Modul EW4250-KP06

Workload:

• 60 Hours in-classroom work
• 90 Hours private studies

Contents of teaching:

• GCP- Basic course: Curriculum Requirements for GCP Basic Course Certification
• Ethical and methodological foundations: • Relevant regulatory and ethical frameworks (Declaration of Helsinki, Declaration of Taipei, Nuremberg Code, etc.) • Ethical principles of clinical research (relationship between ethics and law, protection of vulnerable populations, etc.) • Objectives of medicinal product development and clinical testing • Phases of drug development (Phases I–IV) • Types of clinical studies and study designs • Biostatistical fundamentals / ICH E9 • Study phases and study types: fundamental regulatory framework including the German Medicinal Products Act (AMG), Medical Devices Law Implementation Act (MPDG), and In Vitro Diagnostic Regulation (IVDR)- overview
• Legal foundations: • EU law and national (German) legislation (Regulation (EU) No 536/2014; German Medicinal Products Act (AMG); Radiation Protection Act (StrlSchG) and Radiation Protection Ordinance (StrlSchV); General Data Protection Regulation (GDPR); Medical Devices Law Implementation Act (MPDG); In Vitro Diagnostic Regulation (IVDR); German Medical Research Act (MFG)) • Guidelines and principles of Good Clinical Practice (ICH-GCP), including the structure of ICH-GCP E6 (R3); key words: Quality by design, fit for purpose, critical to quality factors, risk based approach
• Informed Consent, Monitoring, audits, and inspections: • Ability to give informed consent; special aspects for minors and patients unable to consent • Informed consent and documents • Monitoring, audits, and inspections
• Routine Study Conduct • Screening and inclusion/exclusion criteria • Protocol-compliant treatment, treatment alternatives, and discontinuation criteria • Handling of investigational products • Protocol deviations • Subsequent amendments • Documentation (e.g., CRFs, queries, archiving)
• Adverse Events and safety
• Submission and Study Preparation: • Regulatory submissions via centralized digital platforms • Use of EthicsPool as an ethics review and coordination tool • Clinical trial submissions and management through the Clinical Trials Information System (CTIS)
• Quality Management: • Case examples (e.g. fictitious patient records) and identification and listing of relevant cases (from audits and inspections) • Data protection and confidentiality • Investigator Site File (ISF) and Trial Master File (TMF)
• Roles and Perspectives in Clinical Trials: • Collaboration • Compliance • Project Management in Clinical Trials
• Case report Form (CRF) • Differences between paper-based CRFs and electronic CRFs (eCRFs) • What a clinical trial database is and its role in data management • Key considerations when entering and managing data o Accuracy and completeness o Using dropdown menus, checklists, and standardized options o Avoiding common errors and inconsistencies
• External Funding and Finances • Funding • Challenges • Things Often Forgotten in Clinical Trials
• Planning of a clinical trial and funding, study Planning What needs to be done in the planning phase of a clinical trial at the UKSH? • Third-party funding and funding allocation (who pays for what) • Understanding the type and scope of the study • Initial consultation and study feasibility assessment • Coordination and agreements with for example the sponsor, biostatisticians (BI) and Data Management (DM) teams • Patient involvement, patient recruitement
• Differences Between Foods, Dietary Supplements, and Investigational Products • Distinction between regular foods and dietary supplements • Regulatory and scientific boundary between supplements and investigational products and classification of probiotics • Implications for clinical studies and product testing