The rationale for a Data Management and Biostatistics Core is to provide a standard procedure for the data capture, transfer, data entry and analysis. In addition, a single data management plan that applies to the three projects will provide more powerful and safety to the data. The approach outlined in this Core description will serve to further unify our already highly interactive research group and enhance communication between leaders of the three projects through the grant period. The data management software OpenClinica(R) Version 3.0 will be used as the standard system to all projects. Each subject seen at the Health Post in Corte de Pedra will undergo a clinical evaluation, which will be recorded in a specific CRF. An additional CRF will be used for laboratory results. All CRFs will be entered to the database by two computer programmers). Subjects will receive a unique specific number to identify the patient clinical information at the Health Post (Leishmaniasis Tegumentary Cutaneous Patient - LTCP). Subjects will receive bar code identification composed of a 10-digits and the LTCP number. The bar code for each subject will be printed on all study materials (CRFs and biological samples). Subjects'data in this database and other study materials will not include personal identifiers other than the LTCP number. The paper CRFs will contain the bar code identification and the LTCP number and will be kept in secure cabinets at the Coordinating Center. At the end of each visit, the CRFs for the subject seen at the Clinical Site will be placed in envelopes by the research team and will be delivered to the data entry person. Each envelope containing all CRFs completed in the visit will have a tracking form filled out by the research team. The signed tracking form will be kept as hard data in secure cabinets at the Coordinating Center. The transit of biological samples will also be tracked by a specific form which will be filled out by the research team and will contain description of type of sample collected and LTCP # for each sample.
Data management is critical in this research protocol because it will ensure that information once collected is and remains secure, interpretable and exploitable. This core will allow barriers and errors in projects be identified and rectified early. The data mamagement plan will provide the backbone for studies proposed in all projects, ensuring uniformity consistency of data collection, transfer entry and analysis.
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