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21 CFR PART 50 Informed Consent of Human Subjects

 4.5/5

29

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

The ethical treatment and safeguarding of the rights and well-being of participants in clinical research is paramount. 21 CFR Part 50 is a set of regulations issued by the FDA in the United States, focusing on the protection of human subjects in clinical trials. This regulation ensures the informed consent process, making certain that participants have a clear understanding of a study’s risks and benefits before deciding to participate.

This certified course delves into the importance of 21 CFR Part 50 by exploring historical incidents, that necessitated the development of these regulations. Through various lessons, the course covers all aspects of 21 CFR Part 50, from its scope and applicability to specific components of informed consent, including guidelines for waiving consent under certain circumstances.

Curriculum:

Introduction

Lesson 1: The Broad Scope of Regulationiij

Lesson 2: Foundations of Informed Consent

Lesson 3: Unpacking the Elements of Informed Consent

Lesson 4: Mastery of Documentation for Informed Consent

Lesson 5: Waiver of Informed Consent – When and How?

Lesson 6: Delving into Emergency Research Regulations

Lesson 7: Safeguarding Children in Research

Conclusion

Glossary

Evaluation

This course is essential for researchers, IRB members, regulatory compliance professionals, and anyone involved in the ethical conduct of clinical research involving human subjects. It provides comprehensive insight into both the principles of 21 CFR Part 50 and the practical implications of adhering to these regulations. It emphasizes the critical importance of informed consent and the historical context that makes these regulations necessary in today’s complex landscape of human subjects research.

Author:

Dr. Patricia Kay

Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.

Reviews:

 4.5/5

29

I found the 21 CFR Part 50 Informed Consent of Human Subjects course by GxP Training incredibly insightful. The format was user-friendly, with each lesson organized around key aspects of informed consent. The blend of historical context with current guidelines gave me a well-rounded understanding. Overall, a clear and concise course that I would recommend to any professional in clinical research.

$60

Participant(s):

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This course includes:

One-year access

Updated content every month

Certificate of completion

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