- Principles of EU CTR (EU Clinical Trial Regulation)
- Critical timelines for submission and review of a dossier
- Transition period and expected implementation
- Impact on the conduct of a clinical drug trial in Europe
- Understand the changes and be prepared for its implementation in 2021
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 Foundation course for clinical trials in Europe explains the principles of the new regulation, clarifies the critical timelines, helps you understand the changes, and be prepared for its implementation in 2021. Be EU CTR ready.
- 1.5 hours
- 1 Learning Module
- Online EU CTR certificate
- Knowledge Test
- Available on desktop, smartphone, or tablet
- Accreditation pending
It is an ideal introductory course suitable for anyone (clinical and non-clinical) involved or interested in medical science and drug research. The course enables you to get a good overview of the new regulations and the consequences of the implementation of clinical drug research. It is perfect for: doctors, research nurses, patients, students (medicine or biology), clinical trial assistants, employees of CROs, employees of (hospital) pharmacies. The online course takes 1.5 hours and consists of the basic EU CTR module and a knowledge test. After completion, you will receive an online EU CTR certificate.
[toggles title=”Module: Introduction”] You’ll learn the following in this module:
- 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 CTRand 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
- Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
[toggles title=”Module: Knowledge test”]
The knowledge test includes:
- 10 questions
- Available in English and Dutch
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher