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Mastering Clinical Trial Management; A Step-by-Step Guide to Ensuring Compliance and Mitigating Risk

Mastering Clinical Trial Management; A Step-by-Step Guide to Ensuring Compliance and Mitigating Risk

$199.00
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Mastering Clinical Trial Management: A Step-by-Step Guide to Ensuring Compliance and Mitigating Risk



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of clinical trial management, including the principles, regulations, and best practices for ensuring compliance and mitigating risk. Participants will receive a certificate upon completion, issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and personalized course content
  • Up-to-date information on the latest regulations and industry trends
  • Practical, real-world applications and case studies
  • High-quality content developed by expert instructors
  • Certificate of Completion issued by The Art of Service
  • Flexible learning options, including online access and mobile accessibility
  • User-friendly interface and community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access to course materials
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to Clinical Trial Management

  • Defining clinical trial management and its importance
  • Overview of the clinical trial process
  • Key players and roles in clinical trial management
  • Regulatory framework and guidelines

Module 2: Clinical Trial Design and Planning

  • Principles of clinical trial design
  • Types of clinical trials (Phase I-IV)
  • Clinical trial protocol development
  • Sample size calculation and statistical analysis

Module 3: Clinical Trial Conduct and Monitoring

  • Site selection and initiation
  • Patient recruitment and retention
  • Data collection and management
  • Clinical trial monitoring and auditing

Module 4: Clinical Trial Safety and Pharmacovigilance

  • Principles of pharmacovigilance
  • Adverse event reporting and management
  • Serious adverse event (SAE) reporting and management
  • Safety monitoring and risk management

Module 5: Clinical Trial Quality and Compliance

  • Quality management in clinical trials
  • Regulatory compliance and inspections
  • Clinical trial auditing and CAPA
  • Quality metrics and performance indicators

Module 6: Clinical Trial Data Management and Analysis

  • Data management principles and best practices
  • Data validation and verification
  • Statistical analysis and interpretation
  • Data visualization and reporting

Module 7: Clinical Trial Project Management

  • Project management principles and methodologies
  • Clinical trial project planning and execution
  • Risk management and mitigation
  • Project monitoring and control

Module 8: Clinical Trial Budgeting and Cost Management

  • Clinical trial budgeting and cost estimation
  • Cost management and control
  • Financial management and reporting
  • Grant management and funding

Module 9: Clinical Trial Contracting and Negotiation

  • Contracting principles and best practices
  • Clinical trial agreement (CTA) development
  • Contract negotiation and management
  • Vendor management and outsourcing

Module 10: Clinical Trial Ethics and Regulatory Compliance

  • Ethical principles in clinical trials
  • Regulatory framework and guidelines
  • Informed consent and patient rights
  • IRB/IEC review and approval

Module 11: Clinical Trial Auditing and CAPA

  • Auditing principles and best practices
  • Clinical trial auditing and CAPA
  • Audit reporting and follow-up
  • Corrective and preventive action (CAPA)

Module 12: Clinical Trial Close-out and Reporting

  • Clinical trial close-out and completion
  • Final reporting and publication
  • Results disclosure and transparency
  • Clinical trial registration and results posting


Certificate of Completion

Upon completing the course, participants will receive a Certificate of Completion issued by The Art of Service. This certificate demonstrates that the participant has acquired the knowledge and skills necessary to master clinical trial management and ensure compliance and mitigate risk.

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