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Compliance In Focus
Posted by Brandy Chittester on Thu, Jun 27, 2019

A Foolproof Approach To Clinical Research Training: The FAIR Shake™ Method

 

Although there are no formal requirements for clinical research training, it's an important step to conducting studies in accordance with federal regulations. 

Clinical-research-training

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:

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.

For a reference guide to help you with clinical research training, download our FAIR Shake™ whitepaper.

And if you'd like to learn more about how IMARC can help your team with clinical research training, browse our course catalog

IMARC University Course Catalog

 

 

 

Topics: FAIR Shake™ Training Method, Clinical Research

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