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ISO 14155 Compliance Checklist and Implementation Guide for Clinical Trials Management

ISO 14155 Compliance Checklist and Implementation Guide for Clinical Trials Management

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ISO 14155 Compliance Checklist and Implementation Guide for Clinical Trials Management Course Curriculum

This comprehensive course is designed to provide participants with a thorough understanding of ISO 14155 compliance and its application in clinical trials management. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Overview

This interactive and engaging course is structured into 8 modules, covering over 80 topics related to ISO 14155 compliance and clinical trials management. The curriculum is designed to be comprehensive, practical, and applicable to real-world scenarios.



Course Outline

Module 1: Introduction to ISO 14155 and Clinical Trials Management

  • Overview of ISO 14155 and its significance in clinical trials
  • History and evolution of ISO 14155
  • Key principles and objectives of ISO 14155
  • Clinical trials management: an overview
  • Importance of compliance in clinical trials

Module 2: Understanding the ISO 14155 Standard

  • Detailed review of the ISO 14155 standard
  • Key requirements and clauses
  • Understanding the scope and applicability of ISO 14155
  • Interpretation of ISO 14155 requirements
  • Case studies: applying ISO 14155 in clinical trials

Module 3: Clinical Trials Management Systems

  • Designing and implementing a clinical trials management system
  • Key components of a clinical trials management system
  • Roles and responsibilities in clinical trials management
  • Documentation and record-keeping requirements
  • Training and awareness programs for clinical trials personnel

Module 4: Risk Management in Clinical Trials

  • Risk management principles and methodologies
  • Identifying and assessing risks in clinical trials
  • Developing risk mitigation strategies
  • Monitoring and reviewing risk management plans
  • Case studies: risk management in clinical trials

Module 5: Quality Management in Clinical Trials

  • Quality management principles and methodologies
  • Quality planning and quality control in clinical trials
  • Quality assurance and quality improvement
  • Auditing and monitoring clinical trials
  • Corrective and preventive actions (CAPA) in clinical trials

Module 6: Compliance and Regulatory Requirements

  • Overview of regulatory requirements for clinical trials
  • Compliance with GCP, ICH, and other regulatory guidelines
  • Understanding the role of ethics committees and IRBs
  • Informed consent and participant rights
  • Regulatory inspections and audits

Module 7: Implementing ISO 14155 in Clinical Trials

  • GAP analysis and readiness assessment
  • Developing an implementation plan for ISO 14155
  • Establishing a compliance framework
  • Training and awareness programs for ISO 14155
  • Internal audits and management review

Module 8: Maintaining Compliance and Continuous Improvement

  • Ongoing compliance and surveillance
  • Continuous monitoring and improvement
  • Management review and re-certification
  • Handling non-conformities and deviations
  • Best practices for maintaining ISO 14155 compliance


Course Features

This course is designed to be:

  • Interactive: Engaging exercises and quizzes to reinforce learning
  • Comprehensive: Covering over 80 topics related to ISO 14155 and clinical trials management
  • Personalized: Opportunities for feedback and guidance from expert instructors
  • Up-to-date: Incorporating the latest developments and best practices in clinical trials management
  • Practical: Focusing on real-world applications and case studies
  • High-quality content: Developed by experts in the field of clinical trials management
  • Flexible learning: Self-paced online learning with lifetime access
  • User-friendly: Easy navigation and mobile accessibility
  • Community-driven: Opportunities for discussion and networking with peers
  • Actionable insights: Providing practical takeaways and recommendations
  • Hands-on projects: Applying learning to real-world scenarios
  • Bite-sized lessons: Breaking down complex topics into manageable chunks
  • Gamification: Using game design elements to enhance engagement and motivation
  • Progress tracking: Monitoring progress and achievement


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their expertise and knowledge in ISO 14155 compliance and clinical trials management.

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