Benefits of Technology to Sites
I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! We are continuing our conversation on technology and the benefits to sites and the industry with the use of technology. Today we are going to talk about electronic regulatory documentation. What is regulatory in our world? Regulatory documents include Principal Investigator medical licenses and their CV/resume, and more importantly in the U.S. it also includes FDA Form 1572, where the Investigator is saying they take complete responsibility for what happens at their site. There is a delegation of authority log where that Investigator is saying “I’m delegating authority to my other colleagues here in the office to be able to do physical exams for me, to review labs for me, or perform pulmonary function tests for me.” Delegation of authority logs should be backed up with evidence that people being delegated to have appropriate the education/training/ schooling to be able to perform those functions. And there is more in that regulatory binder.
Traditional Regulatory Binders
Most regulatory binders today are paper. It’s pieces of paper in a 3-ring binder that documents all of this. Why is that an issue? As always, it’s too easy to make mistakes. Think about that delegation of authority log – it’s very easy for me to delegate authority for somebody to do pulmonary function testing without any documentation that person has adequate experience to do accurate pulmonary function testing. If that person really doesn’t have adequate experience, I shouldn’t be allowed to delegate authority to that person to do that test. On paper it’s very easy to do; it’s very easy to make mistakes. I can have a physician on a research trial whose medical license expired on March 31st of this year. It’s now May and someone looks in that regulatory binder and there is no current medical license for that physician. Most often that doctor did renew their medical license, but we didn’t put a copy of it in that regulatory binder. That’s pretty easy to fix. But what if the doctor actually overlooked renewing their license, and for two months that doctor was performing research without a medical license to do so? That would be a huge deal. On paper, that is the kind of error that could happen, and there wouldn’t be much to stop that kind of error. Electronic regulatory binders prevent that.
How Do Electronic Regulatory Binders Prevent Errors?
In an electronic format, if my medical license is expiring, that computer system is screaming at me. I’m getting emails, text messages, and other people in the office are getting emails and text messages saying, “Dr. Kingsley’s medical license is expiring next month.” You can program it for whatever alerts you want, even warning you two months in advance, and accelerating the warnings until such time we update the medical license.
Anybody that I delegate authority to do different functions should have backup supporting material of their experience and training. I need proof that they can do what I delegated the authority for them to do. It could be in the form of a nursing license, medical license, certifications, or prior testings proving that a person can do those functions. Electronic regulatory documents allow us to do all of those things.
The Benefits are Efficiency and Quality
The benefit is efficiency and quality. In my opinion, the number one benefit is quality. I’m all about improving the quality of research. Electronic regulatory binders that have some intelligence behind them dramatically improve the quality of the regulatory documentation of the research trial we are conducting. They also improve the efficiency. We are running around trying to find documentation that, on paper, could be misplaced. Someone could have opened that 3-ring binder and the paper fell out and scattered onto the floor. Electronic documentation dramatically improves the efficiency.
Who is the Real Beneficiary?
The real beneficiary is Sponsors. They are the true beneficiary of a site’s investment in electronic regulatory documentation. How does the industry need to respond? It’s a virtuous cycle. The industry needs to say “Sites that invest in infrastructure that dramatically improve quality and efficiency, and ultimately benefit us as Sponsors, we will preferentially want those sites on our trials. And we will compensate those sites for that investment that they made to benefit us on our trial. We will compensate those sites monetarily in their budgets for the fact that the site had to spend money, and will continue to spend money, to implement that electronic system.” If Sponsors are willing to compensate sites in the form of study awards and contract/budget terms, more sites will then implement the electronic regulatory systems. It’s a virtuous cycle. That’s where the industry needs to get. It needs to get to a point where sites are elevating their performance – professionalization of our industry. I believe it’s mandatory that our sites start working on electronic platforms that improve quality and efficiency. But Sponsors need to recognize the investment and compensate appropriately. And Sponsors need to incentivize sites and raise the bar to be competitive to those sites that have made the infrastructure investment.
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