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Mastering ISO 14155 Compliance with Practical Excel Implementation

Mastering ISO 14155 Compliance with Practical Excel Implementation

$299.00
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Mastering ISO 14155 Compliance with Practical Excel Implementation



Course Overview

This comprehensive course is designed to equip participants with the knowledge and skills necessary to master ISO 14155 compliance and implement it practically using Excel. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Objectives

  • Understand the principles and requirements of ISO 14155
  • Learn how to implement ISO 14155 in a clinical investigation setting
  • Develop practical skills in using Excel to support ISO 14155 compliance
  • Gain confidence in applying ISO 14155 principles in real-world scenarios


Course Outline

Module 1: Introduction to ISO 14155

  • Overview of ISO 14155 and its importance in clinical investigations
  • History and evolution of ISO 14155
  • Key principles and requirements of ISO 14155
  • Understanding the role of ISO 14155 in ensuring data quality and integrity

Module 2: Understanding Clinical Investigations

  • Definition and types of clinical investigations
  • Roles and responsibilities in clinical investigations
  • Ethical considerations in clinical investigations
  • Regulatory requirements for clinical investigations

Module 3: ISO 14155 Requirements for Clinical Investigations

  • Pre-investigation planning and preparation
  • Conducting clinical investigations: procedures and documentation
  • Data management and quality control
  • Monitoring and reporting adverse events

Module 4: Practical Excel Implementation for ISO 14155 Compliance

  • Introduction to Excel for data management
  • Designing and implementing data collection templates
  • Data cleaning and validation techniques
  • Using Excel formulas and functions for data analysis

Module 5: Data Management and Quality Control

  • Principles of data management in clinical investigations
  • Data quality control measures
  • Data validation and verification techniques
  • Using Excel to support data quality control

Module 6: Monitoring and Reporting Adverse Events

  • Definition and classification of adverse events
  • Procedures for reporting and documenting adverse events
  • Using Excel to track and report adverse events
  • Best practices for adverse event management

Module 7: Auditing and Compliance

  • Principles of auditing in clinical investigations
  • Conducting audits: procedures and documentation
  • Identifying and addressing non-compliances
  • Using Excel to support audit activities

Module 8: Case Studies and Group Exercises

  • Real-world case studies: applying ISO 14155 principles
  • Group exercises: implementing ISO 14155 in different scenarios
  • Peer review and feedback
  • Action planning for implementation


Course Features

  • Interactive: Engaging video lessons, quizzes, and exercises
  • Comprehensive: In-depth coverage of ISO 14155 and Excel implementation
  • Personalized: Opportunities for feedback and support
  • Up-to-date: Latest information and best practices in ISO 14155 compliance
  • Practical: Hands-on projects and real-world applications
  • High-quality content: Developed by expert instructors
  • Certification: Certificate issued by The Art of Service upon completion
  • Flexible learning: Self-paced online learning
  • User-friendly: Easy-to-use online platform
  • Mobile-accessible: Access course materials on-the-go
  • Community-driven: Discussion forums and peer support
  • Actionable insights: Practical takeaways and implementation guidance
  • Hands-on projects: Applying ISO 14155 principles in real-world scenarios
  • Bite-sized lessons: Manageable chunks of learning
  • Lifetime access: Access course materials for a lifetime
  • Gamification: Engaging learning experience with rewards and recognition
  • Progress tracking: Monitor your progress and stay on track


What to Expect Upon Completion

Upon completing the course, participants will receive a certificate issued by The Art of Service, demonstrating their mastery of ISO 14155 compliance and practical Excel implementation.

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