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Friday, June 18, 2021
Home » Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects [Part 2]

Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects [Part 2] (ELM-910)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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Biopharma Institute LogoTraining Program: Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects [Part 2]
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsAccording 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.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects [Part 2] course is included in the following Professional Certification Programs:



Informed Consent of Human Subjects for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

Informed Consent of Human Subjects for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Program Introduction
Who Should Take This Program?
Definitions
Learning Objectives

Sec. 50.24 Exception from Informed Consent Requirements for Emergency Research
Section (a) (1) (2) (i - iii) (3) (i-iii) [Part 1] - Approve without Informed Consent
Section (a) (4) (5) (6) [Part 2] - Exceptions of Waiver
Section (a) (7) (i-v) [Part 3] - Exceptions of Waiver for Emergency Research
Section (b) (c)- Sensitize Specific Individuals
Section (d) (e) - Investigational Device Exemption

Sec. 50.25 Elements of Informed Consent
Section (a) (1-8): Basic Elements of Informed Consent [Part 1]
Section (b) (1-6): Additional Elements of Informed Consent
Section (c) (d) (e): Additional Elements of Informed Consent [Part 2]

Conclusion


Final Assessment


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Good Clinical Practices (cGCP).

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