HMS Clinical Research Database Gap Analysis

Client Situation
By 2004, the Harvard University Centers for AIDS Research (CFAR) program at Harvard Medical School (HMS) had seen its clinical research agenda grow rapidly in scope, magnitude, and complexity. This change resulted in a greater need for an enterprise-wide IT solution that would provide HMS CFAR with more efficient collaboration, centralized database capability, and seamless data exchange between participating institutions. HMS CFAR enlisted Digital Infuzion to assess the current clinical environment and determine the feasibility of a comprehensive IT solution. HMS CFAR was especially interested in the feasibility of an ongoing quality assurance program and a Harvard-wide Clinical Research Database.

The Solution: A Gap Analysis
Digital Infuzion began its assessment in February of 2004. Our experts visited numerous HMS CFAR institutions, held intensive knowledge acquisition (KA) sessions with key staff members, assessed current data quality assurance programs, evaluated existing workflows and data structures, and produced a Gap Analysis Report.

Investigation revealed that each institution’s varying technical capabilities and data collection methods made collaboration an enormous challenge. At the same time, the HMS CFAR institutions had a high level of collective IT preparedness. The essential groundwork for an enterprise-wide Clinical Research Database already existed at some of the institutes, providing a strong foundation for further development. And there was a high degree of support among HMS stakeholders for the desired database solution.

In light of these factors, Digital Infuzion’s Gap Analysis Report concluded that a Harvard-wide Clinical Research Database was feasible, and would provide the HMS institutions with improved knowledge management and collaboration solutions. For the next phase of the project, Digital Infuzion recommended that the HMS CFAR staff develop a set of critical success factors, clinical database specifications, data exchange guidelines, and a global library of common data elements on HIV.