A Database-driven Web-based System for Managing Research Protocol Change in a Multi-protocol Multi-institutional Setting

摘要

The H. Lee Moffitt Cancer Center & Research Institute serves as a Research Base for the NCI-funded Community Clinical Oncology Programs (CCOPs) and its Cancer Center affiliates. Through this program, community physicians participate in NCI-supported cancer control clinical trials. It is critical to provide the latest versions of research protocols, especially with respect to informed consents and current schemas and forms, to the geographically disparate community of health care providers and data managers participating in these trials. This paper describes a mechanism for managing post-activation changes in the research protocol life cycle. A database-driven secure web site has been developed to manage and communicate multiple, continuously changing protocols in a multi-institutional community.