Data Management (DM) and Biostatistics Core (Core B) will be developed for this ICEMR to support research activities of all projects, providing a centralized DM and analysis system that will be used by all the Consortium members. The primary goal of Core B activities will be to ensure data security, confidentiality and quality as well as provide statistical support and facilitate communication among the specific project teams. These services represent a valuable integrative feature of this ICEMR program intended to meet the diverse needs of each project. We anticipate that this core will be beneficial and essential to the functioning and Integration of the various components of this program. Core B involves interdisciplinary scientific teams with key investigators from Guatemala, Panama, Colombia, Peru, the initial participating countries, and collaborators from Ecuador, Brazil, US and Europe. Close collaboration is expected to occur among all participants for the development of this DM system that will include data entry, checking and audit trials, tracking systems, security features, and personnel training. Data quality control will be provided by comparing report formats with data sources, assessing data for invalid or missing values, assuring that the data are in their intended operationalized format, and assessing for deviance in general data patterns. In addition this Core will give basis for the implementation of data sharing policies. A Website will be developed for Core B that will have data upload and download capabilities. This technological capability will facilitate high-level networking with our partner institutions. Statistical support will be an integral component of this Core that will have biostatisticians as key members. As the studies planned for this ICEMR are observational, epidemiological support will be a key issue for valid and efficient design of study protocols Those activities will include advice in study design and planning data analyses trying to minimize selection and information biases, for control of confounding factors, and to estimate sample sizes required for the testing of each hypothesis. Also as hierarchical levels of observation are proposed, database structure will be constructed accordingly. The Core will be directed by Dr Oscar Ramirez (MD/MPhll Epidemiology) with the support of a group of epidemiologists participating in the specific projects (1-3), statisticians and support staff. Drs, G. Carrasquilla, J. Mateus, R. Montoya, F.De la Hoz (Colombia), Llanos (Peru) and C. Guerra (Ecuador) are all epidemiologists with great experience in study design and DM. In addition Dr. O Gomez (US) will provide biostatistics advice. The close relationship of these DM-Core staff members provides a very academic and collaborative environment.

Public Health Relevance

This Core B will provide support to the research activities of all Projects and Cores, providing a centralized data management and analysis system, statistical support, training capacities and communication mechanisms to all the Consortium members.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1-AWA-M)
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Caucaseco Scientific Research Center
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