Good Clinical Practices: A Practical Guide to GCP Compliance

Categories: Compliance
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About Course

Understand the Ethical and Regulatory Framework for Conducting Clinical Trials

 

Course Description

This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research.

Course Objectives

By the end of this course, you will be able to:

  • Articulate the definition, purpose, and historical context of GCP.
  • Explain the importance of GCP in protecting human subjects and ensuring data integrity.
  • Identify key international organizations involved in establishing GCP standards.
  • Apply ethical principles and informed consent procedures in clinical research.
  • Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
  • Design and conduct clinical trials according to ICH E8 and E9 guidelines.
  • Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
  • Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
  • Navigate regulatory compliance and inspections related to clinical trials.

Target Audience

This course is designed for individuals who:

  • Are interested in pursuing a career in clinical research or clinical trial management.
  • Work in the pharmaceutical, biotechnology, or medical device industry.
  • Seek to gain a comprehensive understanding of GCP principles and practices.

Prerequisites

No prior experience in clinical research is required. However, a basic understanding of research methodology and medical terminology is recommended.

Please Note:

This course is strictly theoretical and does not qualify participants for clinical practice in the industry. Additional training and certifications may be required for hands-on experience.

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What Will You Learn?

  • Articulate the definition, purpose, and historical context of GCP.
  • Explain the importance of GCP in protecting human subjects and ensuring data integrity.
  • Identify key international organizations involved in establishing GCP standards.
  • Apply ethical principles and informed consent procedures in clinical research.
  • Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
  • Design and conduct clinical trials according to ICH E8 and E9 guidelines.
  • Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
  • Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
  • Navigate regulatory compliance and inspections related to clinical trials.

Course Content

Introduction to Good Clinical Practice (GCP) and ICH Guidelines

  • Introduction to Good Clinical Practice (GCP) and ICH Guidelines
    00:00

Ethical Principles, Informed Consent, and ICH E6(R2)

Designing and Conducting Clinical Trials with ICH E8 and E9

Data Management and Reporting with ICH E6(R2)

Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3)

Regulatory Compliance, Inspections, and ICH E6(R3)

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