Evaluating Interactive Response Technology for Clinical Trials

This document is a guide focused on the evaluation of Interactive Response Technology (IRT) systems in clinical trials. It outlines the complexities faced by clinical trial sponsors and teams when deciding between purpose-built IRT solutions and IRT functionalities integrated into Electronic Data Capture (EDC) systems. The guide presents a framework to assist in this decision-making process, emphasizing the growing complexity of clinical trials, including increased protocol procedures and the need for real-time data management. It details the advantages of purpose-built IRT systems, such as their flexibility to adapt to changing trial requirements, real-time data access, and integration capabilities with other clinical trial management systems. The document also discusses specific scenarios where IRT as an add-on to EDC may be appropriate, highlighting the importance of assessing the trial's needs against the capabilities of available IRT solutions. Additionally, it identifies key factors to consider when evaluating IRT systems, ensuring that sponsors and clinical teams can make informed decisions.