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Good Clinical Practice

Trending3.5(New)

This course provides a comprehensive overview of the International Council for Harmonisation (ICH) E6 guideline on Good Clinical Practice (GCP). It equips clinical research professionals with the knowledge and skills needed to ensure ethical, high-quality clinical trials that protect participant rights, safety, and data integrity.

5 Modules1 hour
€169€0
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Good Clinical Practice
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Learning Outcomes

What you'll learn

  • Describe the core principles and objectives of GCP guidelines.
  • Recognize the ethical and scientific basis for the conduct of clinical trials.
  • Understand roles and responsibilities of key stakeholders, including investigators and sponsors.
  • Apply requirements for informed consent and participant safety.
  • Implement risk-based quality management and compliance monitoring.
  • Identify recent changes in enhancing the applicability and quality of clinical trials globally.

Modules

Module 1

Introduction to Good Clinical Practice (GCP)

Module 2

Ethical Principles and Protection of Participants

Module 3

Roles and Responsibilities in Clinical Research

Module 4

Quality Management and Trial Conduct

Module 5

Summary and Review

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Frequently Asked Questions

GCP ensures clinical trials are conducted ethically and scientifically, protecting participant rights, safety, and well-being while producing reliable and credible data.

Informed consent respects participant autonomy by ensuring individuals understand the trial’s purpose, risks, benefits, and their right to withdraw at any time.

The Principal Investigator (PI) is responsible for overseeing trial conduct, participant safety, protocol compliance, and data integrity at the study site.

Quality management uses SOPs, training, monitoring, and accurate documentation to maintain participant safety, data integrity, and regulatory compliance throughout the trial.