Implementing a Clinical Research Management System: One Institution’s Successful Approach Following Previous Failures

摘要

Clinical research management systems (CRMSs) can facilitate research billing compliance and clinician awareness of study activities when integrated with practice management and electronic health record systems. However, adoption of CRMSs remains low, and optimal approaches to implementation are unknown. This case report describes one institution’s successful approach to organization, technology, and workflow for CRMS implementation following previous failures. Critical factors for CRMS success included organizational commitment to clinical research, a dedicated research information technology unit, integration of research data across disparate systems, and centralized system usage workflows. In contrast, previous failed approaches at the institution lacked a mandate and mechanism for change, received support as a business rather than research activity, maintained data in separate systems, and relied on inconsistent distributed system usage workflows. To our knowledge, this case report is the first to describe CRMS implementation success and failures, which can assist practitioners and academic evaluators.