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Klinik Araştırma
Klinik Araştırma
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📜 Sertifika (24 ay)
Good Clinical Practice (GCP) E6(R3) Training — ICH-Based
ICH E6(R3) GCP training based on TransCelerate Minimum Criteria v3.0. 16 modules, 25 hours. For investigators and site personnel.
👤 Hedef Kitle
Principal Investigator (PI), Sub-Investigator, Study Nurse, Clinical Research Coordinator (CRC), Pharmacist, Delegated Site Personnel
⏱️ Süre
25 saat
📋 İçerik
6 modül
🎯 Öğrenme Çıktıları
8 hedef
🎯 Bu Eğitimde Ne Öğreneceksiniz?
✓
Explain the definition, purpose, and ethical foundation of ICH E6(R3) GCP
✓
Apply the 42 ICH GCP principles organized in 11 categories
✓
Implement investigator responsibilities and delegation management
✓
Manage the informed consent process in all its aspects
✓
Apply AE/SAE/SUSAR safety reporting chains flawlessly
✓
Apply ALCOA+ data integrity principles
✓
Explain data governance and computerized system compliance
✓
Meet TransCelerate mutual recognition minimum criteria
Bu programın tamamına erişin
6 modül, sınav ve e-imzalı sertifika dahil.
1
Modül 1
Zorunlu 45 dk
Module 1: GCP Overview and Basic Definitions
2
Modül 2
Zorunlu 45 dk
Module 4: Investigator — Qualifications, Resources, and Responsibilities
3
Modül 3
Zorunlu 45 dk
Module 8: Participant Medical Care and Safety Reporting
4
Modül 4
Zorunlu 45 dk
Module 11: Investigational Product (IP) Management
5
Modül 5
Zorunlu 45 dk
Module 13: Records, Source Data, and Reporting (ALCOA+)
6
Modül 6
Zorunlu 45 dk
GCP Case Studies and Practical Scenarios
📝 Sınavlar
GCP E6(R3) Comprehensive Certification Exam (EN)
50 soru