LEARNING OBJECTIVES
- Understanding of CFR titles and how CFR relates to ICH-GCP
- Learn about the FDA requirements for setup and conduct of clinical trials in the USA
- Learn how to obtain regulatory approvals for clinical trials in the USA
- Understand the requirements and review procedures by the Institutional Review Board (IRB)
- Understand the requirements for an Investigational New Drug application (IND) and New Drug Application (NDA)
- Learn about the financial disclosure requirements for investigators, including record keeping, forms, and responsibilities of sponsors
- Understand the rules for the use of electronic systems and signatures, including validation requirements
- Learn about informed consent processes and forms
- Learn about the specific requirements for the inclusion of minors and vulnerable subjects
DESCRIPTION
The basic online course to CFR for clinical trials in the USA is the ideal introduction to the Code of Federal Regulations (CFR) and specifically zooms in on the parts regulating clinical trials with drug products. This course (English only) identifies investigator and sponsor obligations when setting up and conducting clinical trials in the USA and covers the content of Title 21 of the CFR regulating clinical trials ( Title 21 CFR Part 11, 50, 54, 56, and Title 45 Part 46).
The course is suitable for individuals involved in the setup and conduct of clinical (drug) trials in the USA, who need to learn about the requirements by the FDA in addition to the international ICH-GCP guidelines. It is especially applicable to anyone involved in the Design, Conduct, Oversight, or Management of Clinical Trials with Drugs and/or Biologics in the USA, such as Clinical Research Organizations (CROs), Sponsors, Investigators, Key Study Personnel, Research Nurses, and Clinical Research Coordinators.
Key course components:
- Highly interactive
- Written by CFR experts
- FDA-focused training
- Including expert interviews
- Including practical case scenarios and handy tools
- A unique addition to your ICH GCP knowledge (*)
*Important note: This new course is covering the additional requirements which the CFR adds to ICH GCP. So, before starting your CFR training, make sure you have completed your ICH GCP training.
All of our training courses come with a full one-year license of continuous learning so you can stay up-to-date with changing regulations and guidelines. After you’ve completed your course, you’ll earn your crucial CFR Certificate.
Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.
COURSE CONTENTS
Module: Introduction
- General introduction to the CFR Titles regulating clinical research in the USA
- How the content of the CFR relates to ICH GCP
- Requirements and review procedures by IRB, including expedited reviews
- Requirements for an Investigational New Drug application (IND) and New Drug Application (NDA)
- Financial disclosure requirements for investigators, including recordkeeping, forms (FORM FDA 3454, and 3455) and the responsibilities for sponsors
- How regulatory approval for clinical trials in the USA can be obtained
- Requirements to the IRB, its composition, method of operation, types of reviews, and review process
- Rules for the use of electronic systems and the use of electronic signatures, documented in CFR Part 11
- The CFRs additional requirements to the informed consent process and forms, including vulnerable subjects
- Specific requirements to the inclusion of minors in research, including the informed consent process
- Specific requirements to the documentation of informed consent in case of illiteracy, including short form
- Conditions to be met when performing research in emergency situations where prior informed consent is not feasible
GCP Central –
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