Global Certificate in Clinical Trials: Strategic Approaches
-- ViewingNowThe Global Certificate in Clinical Trials: Strategic Approaches is a comprehensive course designed to provide learners with critical skills in clinical trial strategy and management. This certification is essential in an industry where the demand for experienced clinical trials professionals continues to grow.
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โข Clinical Trials Overview: Understanding Clinical Research, Phases of Clinical Trials, Importance of Clinical Trial Design
โข Global Regulatory Landscape: FDA, EMA, ICH, and Other Regulatory Bodies, Harmonization Efforts, Global Clinical Trial Regulations
โข Study Design and Protocol Development: Types of Study Designs, Writing a Clinical Trial Protocol, Statistical Considerations
โข Site Selection and Management: Identifying Suitable Clinical Trial Sites, Site Initiation, Feasibility, and Monitoring
โข Patient Recruitment and Retention: Strategies for Recruiting and Retaining Patients, Informed Consent, Cultural Considerations
โข Data Management and Quality Assurance: Data Collection, Management, and Reporting, Quality Assurance and Control Measures
โข Pharmacovigilance and Safety Monitoring: Adverse Event Reporting, Pharmacovigilance Systems, Safety Monitoring Plans
โข Ethics and Human Subject Protection: Ethical Principles in Clinical Research, Institutional Review Boards, Informed Consent
โข Global Collaboration and Partnerships: Building and Managing Global Clinical Trial Teams, International Collaboration Best Practices
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