Lessons
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EU Clinical Trials Regulation 536/2014
    • 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
    • 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
    • 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
    • Addition of a Member State
    • Timelines for addition of Member State
    • Key findings
    • Informed Consent
    • Vulnerable subjects
    • Key findings
    • Start, end, temporary halt, and early termination of a clinical trial
    • Key findings
    • Quiz - 6
    • 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
    • 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
    • Authorisation of manufacturing and import
    • Responsibilities of the Qualified Person (QP)
    • Key findings
    • Quiz - 9
    • Investigational and auxiliary medicinal products
    • Sponsor and co-sponsorship
    • Sponsor and co-sponsorship
    • Principal investigator
    • Legal representative of the sponsor in the Union
    • Key findings
    • Quiz - 11
    • Damage compensation
    • 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!
    • EU CTR 536/2014 - Certification