Onyedikachi
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Posted on 25/05/2026
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.

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
User from
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Posted on 25/05/2026
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Posted on 22/10/2026
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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.