Lawrence R. Tarbox, PhD, Washington University in St. Louis School of Medicine; Fred Prior, PhD; Stephen M. Moore; Ralph Moulton; David Maffitt; Matthew Kelsey

The Center for Clinical Imaging Research (CCIR) is a suite of six high end scanners dedicated to research use and sited in the middle of Barnes Jewish Hospital. Being too large for ad hoc or manual processes, we have created a unique informatics infrastructure for CCIR to cope with the challenges of managing research imaging, which are quite distinct from routine clinical imaging.

Although an informatics infrastructure for a dedicated research imaging center may have many similarities with the informatics infrastructure for a clinical imaging center, it must also take into account certain differences. Research scan protocols often differ dramatically from the standard protocols used in a clinical department, yet they must be managed to assure consistent imaging throughout the course of a research study. The ordering and scheduling of exams can be quite different between research and clinical centers. Care must be taken to produce de-identified data sets for research use, while still allowing fully identified data sets to circulate back into the clinical environment when appropriate. Patient identifier management must take into account subject identifiers assigned by external trial coordinating centers, as well as internal identifiers used for daily work and for creating an anonymized longitudinal record for data mining purposes of scans done on a particular subject across multiple trials. Strict separation must be maintained between the billing of grants for pure research scans and the billing of insurance companies for clinically oriented scans, even though both may be done in the same visit, possibly on the same equipment. And access controls for a research data repository for protecting a researcher's work, while still allowing for the sharing and mining of data, presents a set of problems quite distinct from those of a clinical data archive.

We have been addressing the challenges of managing the CCIR through an informatics infrastructure that blends a commercial clinical RIS system with custom-built and open-source software to handle the idiosyncrasies of research imaging. Wherever possible we have used standard interfaces, such as those described in IHE Scheduled Workflow Profile (www.ihe.net), to maximize the reuse of codes and minimize the number of changes needed to existing software, though at times some creativity has been required in the way messages and fields are used to be able to link pieces of the research record together. We have added a research protocol management system, along with front ends, for participant registration and order management to address the distinct needs of a research imaging center that were not served by the clinical RIS. We have also tied these front end systems to an enterprise-wide clinical trial management system using RESTful interfaces which, in turn, is connected to the university’s electronic IRB system. On the back end we have added a data collection and distribution system that, using information from the front end systems, ensures that data sets with appropriate identifiers get automatically routed to configured destinations. A back-end repository based on the XNAT software (www.xnat.org) provides a research-project-oriented view into the data and controls the access to and sharing of data among researchers. That back end repository will be indexed in a variety of ways to facilitate data mining. All of these subsystems are tied together through a web-based portal that provides role-specific access to system functions. As we have been rolling out this software, we have often needed to change directions to meet shifting user needs. Hence a flexible architecture and development process was needed.

The informatics infrastructure that we have created for CCIR meets many of the challenges of managing a research imaging center, while still maintaining synergy with the clinical world. As we gain more experience with it, the systems will continue to evolve to better meet the needs of our user community and improve the operations of our research imaging center.