Global Certificate in Clinical Trial Governance Fundamentals
-- ViewingNowThe Global Certificate in Clinical Trial Governance Fundamentals is a comprehensive course designed to empower learners with the essential skills required in the clinical trials industry. This program highlights the importance of good governance, risk management, and ethical considerations in clinical trials, making it highly relevant and sought-after by employers worldwide.
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โข Clinical Trial Basics: Understanding Clinical Research, ICH-GCP Guidelines, Clinical Trial Phases
โข Ethical Considerations: Informed Consent, Privacy & Confidentiality, Ethical Review Boards
โข Study Design & Protocol Development: Types of Studies, Endpoints, Statistical Considerations
โข Site Selection & Management: Feasibility, Site Initiation, Monitoring & Closeout
โข Investigational Product Management: IMP Supplies, Storage, Distribution & Accountability
โข Data Management: CRF Design, Data Entry, Validation & Cleaning
โข Clinical Trial Safety: Safety Reporting, Adverse Event Management, SAE Follow-up
โข Quality Management & Auditing: QMS Principles, Audit Preparation, Findings Management
โข Clinical Trial Budgeting & Contracting: Cost Structures, Budget Negotiations, Contractual Agreements
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