Data and Information Management
Objectives
· 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.
General characterization
Code
191012
Credits
6
Responsible teacher
Prof. Doutor Pedro Simões Coelho (IMS)
Hours
Weekly - Available soon
Total - Available soon
Teaching language
Portuguese ou English
Prerequisites
Bibliography
· 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.
Teaching method
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.
Evaluation method
Final Exam (60%) and 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.
Subject matter
The curricular unit is organized in to five sections:
· Introduction to clinical data management;
· Electronic collection of data;
· Data quality and integrity;
· Quality audits.