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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⢠Clinical Trial Basics: Understanding Clinical Research, ICH-GCP Guidelines, Clinical Trial Phases
⢠Ethical Considerations: Informed Consent, Privacy & Confidentiality, Ethical Review Boards
⢠Study Design & Protocol Development: Types of Studies, Endpoints, Statistical Considerations
⢠Site Selection & Management: Feasibility, Site Initiation, Monitoring & Closeout
⢠Investigational Product Management: IMP Supplies, Storage, Distribution & Accountability
⢠Data Management: CRF Design, Data Entry, Validation & Cleaning
⢠Clinical Trial Safety: Safety Reporting, Adverse Event Management, SAE Follow-up
⢠Quality Management & Auditing: QMS Principles, Audit Preparation, Findings Management
⢠Clinical Trial Budgeting & Contracting: Cost Structures, Budget Negotiations, Contractual Agreements
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