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EU Clinical Trials Regulation 536/2014

EU Clinical Trials Regulation 536/2014

This CTR 536/2014 training course is in English. A certificate of completion will be delivered at the end of the training.
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European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022 and will replace the existing Directive 2001/20/EC at the end of the transition period, on 31 January 2025. It aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

You will be able to complete the course at anytime, anywhere!

This CTR 536/2014 training course applies to all Clinical Research professionals who carry out clinical trials in Europe.

The course applies for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

The programme will highlight the most important of the CTR 536/2014 key requirements and how these have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022.

This will include explaining how the regulation has harmonised procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial CTIS (Clinical Trial Information System).

You will acquire an understanding of:

• The fundamental principles of the CTR 536/2014.
• The content of the clinical trials application dossier.
• The timeline for implementation of the regulation until the currently applicable directive is repealed.
• The coordinated evaluation processes for Part I and Part II.
• The elements that will remain within the area of responsibility of the member states.
• The role of the CTIS (Clinical Trials Information System).
• The new transparency mechanisms for public access to the clinical trials information.
• The changes in safety assessment.
• The clinical trials regulation challenges for the sponsors and how to tackle them.

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Responsible Eliott CHARBONNEAU
Last Update 12/19/2022
Completion Time 1 hour 49 minutes
Members 23
Reg
  • 1 - CTR Overview
    16Lessons ·
    • What changes does the Clinical Trials Regulation bring compared to CTD?
    • Important timelines
    • 8 changes from CTD are essential to understand
    • 1 - Co-ordinated assessments
    • 2 - Centralised electronic database
    • 3 - Increased public transparency
    • 3 - Increased public transparency - continued
    • 4 - New definitions
    • 4 - New definitions- continued
    • 5 - New Timelines
    • 6 - Simplified Safety Reporting
    • 6 - Simplified safety reporting - continued
    • 7 - Improve patient protections for vulnerable subjects
    • 8 - Co-sponsorship
    • Key findings
    • Quiz - 1
      10 xp
  • 2 - Authorization procedure and assessment for a clinical trial
    17Lessons ·
    • The Application dossier
    • The Application dossier - continued
    • Submission of an application
    • Roles and permissions
    • Roles and permissions - continued
    • Roles and permissions - continued
    • Roles and permissions - more information
    • Medicinal Product Registration
    • Selection of the reporting Member State
    • Validation phase
    • Assessment phase
    • Extended assessment
    • Decision on the Clinical Trial
    • Tacit decision on the Clinical Trial
    • Withdrawal or resubmission
    • Key findings
    • Quiz - 2
      10 xp
  • 3 - Authorization procedure for a substantial modification of a clinical trial
    11Lessons ·
    • Definition of a substantial modification
    • Submission of application for a substantial modification
    • Part II substantial modification
    • Multiple substantial modifications
    • Substantial modification in multiple trials
    • Validation a substantial modification (Part 1)
    • Assessment of substantial modification (Part 1)
    • Validation and Assessment of a part 2 substantial modification
    • Decision on the substantial modifications
    • Key findings
    • Quiz - 3
      10 xp
  • 4 - Authorization procedure for the addition of another members state concerned
    3Lessons ·
    • Addition of a Member State
    • Timelines for addition of Member State
    • Key findings
  • 5 - Protection of subjects and informed consent
    3Lessons ·
    • Informed Consent
    • Vulnerable subjects
    • Key findings
  • 6 - Start, end, temporary halt, and early termination of a clinical trial
    3Lessons ·
    • Start, end, temporary halt, and early termination of a clinical trial
    • Key findings
    • Quiz - 6
      10 xp
  • 7 - Safety reporting
    9Lessons ·
    • Reporting of AE and SAE
    • Reporting of SUSARs
    • Unblind the treatment allocation
    • Annual reporting by the sponsor to the Agency
    • Unexpected events
    • Inspection reports
    • Urgent safety measures
    • Key findings
    • Quiz - 7
      10 xp
  • 8 - Conduct of a clinical trial
    11Lessons ·
    • Compliance rules
    • Monitoring
    • Suitability if individuals involved in conducting the clinical triam
    • Traceability, storage, return and destruction of IMP
    • Reporting of serious breaches
    • Investigator's brochure
    • Recording, processing, handling and storage of information
    • Clinical Trial Master File
    • Auxiliary medicinal products
    • Key findings
    • Quiz - 8
      10 xp
  • 9 - Manufacturing and import of investigation medicinal products and auxiliary medicinal products
    4Lessons ·
    • Authorisation of manufacturing and import
    • Responsibilities of the Qualified Person (QP)
    • Key findings
    • Quiz - 9
      10 xp
  • 10 - Labelling
    1Lessons ·
    • Investigational and auxiliary medicinal products
  • 11- Sponsor and investigator
    6Lessons ·
    • Sponsor and co-sponsorship
    • Sponsor and co-sponsorship
    • Principal investigator
    • Legal representative of the sponsor in the Union
    • Key findings
    • Quiz - 11
      10 xp
  • 12 - Damage compensation
    1Lessons ·
    • Damage compensation
  • Conclusion
    7Lessons ·
    • Let's recapitulate !
    • Challenge 1 - Reporting Member State
    • Challenge 2 - Identifying user roles in CTIS
    • Challenge 3 - Increased public transparency
    • Challenge 4 - Safety reporting
    • Challenge 5 - Transition strategy
    • It’s time for the final exam!
  • Final Certification
    1Lessons ·
    • EU CTR 536/2014 - Certification

Authors of the training

Christoph Wachter


Head of Clinical Operations at ExperTrials, Christoph holds a PhD in Biochemistry and has 30 years of professional experience in Clinical Research.

Know more about him

Aurélie Weiss-Guimet

 
CEO of ExperTrials, Aurélie holds a Master of Science in Project Management and Clinical Operations and has 15 years’ experience in Clinical Research.

Know more about her