- 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
- Safety reporting requirements
- Submitting substantial amendments via the CTIS
- How to avoid breaches and quality issues and what to do if they happen
- End of trial reporting, a summary of Clinical Trial Results for Laypersons
- Publication of trial data: requirements and transparency
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 Conduct course to conduct clinical trials in Europe gives you the essentials on the upcoming EU CTR, as well as everything you need to know about the EU CTR’s requirements during the clinical conduct of the study: optimization of collaborations, substantial amendments, safety, and trial reporting, preventing serious breaches, and quality control. It will prepare you for its implementation in 2021.
- 3.5 hours
- 2 modules
- Online EU CTR certificate
- incl. Knowledge test
- Available on desktop, smartphone or tablet
It is an ideal introductory course suitable for anyone involved in the implementation of clinical drug research. The course offers a complete insight into what the new regulation means for conducting clinical drug research and is most suitable for research nurses and medical doctors.
The online course takes 3.5 hours and consists of the basic EU CTR module, the conduct 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.
- 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
- Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
Module: During the study
- Process steps, communication, and the result of the submission and assessment of a substantial amendment (part I or part II)
- Definition and examples of substantial amendments and submission of substantial amendment
- Terms and conditions for the request of the assessment of a substantial amendment
- Explanation when a submission is a ‘mixed’ submission
- Requirements for reporting of AEs and SAEs to the sponsor; when deviations from the standard are allowed and how this should be documented
- When is it required to set up a DSMB?
- Requirements for expedited reporting of SUSARs
- Definition, examples, and procedures in case of a serious breach
- Process steps, communication, and the result of the end of the study, suspension of a trial, premature termination
- Requirements for final reports, publication, and disclosure of scientific summary and lay summary via the CTIS
- Importance of transparency and documentation of trial results
- Eudravigilance database for reported unblinded SUSAR and yearly safety report
- Retention periods for trial-specific documentation
Module: Knowledge test
- 20 questions
- Available in English and Dutch
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher