Global Certificate in Clinical Trial Governance Fundamentals

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The 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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AboutThisCourse

In today's rapidly evolving healthcare landscape, there is an increasing demand for professionals who can ensure the successful planning, execution, and monitoring of clinical trials. This course equips learners with the necessary knowledge and tools to meet industry standards and regulations, reducing compliance risks and ensuring the safety and well-being of trial participants. By completing this course, learners will gain a competitive edge in their careers, demonstrating their expertise in clinical trial governance and their commitment to ethical and responsible research practices. This certification is a valuable asset for professionals in various roles, including clinical research associates, project managers, and regulatory affairs specialists, among others.

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CourseDetails

• 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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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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FastTrack GBP £149
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
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StandardMode GBP £99
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FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • FullCourseAccess
  • DigitalCertificate
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GLOBAL CERTIFICATE IN CLINICAL TRIAL GOVERNANCE FUNDAMENTALS
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UK School of Management (UKSM)
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05 May 2025
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