Although there are no formal requirements for clinical research training, it's an important step to conducting studies in accordance with federal regulations.
Everyone involved in a clinical trial—from the sponsor and principal investigator to research coordinators and monitors—must have a fundamental understanding of these regulations so they can address concerns that will inevitably arise during the study.
To guide researchers through the complex maze of regulations, IMARC developed clinical research training known as The FAIR Shake™ program.
Here's a closer look at what's covered in The FAIR Shake and how to apply it to your next trial.
What Is The FAIR Shake™ Clinical Research Training Program?
The FAIR Shake™ program clarifies the roles of the principal investigator and sponsor during a clinical research study and helps them navigate the four main areas of regulatory compliance.
FAIR is an acronym for each of these four main areas:
- Federal regulations
- Agreements with the sponsor
- Investigational plan
- Requirements of the Institutional Review Board (IRB)
The principal investigator is required to conduct studies in according with these regulations. The sponsor is responsible for overseeing the study and ensuring the investigator complies with these regulations.
How to Apply The FAIR Shake To Your Studies
The FAIR Shake™ program is designed to give teams a fundamental understanding of federal regulations designed to conduct safe, ethical studies and how to apply them.
These regulations include:
- CFR 312 - Investigational New Drugs
- CFR 812 - Investigational Device Exemptions
- CFR Part 50, Title 21 - Protection of Human Subjects
- CFR Part 56 - Regulations of Investigational Review Boards
- CFR Part 54 - Financial Disclosures
- CFR 11 - Electronic Records and Signatures
At any point in your trial, your team may be presented with questions related to patient enrollment, informed consent, data recording or any number of other issues. They can use the FAIR Shake™ framework to answer these questions by asking:
- Is it required in the federal regulations?
- Is it required in the agreement?
- Is it required in the investigational plan?
- Is it required by the IRB?
This technique will help you answer questions with confidence.