Data Management Software for Clinical Trial Field Sites

In clinical research, many of the most important aspects of ensuring valid results hinge on the work of the Clinical Research Associates (CRAs) at field institutions. Many of the duties associated with the position of CRA are well-suited to computer-ization, yet most CRAs do not utilize or under utilize computers in their work. A key to valid clinical trial results is the accurate submission of data from the distributed clinical center to the research base. Patients must be followed carefully according to protocol, and accurate data must be submitted in a timely fashion. A data management computer system can help these efforts by keeping track of protocol requirements for individual patients, by ensuring that data is received by the research base in a timely manner through electronic submission, by increasing the accuracy of data entered on case report forms through on-line data entry with edit checks and table lookups, and by allowing various other time saving features such as automatic patient lists and accrual and other reports. Based on a prototype we have developed and used for over six years at our institution, we will develop a computer system for use in a variety of clinical centers.