ICH E6, Good Clinical Practice, GCP, clinical trials, research ethics, informed consent, trial monitoring, quality management, UK clinical research

Good Clinical Practice

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5 Chapters

1 Hour

Good Clinical Practice

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.

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£4.00

Good Clinical Practice

5 Chapters

1 Hour

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ICH E6 and Good Clinical Practice

About The Course

Learning Outcomes

Course Modules

1

About The Course

GCP represents the global standard for the design, conduct, recording, and reporting of clinical trials involving human participants. The course explains the foundational principles underpinning GCP, including adherence to ethical conduct as outlined in the Declaration of Helsinki, ensuring a scientifically sound trial design, and implementing robust quality management systems. Recent updates emphasise risk-based approaches, participant-centric trial conduct, and integration of digital health technologies. The course covers responsibilities of investigators, sponsors, and ethics committees, informed consent processes, safety reporting, and confidentiality

2

Learning Outcomes

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.

3

Course Modules

Chapter 1 Introduction to Good Clinical Practice (GCP)

Chapter 2 Ethical Principles and Protection of Participants

Chapter 3 Roles and Responsibilities in Clinical Research

Chapter 4 Quality Management and Trial Conduct

Chapter 5 Summary and Review

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