The Clinical Research Improvement in Systems and Processes (CRISP) project was initiated in January 2015 with the goals to reduce the study start-up turnaround time to not more than 100 days and meeting industry expectation, increasing satisfaction, and meeting target enrollment goals. The project has institutional priority and has benefited greatly from cross grounds collaboration.
Process boundaries and scope
The study management process has three components: “Start-up”, “Conduct”, and “Close-out”. The initial focus and scope of this project is on improving and automating the “Start-up” process. The starting point of this project is when the investigator has a protocol design or a full length clinical research protocol. The “start-up” process ends when the study is approved and ready to enroll subjects. The project assumption is that the funding source is secured prior to beginning the process. All human research studies going through the IRB-HSR are included in the scope of the project. The process includes submission to and approval by non-IRB Regulatory committees, IRB, as well as review and set-up for budget, billing, PTAO, ancillary services and Epic, and contract negotiation and execution. Some of the start-up components may be identified as ‘not applicable’ depending on the study type.
The project team completed a rigorous review of the current process, used Lean methodology to identify and eliminate any activities that did not add value to the process, and created a new proposed future state. In January 2016, the project team began development of a new workflow application to support the start-up process for health sciences research. The improved and automated process will add a significant strategic and tactical value to the UVA Health System, and the University as a whole.
The application will support multiple components of the start-up, interfacing with different systems and creating electronic communication with various functions. The systems’ interfaces will support necessary data flow (in some cases bidirectional) between the new workflow, ResearchUVa, IRB Protocol Builder, IRB Online, and a Clinical Trials Management System (OnCore – utilized in the Cancer Center). The workflow system’s functionality will include: a single data entry for a large number of common data points across various systems, electronic submission to multiple functions, smart and proactive validations, automated notifications, electronic signatures, auto-generation of documents, and reporting. The new automated process will allow everyone involved in the study start-up to realize increased efficiency, visibility, and accuracy.