21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 1]
Description:
According to the Code of Federal Regulations, 21 CFR Part 50 “applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products.”
Curriculum for this course:
Program Introduction
| Who Should Take This Program? | 1 min 01 secs |
| Definitions | 1 min 31 secs |
| Learning Objectives | 1 min 21 secs |
Sec. 50.20: General Requirements for Informed Consent
| Sec. 50.20: General Requirements for Informed Consent | 1 min 05 sec |
Sec. 50.23 Exception from General Requirements
| Section (a) 1 – 4: Foregoing Consent [Part 1] | 1 min 12 secs |
| Section (b) and (c): Foregoing Consent [Part 2] | 1 mins 29 secs |
| Section (d) 1: Waiving of consent for armed force members | 1 min 02 secs |
| Section (d) (1) i – v: Requirements that DOD needs to adhere to [Part 1] | 1 min 25 secs |
| Section (d) (1) vi, (a) (b) © (vii-x): Requirements that DOD needs to adhere to [Part 2] | 1 min 10 secs |
| Section (d) (1) (xi-xviii): Requirements to DOD must adhere to [Part 3] | 1 min 38 secs |
| Section (d) (2) (3) (i-iv) (4) (5): The Institutional Review Board – Part A | 1 min 30 secs |
| Section (d) (2) (3) (i-iv) (4) (5): The Institutional Review Board – Part B | 1 min 11 secs |
| Section (e) (1) (i – ii) (A) (B) (iii -iv): Informed Consent for Investigational in Vitro Diagnostic Devices [Part 1] | 1 min 14 secs |
| Section (e) (2) (3): Informed Consent for Investigational in Vitro Diagnostic Devices [Part 2] | 1 min 01 secs |
| Section (e) (3) (4) (5): The Report and the IRB – Part A | 1 min 22 secs |
| Section (e) (3) (4) (5): The Report and the IRB – Part B | 1 min 40 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-909 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This is the most critical aspect of conducting a clinical trial. We have made this course a mandatory requirement for anyone associated with the process.
Informed consent explained in a clear concise way that everyone can understand.
Related courses:
An Introduction to Good Clinical Practices (cGCP) – Part 1
An Introduction to Good Clinical Practices (GCP) – Part 2
An Introduction to Good Clinical Practices (cGCP) – Part 3
cGMP – Cases from History and the Regulations
Good Laboratory Practices: History and Regulatory Compliance
How to be an Effective GMP Auditor – Part 1
Sources of Contamination in a GMP Environment
How to Write Effective Standard Operating Procedures (SOPs)
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