The Data Management Core (DMC) will serve as a central resource for data management, project coordination, and publication review for the Columbia Center for Child Environmental Health (CCCEH) research program, as described in this Center grant application. The Core will serve as a central repository for all individual-level data, and will generate data files required for statistical analysis in each project. The three proposed projects build on the existing cohort of 727 children and mothers and the central database containing all exposure, outcome and biospecimen data collected on these subjects?a data resource that has been developed during the first 16 years of the Center?s continuous funding. The fundamental strategy of the Data Core in the proposed funding period is to continue to deploy and further develop the technological resources and functionality that have supported the existing databasing and coordinating infrastructure for the Center. The DMC will serve the P50 by pursuing the following specific aims: 1) Provide the centralized resource for all data management needs of the CCCEH projects and Cores, including database design, implementation, data entry, and data retrieval for statistical analysis. 2) Ensure that all subject-level data required for the primary and secondary analyses described in each aim of this proposal are a) transmitted and incorporated into the central data repository in a timely manner; b) fully documented; c) vetted and cleaned; d) available in response to approved data requests. 3) Design and implement data capture systems to a) enter questionnaire data from paper forms; b) acquire and integrate electronically-generated laboratory data, including key subject-level indicators and biomarkers from all planned laboratory analyses, including both biomarkers and imaging. 4) Develop and maintain a comprehensive, secure and interactive project-coordination system, allowing project coordinators to update subject contact information, manage subject visit scheduling, and monitor acquisition of each type of interview and biomarker data. 5) Implement procedures to maintain the highest standards of data quality and data security; data will be maintained and provided to internal investigators and external collaborators in a manner consistent with HIPAA and other federal regulations, and with all applicable Columbia University policies. 6) Manage the data request process and fully document all approved data requests. Establish a repository to a) store and document all subject-level data and programming required replicate the results reported in each Center publication; b) make data available to collaborators through Data Use Agreements and other appropriate methods, as specified in the data sharing plan described in this proposal. The DMC employs a unique databasing protocol to speed statistical analysis, in which all data fields are self-documenting, including variable labels, value labels for categorical variables and missing value indicators; these attributes are automatically transferred to statistical system files, so that SAS, SPSS and other statistical files are self-explanatory and do not require the use of external codebooks.
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