Congratulations! Your department has been given the go-ahead to convert its antiquated IRB compliance system to a state-of-the-art online mentor IRB system that will save researchers and their staff time and funds that are better spent elsewhere.
Several systems claim that they will solve all your time, cost, and compliance needs. So how do you decide which system is right for your department?
The answer is, by comparing systems methodically.
Comparisons start with a list of your criteria
We recommend that you initiate your decision-making process by asking researchers and their administrators to specify what they need their new Software as a Service to accomplish for them.
Our recent post, 6 Things to Look for in IRB Software—A Research Administrator’s Perspective, is a great resource to support this first step. It’s a list of six must-have features recommended by the voice of experience, a former research compliance officer:
- Customizable, set-up specifically for IRB research
- Built-in, user-friendly tech support (intuitive interface, inclusive FAQs page, and video demonstrations)
- Fast, accurate submission status reports to identify submissions that are being held up
- Compliance-related communicating modules that keep the submission process moving forward
- Customer tech support when and how you need it
- A system that fits your budget and research requirements—no more and no less.
As that last point suggests, once you get past the basics, you’ll also need to expand your list to include the remaining criteria your research department needs in its online research compliance system.
So, be as thorough as you can in this step. Remember that your new SaaS system should be a one-time investment that will meet your department’s research and compliance requirements over time.
Consider adding the following criteria to your list.
Flexibility and ease of customization
Your department’s research focus may change and/or grow over time. You can count on changes to regulatory hoops as well. You should be able to reconfigure and scale your SaaS system to meet your department’s ongoing requirements.
Ease of start-up
Current PIs and staff should be able to use the new system with little introductory training. Later, as PIs or staff leave and new ones come aboard, use of the SaaS system should be easily accessible. A system that does not have ease of entry just shifts your program from one frustrating burden to another.
Ability to secure and share confidential research data
Choose a system that will secure your data and still enable sharing as the protocol and compliance require—easily—in a responsible and professional way. For instance, look for ease of integration among PIs, administrators, and your IRB board.
Complete SaaS system management
This includes backups, to security and upgrades, to integration with client identity management systems. Security alone is an ongoing challenge. For instance, there is a new report by the National Academies of Sciences, Engineering, and Medicine that offers “a framework for evaluating proposals to provide authorized government agencies with access to unencrypted versions of encrypted communications and other data.” Choose a compliance system that covers all aspects of regulatory and security upgrades.
Additional criteria to consider in your online research compliance software include:
- Capacity to support multiple IRBs and offer a customizable “tracking status” menu to enable administrators to assign a status to each protocol based on where it is in the review process
- Ease of use with student PIs and faculty co-PIs
- Capacity to easily submit amendments and revised consent forms as needed
- Facility to allow each IRB to review the arc of the process from PI submission to continuing reviews and unlimited adverse event reporting. As you know, under FDA regulations, concluding a study is a “change,” and requires “prompt reporting to the IRB of changes in a research activity.” Make sure your system enables your department to meet that key requirement.
- Adept at enabling customized, multi-part form submissions and continuing review reminders.
You and your PIs know your department’s software needs best. Be certain that your list of criteria is all-inclusive. When you’re ready, choose a new system that checks off each box.
Do your homework
Next, take the time now to avoid headaches down the road. Inquire with administrators from other research programs and institutions who have switched to online systems by asking these questions:
- What works well in their new system?
- What specifically has caused them headaches?
- How exactly does their online system actually shrink administrative burdens? Enhance the compliance process? Speed up productivity? Improve efficiency?
Our detailed feedback
At Axiom, we’ve also taken time to do some homework. Here is what we have discovered: it’s sometimes the little details which may have been overlooked that result in a series of submission frustrations for researchers and administrators:
- For example, in the area of time savings, we guarantee 99.95 percent up-time. Can you find a competitor to match that?
- Also, our time stamps work the way you need them to. The same cannot be said of our competitors
Here is a sample of other feedback our homework has uncovered:
- Some competitors fail to include: “smart forms” as part of the package, true e-signatures, a complete range of customized reports (e.g., which studies have been approved along with the staff for each one), customizable email alerts, quality communication alerts when a wrong button is clicked (e.g., submitting a new package vs. new project), and—surprisingly—no easy way for PIs to access all their recent packages
- Frequent system errors pop up in competitors’ systems. Add that to slow help desk reaction times while the date of submission gets closer, and you have a spike in tension along with wasted time
Knowing these details have been overlooked by our competitors, Axiom has resolved to eliminate them, preventing our customers from experiencing endless days of frustration and unproductiveness.
The Axiom Solution
The last thing you want is to trade one set of burdens for another.
Axiom wants to ensure that when your research program is ready to switch to an online research compliance software, you get it right the first time—with a system that facilitates your research submissions, reduces staff time, and clears compliance hurdles with ease.
Our services are designed, just like our products, to have your back: help when you need it, the way you need it. Also, you have a critical mission. We understand, and we’d be happy to help. Let us show you how.