IRT User Support: A Key Piece to the Clinical Trial Puzzle

Bob Weney

Defining IRT Support

Just like any other user support, in its most basic form IRT support helps users solve problems, providing guidance on how to use the system, and answering users’ questions. IRT support specifically assists with these requests for each clinical trial to manage patient enrollment, manage drug supply activities, and strictly control sensitive information such as treatment arm and medication assignments to maintain study blinding.

Who Uses IRT Support?

There are sponsor users that can largely be grouped into three areas: study management, supply chain management, and data management. However, this group’s support needs are typically not as urgent as the group that generates most of the requests. It’s site users who drive the bulk of support requests as they look for assistance with registering patient visits and working through challenges related to drug supply at their site.

What Are the Most Popular IRT Support Requests?

Many requests consist of the typical software support needs like managing account details: username, email address, password management. But it also extends into areas that are niche to a clinical trial like challenges with site supplies, data integrations, study management, and site data management.

Examples related to site supply can be understanding why the system may be displaying a message stating low or no inventory available or assisting with returning supplies to inventory. The goal of the IRT support team is to ensure uninterrupted supply to the site and ultimately the patients.

Requests regarding data integrations can include troubleshooting errors generated when data is passed between the IRT and another system as well as resending data to assist with overcoming the previous failures.

Study management related needs cover guidance to ensure the intended outcome is achieved when completing these study administration transactions within the system. A member of the sponsor’s team should be making the changes in the IRT as is expected by the regulatory agencies to demonstrate full control and awareness of their trial.

An IRT should allow users to modify some data directly in the system, for example, subject demographic information. Data management requests will come into play when data that is controlled due to blinding considerations and potential for use in driving stratification and/or medication assignment that needs to be updated. In these instances, IRT support is there to assist in making those changes without compromising the blind or the patient, when approved.

What Is IRT Support’s Role in Today’s Clinical Trial Environment?

Clinical trials become more nuanced and the industry continues to see turnover in front line roles like site investigators and trial managers, so user support is becoming a more critical part of the overall IRT solution. Whether it be providing guidance for users to get started using the system or direction to complete a specific transaction in the system, IRT support will be the first point of contact to ensure these team members are able to effectively and efficiently complete day-to-day trial activities. The IRT support team will also act as an extension of the sponsor’s team to assist with ensuring regulatory expectations are met in that Primary Investigators are always in control and aware of changes to their data. And, most importantly, IRT support teams’ job is finding a solution to a problem when a user is trying to ensure patients receive their medication correctly and on schedule.