Project management model for clinical research

Abstract

Objective: To develop a model for the management of research projects, in public-private and private scenarios. Methods: Prospective cross-sectional study with the application of a specific questionnaire for research centers in the country. This instrument evaluated the practical application of the 10 areas of Project Management Body of Knowledge (PMBOK®) (management of integration, scope, time, costs, quality, human resources, communications, risks, acquisitions and stakeholders) of in relation to the daily practice of clinical research in the country’s research centers. Results: Of the 195 eligible research centers, 55 centers answered the complete questionnaire. The professional with the position of project manager does not exist in 37 active centers (67.3%), there is no project management office (PMO) in 41 centers (74.5%). The control of expenses and revenues is carried out by 50 centers (90.9%), however, 28 (50.9%) carry out an evaluation of the profitability. Regarding quality management, 28 (50.9%) did not have quality parameters implanted and 11 (40.7%) did not perform internal audit. Communication failures are present in 48 (87.2%) centers. Based on the evaluation of the practical application of the 10 knowledge areas of the PMBOK® Guide, the project management model was developed with applicability to clinical research centers. Conclusions: It is possible that the centers have a better definition of the scope of each project, the costs and deadlines have a low margin of variability, a good communication between the parties is established and the economic impact of the management can be recognized