Introducing the newest addition to our GCP  course catalog: Basic CFR Course For Clinical Trials In The USA

The introductory online course to CFR for clinical trials in the USA is the ideal introduction to the Code of Federal Regulations (CFR). Specifically, it zooms in on the parts regulating clinical trials with drug products.

This course identifies investigator and sponsor obligations when setting up and conducting clinical trials in the USA. It 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).

But what does the course entail, and who is the course for?

What is the Code Of Federal Regulations (CFR)?

The Code of Federal Regulations contains the specific interpretation of US law by government agencies. The FDA is one such agency that outlines in the CFR how the US drug laws are implemented.

We have built this online training course on the CFR, covering the specific guidelines needed for trial compliance within the United States. These sections govern food and drugs for the Food and Drug Administration (FDA) and are relevant to clinical trials for products. We also cover additional requirements by the Department of Health and Human Services (HHS).

We specifically cover the following areas:

  • 21 CFR Part 11 – Electronic Systems And Signatures
  • 21 CFR 50 – Protection Of Human Subjects
  • 21 CFR 54 – Financial Disclosure By Clinical Investigators
  • 21 CFR 56 – Institutional Review Boards
  • 45 CFR 46 – Protection Of Human Subjects

*Important note: This new course covers additional requirements for compliance within the CFR.  While the US does not mandate GCP, this course covers the parts that are different or in addition to ICH-GCP.

Who is the CFR Training course for?

This course is suited to those who are involved in the Design, Conduct, Oversight, or Management of Clinical Trials with Drugs and Biologics in the USA, such as Clinical Research Organizations (CROs), Sponsors, Investigators, Key Study Personnel, Research Nurses, and Clinical Research Coordinators.

Investigators and research staff:

Investigators and research staff involved in drug, and biologic studies (and working on sites) in the USA, this course will help you to understand the additional requirements by the FDA on the conduct of clinical trials in the USA.

Sponsors and CRO staff:

Sponsors and CRO staff working for clients who need to set up or conduct clinical trials in the USA or under US-law (CFR/IND) will find this course beneficial.

Site initiation staff CROs:

This course will help CRO staff who need to set up clinical research sites in the USA.

Clinical Research Associates:

CRAs who need to monitor clinical trials under US-law (CFR/IND) will find this course suitable for their needs.

What are the learning objectives for this course?

This interactive, online course is written by CFR experts with FDA focused training and includes interviews with experts, practical case scenarios, and helpful tools –  all while adding to and reinforcing your ICH GCP knowledge.

You’ll learn:

  • An understanding of CFR titles and how CFR relates to ICH-GCP
  • The FDA requirements for setup and conduct of clinical trials in the USA
  • How to obtain regulatory approvals for clinical trials in the USA
  • The requirements and review procedures by the Institutional Review Board (IRB)
  • The financial disclosure requirements for investigators, including record keeping, forms, and responsibilities of sponsors
  • The rules for the use of electronic systems and signatures, including validation requirements
  • Informed consent processes and forms
  • Specific requirements for the inclusion of minors and vulnerable subjects

Our new Basic CFR Course for Clinical Trials In The USA is tailor-made for busy clinical research professionals. Learn on the go, and keep your knowledge continuously up to date with GCP Central. Are you ready to take your CFR learning to the next level?

Learn more about the course, it’s learning objectives, and course module content here or visit the Dutch language page here.