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21 CFR PART 50 Informed Consent of Human Subjects

4.5/5
(71 reviews)
21 CFR PART 50

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 : 21 CFR PART 50 Informed Consent of Human Subjects

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:

patricia kay
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
(71 reviews)
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.
Marcus TampetaClinical Research Director
USD: United States (US) dollar ($) ^

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

  • Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
  • Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
  • Self-paced : access 24/7 to the course during 12 months at your own rhythm.
  • Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
  • Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
  • Instant Purchase : one click to buy and immediate access. Get certified today.
  • LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
  • HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
  • Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
  • LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.
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$95.00 / year

$95.00 / year

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About us

GxP Training is a service provided by Axeda SRL, a recognized leader in digital regulatory learning. Axeda specializes in compliance training and assessment solutions specifically designed for life sciences companies and professional training organizations.

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