Beyond the audit: Taking quality and compliance to new heights with your IRT
By Matt Lowrie
Quality Assurance and Regulatory Compliance Manager
The IRT in your clinical Trial
IRT lives at the center of the eClinical world. It is often one of, if not, the first captures of subject screening, randomisation assignment, stratification, and drug dispensation. The IRT has become far more complex and involved than it was 20-30 years ago.
It is critical that the IRT is on the critical path for the trial, it is also critical that the IRT remains in alignment with the Clinical Trial Protocol. It’s best to remember those two key items when building the system. The IRT often interacts with other eClinical systems, which means the data flow should be looked at and it’s important to consider these facts and how you will maintain adherence to the various regulations not just during the trial, but during inspections and data reconciliations.
Selection and Design of the IRT
Given the expense of a clinical trial, and the spend for an IRT, getting the wrong one could destroy the total investment. To help you determine what and where you should be looking, there are several factors that need to be assessed. Part of that assessment is an audit; however, you should be creating a relationship that is ongoing and not supported by an every two-year visit.
Step 1 really should be the Vendor Selection. This is a fantastic opportunity to get yourself a demo of the system. Even if you have used it before, see what is new and what the system can offer you up front and out of the box. This is a chance to see if you can use what already exists to decrease costs, speed up timelines, and simplify your IRT.
Once completed I encourage everyone to open the dialogue with the IRT vendor across the stakeholders. This should absolutely include Quality and not just for scheduling a prequalification audit. The conversations should start around performance indicators, applicable documentation, support, and the best way to partner and maintain oversight of the IRT (or any eClinical system!). When we work with our partners, we make it clear- they are not alone in the trial. We are absolutely here to help and support along the way.
It is also important to create your Subject Matter (SME) team: who will provide input and approval to the UAT strategy document and UAT test scripts? Who will help execute the scripts? What design enhancements or changes are dealbreakers to closing the UAT Phase? Who needs to give final approval to move the system Live?
All of this before the system is ready to go live.
Support and Engagement
Once your study is live, it is imperative to maintain oversight on the trial. This may include regular data reviews, weekly meetings, or monitoring of the overall relationship. There are plenty of areas to consider, and luckily, you have a partner who does this across a large swath of other clients. Utilize their expertise and experience. I often see this made into something that is over complicated and resource heavy. It doesn’t need to be, the right people on the right topics can make this seamless and help fulfill your regulatory obligations regarding vendor/sponsor oversight.
It’s more than just a couple of meetings. There are aspects that should be considered such as the availability for day-to-day support, developers, and how the IRT will be supported during an inspection. This is where having a relationship that is open, and honest really helps the overall Quality and compliance of the system. Having a partner who is willing to share ideas and best practices is crucial for smooth and efficient trials.
At Almac, we support several inspections each month. The most successful of those are with our partners that we have a quick strategy meeting (30 minutes) to organize, understand scope, storyboard, and ensure all the necessary documentation and data is at the ready before the inspection even begins. Those 30 minutes save days, if not weeks, of churn, CAPAs, and updates to resolve findings.
The key principle overall is to realize it is indeed a partnership and a relationship. It needs to be treated as such with everyone involved utilizing their strengths and their partners’ strengths.
There are plenty of opportunities to demonstrate oversight, however, as an industry we need to move away from the outdated method of simply performing an audit. Audits are great as a verification, they are fantastic to help assess compliance and process, however, they cannot be used as the sole mechanism for oversight. You have a partner for your IRT who is an expert, utilize them. Ask them what they see as best practices, listen to their opinions on system design, ask about where they see potential risks or failures, and lean on them to identify how to best approach topics like User Acceptance Testing. Most importantly partner together.