Current research requires the collection, generation, management, analysis, visualization and interpretation of large, varied, and detailed data sets. These data sets typically include demographic and family history, numerous clinical measures, biomarkers, imaging, genetic, and longitudinal follow-up. All of these data must be tracked, quality controlled, and safely stored in a manner that allows easy access for analysis and interpretation.
Included in the Institute’s resources and services are state-of-the-art hardware and software infrastructure, as well as professional support for data management, storage, analysis, and reporting.
Secure Research Environment (SRE)
The SRE is a collaboration between the Institute and Case Western Reserve University’s Technology office (UTech). We manage and maintain a secure environment for computational activities that serve the Cleveland research community.
The SRE is governed by a risk-assessment security program with controls that meet recommendations or requirements of regulatory and information security standards (including HIPAA security, FISMA, and SANS/ISO recommendations). These secure data management, monitoring, and control capabilities ensure that research teams can appropriately acquire, manage, and analyze research data efficiently, accurately, and with trustworthiness.
SHED: Safely Held Electronic Data
The SHED is a standardized and integrated database platform directed by the Institute and housed within the Secure Research Environment (SRE). The SHED provides unified management of data from clinical trials and human subjects research studies, as well as biomaterial and imaging data. It is designed around complementary systems – OnCore® and Labmatrix™ – that are enhanced with other custom software tools. Read more here.
Secure storage of extremely large data sets
Certain data types (particularly images and DNA array and sequence data) generate extremely large files that are not easily managed within standard relational databases. These data are stored separately in an indexed, controlled access, file format within the SRE.
Only location links to these files are stored within the SHED. A web-based portal can enable access to specific projects’ locations within the SHED for data entry, data management, and data extraction. These uses require two-factor authentication, to meet the secure environment requirements.
Data Management and Statistics Consulting and Implementation for Regional Consortia
The Institute serves as the Data Management and Statistics Core for the Cleveland Alzheimer’s Disease Research Center (CADRC), one of 31 NIH-funded consortia. We are responsible for maintaining a secure research environment, interactivity with all other CADRC Cores, and biostatistical and data analysis support. Read more here.
Integration with National Data Bases
NIH-funded research includes a requirement that data be collected in specific formats and then be integrated with national databases that are accessible to the research community. Read more here.
Mark Beno, MSM, Senior Director of Strategic Operations