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Klinik Araştırma
Klinik Araştırma
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📜 Sertifika (24 ay)
Clinical Research Monitor (CRA) Training Program — English
12-module CRA/Monitor training: site visits, SDV, RBQM, IP, safety, CAPA, reports, inspection prep. Based on ICH E6(R3), FDA RBM, ACRP CCRA.
👤 Hedef Kitle
Nurses, pharmacists, biologists, health professionals seeking CRA/Monitor career
⏱️ Süre
10 saat
📋 İçerik
12 modül
🎯 Öğrenme Çıktıları
11 hedef
🎯 Bu Eğitimde Ne Öğreneceksiniz?
✓
Understand CRA role and career path
✓
Read protocols and identify critical data
✓
Apply ethics and regulations
✓
Conduct PSV/SIV/IMV/COV visits
✓
Apply risk-based monitoring
✓
Perform SDV and ensure ALCOA+
✓
Manage IP and safety reporting
✓
Handle deviations and CAPA
✓
Manage site escalation
✓
Write monitoring reports
✓
Prepare for FDA/TITCK inspections
Bu programın tamamına erişin
12 modül, sınav ve e-imzalı sertifika dahil.
1
Modül 1
Zorunlu 50 dk
Module 1: CRA Role, Career Path, and Industry
2
Modül 2
Zorunlu 50 dk
Module 2: Clinical Trial Science and Protocol Reading
3
Modül 3
Zorunlu 60 dk
Module 3: Ethics, Participant Protection, and Regulations
4
Modül 4
Zorunlu 50 dk
Module 4: Site Visits — PSV and SIV
5
Modül 5
Zorunlu 50 dk
Module 5: Site Visits — IMV and COV
6
Modül 6
Zorunlu 50 dk
Module 6: Risk-Based Monitoring (RBQM)
7
Modül 7
Zorunlu 50 dk
Module 7: SDV, Data Quality, and ALCOA+
8
Modül 8
Zorunlu 50 dk
Module 8: IP Management and Safety Reporting
9
Modül 9
Zorunlu 50 dk
Module 9: Protocol Deviations and CAPA
10
Modül 10
Zorunlu 50 dk
Module 10: Site Issue Management and Escalation
11
Modül 11
Zorunlu 50 dk
Module 11: Monitoring Reports and Professional Communication
12
Modül 12
Zorunlu 50 dk
Module 12: Inspection Preparation and Certification
📝 Sınavlar
CRA Monitor Final Exam (EN)
20 soru