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.
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.
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
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.
$60.00 / year