New CRC systems streamline protocol initiation process, participant scheduling
The CCTS’s Clinical Research Center (CRC) has streamlined their protocol management systems to improve the transparency of clinical trial budgets and increase the efficiency of study participant scheduling, tracking and billing. The new, centralized system will make managing active clinical trials more convenient for the research team while improving clinic operations overall.
The CRC is unique in that it itself is a research project. While it provides services for researchers conducting clinical trials, its own research question is to determine if they are helping these researchers conduct high quality research. The CRC sees research protocols from all of the University of Illinois at Chicago’s health science colleges, including medicine, pharmacy, and many different specialties. While some protocols are short, others last several years.
Inefficiencies in protocol initiation and organization lead the CRC to rethink how they structured these processes. They decided to build a home-grown system, customized to the CRC but with a format that other clinical research centers could eventually use.
The first step was creating a tool that efficiently gathered all the required information for a protocol planning to utilize CRC services as well as maintaining a menu of services and their associated costs. PRIME (Protocol Request Information Management System) contains an inventory of all CRC resources including supplies, equipment and personnel and their associated costs. In a building block fashion, PRIME allows the CRC to combine these resources into services. For example, a blood draw requires 30 minutes of coordinator time, 30 minutes of a clinical room, one alcohol prep pad, one bandage, two gloves and so on.
PRIME inserts each service into a table organized by study visit and calculates the total cost per visit. It also projects total CRC costs over the course of the study based on the number of participants to be enrolled, including any discounts earned from different protocol funding awards. PRIME then generates a Memorandum of Understanding (MOU) using this table. The MOU explains the scope of the trial, what is needed for each study visit, and the associated costs. Once active, study participants are scheduled based on the availability of the resources described in the MOU.
“This allows for a very transparent approach to service cost construction,” says Lauren Castro, CRC Program Manager. “While the CRC’s goal is not to make a profit, we want to make sure that we are being good stewards of grant money and that we are sustainable.”
The CRC then took their process a step further and merged the protocol information generated by PRIME with their newest application: Clinical Research Online Scheduling System, Protocol, And Data Application (CROSSPAD).
“PRIME helps us initiate new protocols, and CROSSPAD helps us organize those protocols,” explained systems coordinator, Christian Gossett.
CROSSPAD was built upon the idea of resources and availability, and allows for a birds-eye view of the entire clinic operation from the computer screen. The system features real-time invoicing and an easy interface for the research team to schedule enrolled participants.
“If anything changes during the visit, we can add or deselect individual services. These are automatically entered into the report for the PI and costs are automatically adjusted- as opposed to the old system of manually entering all this information.”
CROSSPAD’s best feature may be the ability for the research team to schedule their own participants. Instead of multiple, time consuming communications between the CRC and study participants, study coordinators can now directly schedule CRC study visits via the web-based application. Because protocol details are automatically uploaded into the application, the system can determine if the necessary resources for the visit are available at a given date and time.
The CRC is actively using PRIME and in the process of granting CROSSPAD access to its health researchers. The CRC hopes to have CROSSPAD’s scheduling functionality fully accessible to all eligible investigators by June 2015.