What is the SHED?
The ICB SHED -- a securely held data repository -- is a collection of tools for managing and analyzing human subjects studies that contain individually identifying data elements or other personal health information (PHI). Typically used for ascertained studies, the ICB SHED provides the ability to collect data on study participants, store and query the data, and perform statistical analyses, all done without removing the data from a secure space. The ICB SHED can manage studies from any institution in the Cleveland area.
What types of data can go into the SHED?
The SHED provides tools for managing study subject annotations, clinical data (including clinical trials), biospecimens, and a variety of -omics data. These studies are typically IRB approved, are directly ascertained by investigators who also collect primary data on study subjects, and retain patient identifiers and personal information. The SHED does not manage Federally Regulated studies (such as clinical trials that report to the FDA) -- these studies are referred to Carolyn Apperson-Hansen and the Clinical and Translational Science Center (CTSC).
What tools are available in the SHED for managing data?
Biospecimen and Clinical data management is provided by BioFortis Labmatrix. Overall study management is supported by Forte Research Systems OnCore Enterprise. If there are special requirements for your study, we also support Oracle Application Express (APEX) for custom development to suit your needs.
How do I get my study data into the SHED?
The ICB provides a required training/on-boarding session that will help you to establish your study data within the Data SHED. Our staff and technologists will assist by creating input forms and other options for data capture, and customize the environment for your specific study requirements. Existing study data can be batch loaded into SHED tools, and new data elements can be entered into the system using web-based portals (with two-factor identification for security purposes).
How do I get my data out to analyze it?
A key point of weakness in data security is the transfer of data. When data files are emailed or stored on unsecured desktop computers, laptops, or thumb-drives, accidental data security breaches are far more likely. A key advantage to using the SHED is that the data never leaves the secure environment. Investigators can interact with their study data in a limited fashion with web-enabled query and reporting applications, like Qiagram. More sophisticated analyses can be performed within a Virtual Research Data Center -- a Virtual Desktop instance that provides any functionality and software available within Windows or Linux operating systems. This flexible environment can be customized for your specific needs. We currently do not support large-scale analytics (such as those requiring computing clusters).
Can I control who accesses my data?
In consultation with study investigators, ICB staff and technologists will implement a security and operations program that provides multiple layers of data security and access control -- these types of features are required to make this data environment HIPPA compliant. By crafting a custom plan, the ICB will ensure that every member of your research team has access to the data that is appropriate to their role in the project.
What types of biomarker data can I deposit and store?
The SHED tools support a variety of biological data types. Sequence-derived biomarkers including RNA-seq, genomic variation...
What level of compliance does the Data SHED offer?
The SHED is a Health Insurance Portability and Accountability Act (HIPPA) compliant environment, with some Federal Information Security Management Act (FISMA) controls.