Regulatory course
Understanding and implementing the EU CTR 536
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.
Dates and booking
Choose your date.
All fees exclude VAT. Booking for several colleagues? Choose the number of participants, or ask about an in-house session.
Who it’s for
Is this course for you?
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.
What you’ll learn
About this course.
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. All stakeholders need to know how to work according to the CTR rules 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 process
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
Programme highlights
Module 1: CTR and CTIS fundamentals
- CTR requirements
- Structure and concepts of the CTIS system
- CTIS Training available
Module 2: Preparing for submission of a clinical trial
- How to register users from sponsors, CROs and investigational sites in CTIS
- Preparing according to the right scenario
Module 3: Submitting the Initial clinical trial application
- Create, compile, and submit an initial clinical trial application
- Respond to requests for information sent by authorities concerned
Module 4: Submissions during an ongoing clinical trial
- 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
References to and screenshots of training materials from the European Medicines Agency are incorporated.
Your trainer
Your trainer.
Format
How the course runs.
In person
In Brussels.
Live online
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Ethical & Participants Safety Considerations1
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
Keep learning