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Klinik Araştırma
Klinik Araştırma
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📜 Sertifika (24 ay)
Clinical Research Associate (CRA) Certification Program — English
Comprehensive CRA training covering monitoring, SDV, RBQM, site management, and ACRP-CCRA/SOCRA-CCRP exam preparation. Based on ICH E6(R3), FDA Risk-Based Monitoring.
👤 Hedef Kitle
Nurses, pharmacists, biologists, health professionals seeking CRA career
⏱️ Süre
11 saat 40 dk
📋 İçerik
10 modül
🎯 Öğrenme Çıktıları
10 hedef
🎯 Bu Eğitimde Ne Öğreneceksiniz?
✓
Understand CRA role, responsibilities, and career path
✓
Apply clinical trial science and study design principles
✓
Implement ethical standards and regulatory requirements
✓
Conduct site visits (PSV, SIV, IMV, COV) professionally
✓
Apply risk-based monitoring (RBQM) per ICH E6(R3)
✓
Perform SDV and ensure ALCOA+ data quality
✓
Manage IP accountability and safety reporting
✓
Handle deviations, CAPA, and site escalation
✓
Write professional monitoring reports and follow-up letters
✓
Prepare for ACRP-CCRA and SOCRA-CCRP certification exams
Bu programın tamamına erişin
10 modül, sınav ve e-imzalı sertifika dahil.
1
Modül 1
Zorunlu 60 dk
Module 1: CRA Role, Career Path, and Industry
2
Modül 2
Zorunlu 60 dk
Module 2: Clinical Trial Science and Study Design
3
Modül 3
Zorunlu 90 dk
Module 3: Ethics, Participant Safety, and Regulatory Framework
4
Modül 4
Zorunlu 90 dk
Module 4: Site Visits — PSV, SIV, IMV, COV
5
Modül 5
Zorunlu 90 dk
Module 5: Risk-Based Monitoring (RBQM)
6
Modül 6
Zorunlu 60 dk
Module 6: SDV, Data Quality, and ALCOA+
7
Modül 7
Zorunlu 60 dk
Module 7: IP Management, Safety Reporting, and AE/SAE
8
Modül 8
Zorunlu 60 dk
Module 8: Deviation, CAPA, and Site Issue Management
9
Modül 9
Zorunlu 60 dk
Module 9: Monitoring Reports and Professional Communication
10
Modül 10
Zorunlu 70 dk
Module 10: ACRP CCRA / SOCRA CCRP Exam Preparation
📝 Sınavlar
CRA Final Certification Exam (EN)
39 soru