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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Management of Externally Sponsored Studies Course & Certification
Intermediate
4.2
★★★★★
92% Recommended
Updated 2026
2 hour
125 active users
3 points
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About
The Remote and Centralized Monitoring Course is designed to provide a comprehensive understanding of modern clinical trial monitoring approaches that leverage technology, data analytics, and risk-based methodologies. It focuses on improving trial oversight, data quality, and participant safety through efficient remote and centralized monitoring practices.
This course covers key topics including risk-based monitoring strategies, centralized data review, remote source document review, key risk indicators (KRIs), issue identification, and communication with study sites. It also emphasizes Good Clinical Practice (GCP), data integrity, regulatory compliance, and the effective use of technology in clinical trial oversight. Upon completion, learners receive a certification demonstrating competency in remote and centralized monitoring practices.
Who Should Enrol?
- Clinical Research Associates (CRAs)
- Clinical Trial Monitors and Monitoring Leads
- Clinical Operations Professionals
- Clinical Trial Managers and Coordinators
- Risk-Based Monitoring and Quality Management Personnel
- Pharmaceutical, Biotechnology, and CRO Employees
- Clinical Data Management Professionals
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of clinical trial monitoring, including traditional, remote, centralized, and hybrid monitoring approaches within a risk-based quality management framework.
Learn the regulatory expectations, guidelines, and key principles of Risk-Based Monitoring (RBM), including the use of Key Risk Indicators (KRIs), dashboards, and centralized oversight techniques.
Gain knowledge of remote monitoring workflows, data review processes, centralized statistical monitoring, and effective communication with clinical trial sites.
Develop practical skills in utilizing remote monitoring tools, documentation practices, and cross-functional collaboration to support data quality, participant safety, and regulatory compliance.
Course Syllabus
- Proposal structure, key components, title page, table of contents, and effective grant writing fundamental
- Direct and indirect costs, salaries, equipment, supplies, travel, publication costs, and budget justification techniques
- Management plans, roles and responsibilities, collaborations, timelines, and stakeholder coordination
- Award acceptance, PI responsibilities, record-keeping, budget revisions, and project modifications
- IRB requirements, conflicts of interest, informed consent, research integrity, and misconduct prevention
- Pre- and post-award risks, donor requirements, data privacy, and risk mitigation strategies
Our Certified Customers
Learner Rating & Reviews
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536 global ratings
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Frequently Asked Questions
The CyberSecurity Essentials Training Course by Whitehall Training, provides a practical, end-to-end understanding of how to manage externally sponsored studies—from proposal development and budgeting through to award management, ethics, and risk control. Participants will learn how to develop strong funding proposals, justify budgets, manage sponsor relationships, and ensure compliance with regulatory and ethical standards.
By the end of this course, participants will be equipped to develop competitive research proposals, manage sponsor-funded projects effectively, ensure compliance with ethical and regulatory standards, and deliver successful research outcomes across the full project lifecycle.
This course is ideal for individuals who want to begin or advance a career in clinical research, including:
- Aspiring Clinical Research Associates (CRAs)
- Clinical trial site staff transitioning into monitoring roles
- Clinical Research Coordinators (CRCs) seeking career progression
- Professionals working in pharmaceutical, biotech, or CRO environments
- Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
- Industry-aligned training with global recognition
- Fully updated to ICH GCP E6 (R3) requirements
- Apply best practices in data protection and network security
- Practical, scenario-based learning to build real-world confidence
- Certificate issued upon successful completion
