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Comprehensive Data Management and Reporting for Clinical Research Collaboration

This document outlines the essential components of effective data reporting and management for co-investigators in clinical research. It addresses multi-site studies, integration with platforms such as CIBMTR and clinicaltrials.gov, as well as compliance with regulatory bodies like the FDA and NIH. Emphasizing the use of SAS, flat files, and the MIX platform, it encompasses data profiling, QA standards, and governance policies such as HIPAA compliance. The framework supports efficient data analysis, daily refresh protocols, and shared transformations for enhanced research collaboration and decision-making.

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Comprehensive Data Management and Reporting for Clinical Research Collaboration

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  1. Data Reporting to: • Co-Investigators (local or multi-site studies) • CIBMTR/scTOD • Clinicaltrials.gov • CTRP • FDA • NIH/NCI • Insurance reports • Industry reports • Etc. Data sets SAS, flat file, etc. MIX Platform PI Data Management Applications Reports Data Analysis & Reporting PI Clinical Dashboard • MIX Data Management • Daily refresh • Exact copies of data • Used for reporting, analytics • Data profiling for QA • Reference Data Sets, Xref Tables • Common or shared transformations • Data Standards (caDSR CDE etc) • Data Rights Management • Data Governance Policies • Data Security (HIPAA) Data Repository Researcher and Biostatisticians Data Reporting Environment Integration & Transformation caDSR Data Management HL7 Legacy Databases Staging Area Fairview, UMP, etc. Information Exchange Data Entry Applications Clinical (EMR, LAB) Research Lab Regulatory Product Admin Financial Registry Other PI Applications Eclipse Data Systems

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