A "three-plus-one" evaluation model for clinical research management.

Clinical research management (CRM) is a critical resource for the management of clinical trials and it requires proper evaluation. This article advances a model of evaluation that has three local levels, plus one global level, for evaluating the value of CRM. The primary level for evaluation is that of the study or processes level. The managerial or aggregate level concerns management of the portfolio of trials under the control of the CRM office. The third, often overlooked level of evaluation, is the strategic level, whose goal is encapsulated in the phrase, "doing the right trials, while doing trials right." The global ("plus one") evaluation level concerns the need to evaluate the ever-increasing number of multi-institutional and multinational studies. As there are host of evaluation metrics, this article provides representative examples of metrics at each level and provides methods that can aid in the selecting appropriate metrics for an organization.