Certificate in Clinical Trial Governance Fundamentals
-- ViewingNowThe Certificate in Clinical Trial Governance Fundamentals is a comprehensive course that equips learners with critical skills for success in the clinical trials industry. This program focuses on essential governance aspects, ensuring that clinical trials are conducted ethically and efficiently.
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GBP £ 149
GBP £ 215
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• Clinical Trial Basics – Understanding the fundamentals of clinical trials, including their purpose, phases, and key stakeholders.
• Ethical Considerations – Exploring the ethical principles that guide clinical trial conduct, such as informed consent, patient safety, and data privacy.
• Regulatory Landscape – Examining the regulatory frameworks that govern clinical trials, including FDA regulations, ICH guidelines, and EU directives.
• Good Clinical Practice (GCP) – Learning the international standards for clinical trial conduct, including GCP principles, informed consent, and data management.
• Clinical Trial Protocols – Understanding the structure and components of clinical trial protocols, including study objectives, inclusion/exclusion criteria, and study procedures.
• Data Management – Exploring the principles of clinical trial data management, including data collection, validation, and reporting.
• Safety Monitoring – Examining the safety monitoring processes in clinical trials, including adverse event reporting and safety data analysis.
• Quality Assurance – Learning the principles of quality assurance in clinical trials, including audits, inspections, and corrective action plans.
• Clinical Trial Management – Understanding the key elements of clinical trial management, including project planning, budgeting, and vendor management.
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