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Comprehensive Data Management and Reporting Framework for Oncology Research

This document outlines the organizational support structure and data governance framework for managing oncology business layer datasets, including disease registries and regulatory reporting. It highlights the integration of various systems such as CA Tissue, I2B2, and clinical trial management systems to ensure data consistency and security in compliance with HIPAA regulations. Key components include executive oversight, common infrastructure, data rights management, and aligned policies and procedures. Enhanced reporting capabilities for co-investigators and external collaborators are also discussed, ensuring seamless data exchange and compliance with industry standards.

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Comprehensive Data Management and Reporting Framework for Oncology Research

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  1. AHC-IS Organizational Support Structure Oncology Business Layer Disease Registries PI Dashboard Regulatory Reports Biostats Datasets Etc. AHC-IS Executive Committee • Common • Infrastructure • OS • DBMS • Architecture • Data Rights • Data Governance • Policies & Procedures • Standards • Shared Tools • & Applications • CA Tissue • Shrine • I2B2 • CTMS CDR • Oversight • Governance UMP External Collaborators Fairview AHC-IS maintained Common Data Exchange Platform EMR DATA AHC-IS Research Application Development Bus Unit 1 Bus Unit 2 Bus Unit 3 Bus Unit 4 Biomedical Health Informatics (BMHI) Eclipse Data Systems, Inc.

  2. Data Reporting to: • Co-Investigators (local or multi-site studies) • CIBMTR/scTOD • Clinicaltrials.gov • CTRP • FDA • NIH/NCI • Insurance reports • Industry reports • Etc. Oncology Business Layer Data sets SAS, flat file, etc. PI Research Outcomes Applications Reports Data Analysis & Reporting PI Clinical Dashboard • OBL 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) Cancer specific Researcher and Biostatisticians Data Analysis Integration & Transformation caDSR Data Management HL7, Data Extracts Legacy Databases Staging Area Fairview, UMP, etc. AGNIS NMDP Legacy Feed until CDR is implemented OnCore LIMS Research Lab Regulatory MCT TASC BMT Other PI Applications Data Entry Applications Eclipse Data Systems, Inc.

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