About the Course
Introduction to this course:
In this course, we will introduce the fundamentals of Good Clinical Practices (GCP), its historical context, the regulatory framework ruling clinical trials, some historical background of the Declaration of Helsinki, and the roles and responsibilities of all professionals taking part in clinical trials.
Who should attend:
This course is ideal for clinical researchers, healthcare professionals, regulatory affairs specialists, and anyone involved in clinical trials and drug development.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify the key principles of Good Clinical Practices and major regulatory bodies (FDA, EMA).
Explain the historical context and ethical foundations, including the Declaration of Helsinki of Good Clinical Practices.
Implement Good Clinical Practice guidelines in the design and conduct of clinical trials.
What will I gain:
Participants will gain a comprehensive understanding of GCP principles and the skills to apply ethical and regulatory standards in clinical trials.
Prerequisites:
Prerequisites for this course include basic knowledge of clinical research. Familiarity with medical terminology is recommended.
Additional information:
Course duration: 00:23:37
Course code/version (effective date): L-151/v1.0 (12/03/2024)
Course Categories
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Good Clinical Practices (GCP): Introduction, background, and responsibilities
- Lesson 1: Introduction to GCP
- Lesson 2: Clinical Trials Regulation: Roles and Responsibilities (Part 1)
- Lesson 3: Clinical Trials Regulation: Roles and Responsibilities (Part 2)
- Reading: Good Clinical Practice (GCP): Glossary
-
Additional resources
- Mind Map: Good Clinical Practices
-
Survey
- Course survey
About the Course
Introduction to this course:
In this course, we will introduce the fundamentals of Good Clinical Practices (GCP), its historical context, the regulatory framework ruling clinical trials, some historical background of the Declaration of Helsinki, and the roles and responsibilities of all professionals taking part in clinical trials.
Who should attend:
This course is ideal for clinical researchers, healthcare professionals, regulatory affairs specialists, and anyone involved in clinical trials and drug development.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify the key principles of Good Clinical Practices and major regulatory bodies (FDA, EMA).
Explain the historical context and ethical foundations, including the Declaration of Helsinki of Good Clinical Practices.
Implement Good Clinical Practice guidelines in the design and conduct of clinical trials.
What will I gain:
Participants will gain a comprehensive understanding of GCP principles and the skills to apply ethical and regulatory standards in clinical trials.
Prerequisites:
Prerequisites for this course include basic knowledge of clinical research. Familiarity with medical terminology is recommended.
Additional information:
Course duration: 00:23:37
Course code/version (effective date): L-151/v1.0 (12/03/2024)
-
Good Clinical Practices (GCP): Introduction, background, and responsibilities
- Lesson 1: Introduction to GCP
- Lesson 2: Clinical Trials Regulation: Roles and Responsibilities (Part 1)
- Lesson 3: Clinical Trials Regulation: Roles and Responsibilities (Part 2)
- Reading: Good Clinical Practice (GCP): Glossary
-
Additional resources
- Mind Map: Good Clinical Practices
-
Survey
- Course survey
