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Good Clinical Data Management Practice; Mastering the Fundamentals

Good Clinical Data Management Practice; Mastering the Fundamentals

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Good Clinical Data Management Practice: Mastering the Fundamentals



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of good clinical data management practices, including the principles, concepts, and regulations that govern clinical data management. Participants will learn how to ensure the quality, integrity, and reliability of clinical data, and how to manage clinical data in compliance with regulatory requirements.



Course Objectives

  • Understand the principles and concepts of good clinical data management practices
  • Learn how to ensure the quality, integrity, and reliability of clinical data
  • Understand the regulatory requirements for clinical data management
  • Learn how to manage clinical data in compliance with regulatory requirements
  • Gain practical experience in clinical data management through hands-on projects and case studies


Course Outline

Module 1: Introduction to Clinical Data Management

  • Definition and scope of clinical data management
  • Importance of clinical data management
  • Overview of the clinical data management process
  • Roles and responsibilities in clinical data management

Module 2: Principles of Good Clinical Data Management Practice

  • Principles of good clinical data management practice
  • Data quality and integrity
  • Data validation and verification
  • Data security and confidentiality

Module 3: Clinical Data Management Regulations and Guidelines

  • Overview of regulatory requirements for clinical data management
  • ICH E6 (R2) Good Clinical Practice
  • 21 CFR Part 11 Electronic Records and Electronic Signatures
  • EU GDPR and Clinical Data Management

Module 4: Clinical Data Management Systems and Tools

  • Overview of clinical data management systems and tools
  • Electronic Data Capture (EDC) systems
  • Clinical Data Management Systems (CDMS)
  • Data Management Plan (DMP)

Module 5: Data Management Planning and Study Setup

  • Data management planning and study setup
  • Development of a Data Management Plan (DMP)
  • Study setup and configuration
  • Data validation and verification

Module 6: Data Collection and Data Entry

  • Data collection and data entry
  • Electronic Data Capture (EDC) systems
  • Data entry and data validation
  • Data quality and integrity

Module 7: Data Cleaning and Data Validation

  • Data cleaning and data validation
  • Data validation rules and checks
  • Data cleaning and data normalization
  • Data quality and integrity

Module 8: Data Analysis and Reporting

  • Data analysis and reporting
  • Statistical analysis and data interpretation
  • Data visualization and reporting
  • Results and conclusions

Module 9: Clinical Data Management Best Practices

  • Clinical data management best practices
  • Data quality and integrity
  • Data validation and verification
  • Data security and confidentiality

Module 10: Case Studies and Practical Applications

  • Case studies and practical applications
  • Real-world examples of clinical data management
  • Hands-on projects and group discussions
  • Practical experience in clinical data management


Certificate of Completion

Upon completion of the course, participants will receive a Certificate of Completion issued by The Art of Service.



Course Features

  • Interactive and engaging course content
  • Comprehensive and up-to-date course materials
  • Personalized learning experience
  • Practical and real-world applications
  • High-quality content and expert instructors
  • Certification upon completion
  • Flexible learning options and user-friendly interface
  • Mobile-accessible and community-driven
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking


Course Format

The course is delivered online and consists of 10 modules, each with a series of lessons, quizzes, and hands-on projects. Participants can access the course materials and complete the coursework at their own pace.



Target Audience

This course is designed for clinical data managers, clinical research coordinators, data analysts, and anyone involved in the management of clinical data.



Prerequisites

There are no prerequisites for this course, but a basic understanding of clinical research and data management principles is recommended.

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