Understand what needs to be submitted during an ongoing clinical trial and how to do this
- Know how to notify the end of the trial and to submit the summary of trial results for laypersons
Who should attend
This course is developed for anyone who needs to understand the Clinical Trial Regulation and needs to be compliant with it.
The focus will be on sponsors of clinical trials from academia as well as from the pharmaceutical industry. In particular medical directors, heads of Clinical Operations, sponsor-investigators, study directors, contract research organisation (CRO) staff, project managers, regulatory affairs staff, research coordinators, CRAs, monitors, and all persons responsible for submitting clinical trial dossiers should attend this course.Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Christian Riegel
Idorsia Pharmaceuticals
Edith Van Dijkman
Santen