Advanced Certificate in Clinical Trial Site Monitoring
-- viewing nowThe Advanced Certificate in Clinical Trial Site Monitoring is a comprehensive program designed to equip learners with the essential skills required for a successful career in clinical research. This course highlights the importance of monitoring clinical trials, ensuring data integrity, and adhering to regulatory compliance.
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Course Details
• Introduction to Clinical Trial Site Monitoring: Regulations, ICH-GCP guidelines, monitoring objectives, types of monitoring
• Site Selection and Initiation: Protocol feasibility, site qualification, essential documents, pre-study visits
• Data Management in Clinical Trials: CRF design, data entry, data validation, data queries, database lock
• Source Document Verification: SDV objectives, risk-based monitoring, remote SDV
• Regulatory Compliance and Audit Preparation: FDA, EMA regulations, SOPs, internal/external audits, QMS
• Adverse Event Management: Safety reporting, SAEs, suspected unexpected serious adverse reactions (SUSARs)
• Monitoring Visit Planning and Execution: Visit preparation, data review, regulatory binder review, close-out visits
• Advanced Monitoring Techniques: Centralized monitoring, remote monitoring, statistical monitoring
• Quality Control and Quality Assurance: QC vs QA, quality metrics, quality improvement plans, CAPA
Career Path
Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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