6 Essential Tools For Any IRB Software
— June 2016 —
We researchers know what IRB software is — but often times evaluating systems and the companies behind them, is difficult. It is hard to move beyond the superficial information gleaned from the sales representative you might meet at a yearly conference; if you are lucky enough to have the budget to attend one. In my experience as a Research Compliance Officer the essentials are actually quite simple. I’ve boiled the list down to the six “must-haves” for any compliance software you consider:
Setup and Configuration Made Easy
You need to be able to customize your IRB system so you don’t have to deal with things like questions on a Phase I clinical trial if you’re working at a social –behavioral institution. Nobody wants to answer nonsensical questions.
So you should be able to add and remove anything that doesn’t apply with aclick of a button; not rely on IT support staff to do this for you. It is critical that you be able to simplify the application by, for instance, having IRB options only. And it goes without saying that you should be able to write your own questions and easily insert them into the program.
Make the Training Process Easy
An intuitive interface, strong set of FAQs and to some short video are all huge time-savers. Providing new users with these shortcuts will save you time and reduce frustrations for everyone involved.
Finding the “Stuck” Submission
A clear picture of the status of a PI’s application and where it might be held up is key. Incomplete applications risk being withdrawn without the proper response. I know we have all had a moment of guilt and allowed a little more time for that last document. A good system should help you avoid these situations.
Communication is Key
If Dr. Smith puts in a grant submission to NIH for a gigantic (and hopefully successful) award, you need Dr. Smith to also know that an IRB protocol needs to be submitted. You want Dr. Smith to know that even though she didn’t get her money yet, there are other areas she needs to address so she can hit the ground running when she gets that exciting award notice. You don’t want anyone telling her to wait, because, let’s face it, at that point it becomes your problem. Communicating modules are key so that no one is held back and so that regulations and rules are followed.
Reliable and Friendly Customer Service
On this issue there is no substitute for doing your homework by calling existing customers and getting a good idea of their experience with the company. If you have a PI working on a last minute submission (sometimes it seems as though they all are), and there’s a glitch that you can’t handle, you need a partner who is there when you call. Good customer service plays an important role in making your department work efficiently and making you more effective. In addition to talking to existing customers, pay attention to the kinds of responses you’re getting when evaluating the system. If they don’t have time to answer your questions before you’ve signed a contract odds are pretty good they won’t make time to help you after they’ve been paid. Another customer service consideration is how updates to the system are handled. Be sure to understand the procedures around updates (and make sure you ask about this when speaking with current users). You shouldn’t be surprised if your vendor has a brief shut-down for an update or even overhauls the system. But, good communication from the company will make these minor inconveniences rather than major headaches.
Get the Most “Bang” For Your Buck
Prices vary widely. Don’t throw money away on a system that can’t meet the above basic needs (and they are basic). At the same time, there’s no reason to spend tens of thousands of dollars on a system that is over-engineered for your institution.
I think a good online IRB system is one that saves everyone time and energy and is not a barrier to the success of a researcher or a supportive research compliance office staff. I guess I should mention that it should also cuts down on complaints…now that’s another list.
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Cristy McGoff has a research compliance background spanning almost 12 years, and is currently the director of a research compliance office at a mid-size university in the U.S.
In her spare time, she enjoys sewing and reading about the latest scandals and advancements in the world of research.