Data and Information Management
· Understand the processes related to data management in clinical research;
· Master the principles of clinical research studies;
· Master the main activities involved in data management;
· Understand the changes in progress and also the expected changes in the field;
· Develop a data management plan in clinical research;
· Understand the principles of database collection and editing;
· Understand the specificities of electronic data collection;
· Articulate the various necessary infrastructure components for data collection.
Jorge Morais Mendes
Weekly - Available soon
Total - Available soon
Portuguese ou English
· Prokscha, S. (2011). Pra ctical Guide to Clinical Data Management, 3rd edition, Taylor & Francis, Boca Raton, Florida
· Rondel, R. K., Varley, S. A., Webb, C. F. (200) Clinical Data Management, 2nd edition, Wiley
· Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D. G., Newman, T. B. (2011). Designin g Clinical Research, 4th edition, Lippincott Williams & Wilkins.
The curricular unit is based on theoretical and pract ical classes, with content exposure (concepts, methodologies), presentation of case studies, methods discussion and problem solving exercises.
Final Exam (60%) + Project with discussion (40%)
The project is subject to the preparation and subm ission of a report and is discussed with the teacher. This project includes the design of a data management plan for a concrete clinical research problem.
To ensure approval it is necessary to achieve the minimum score of 9.5 in each of the eva luation components.
The curricular unit is organized in to five sections:
· Introduction to clinical data management;
· Electronic collection of data;
· Data quality and integrity;
· Quality audits.
Programs where the course is taught: