The CICB SHED provides secure storage of clinical data for research studies

The Safely Held Electronic Data – SHED – system is a standardized and integrated database platform that provides unified management of data from multiple sources. The SHED is designed around complementary systems that are enhanced with custom software tools.

  • Oncore®: This database system, based in Oracle, provides the auditability and process visibility essential to the management of clinical trials and human subjects cancer research. Oncore® has particularly strong applications for safely managing personally identifiable information and tracking these data over multiple distinct interactions, which may include longitudinal visits or laboratory data being captured at different times.  
  • Labmatrix™: This database system supports the management of laboratory and other research-derived data. Labmatrix™ has multiple system-level interface options to facilitate the exchange of all appropriate patient and biospecimen data. Qiagram is a graphical user interface that can query and integrate data across Oncore® and Labmatrix™.  Qiagram allows a user to develop and execute queries across all the data elements, easily integrating across clinical, neuropathological, demographic, biomarker, imaging, and genomic data.
  • Oracle Application Express (APEX) is a framework for designing custom interactive applications tailored to the specific needs of a project.

These three offerings address a wide range of logistic support and data management tasks.

 

The SHED provides study management that is

HIPPA Compliant

HIPAA, the Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data. Any individual who deals with protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed.

FISMA Compliant

FISMA is one of the most important regulations for federal data security standards and guidelines -- it was introduced to reduce the security risk to federal information and data. FISMA establishes a set of guidelines and security standards for federal agencies and any individuals that are involved in a contractual relationship with the government.

SANS/ISO Compliant

ISO IEC 17799 2005 is the "Code of Practice for Information Security Management," and is the most widely accepted standard throughout the world.  The SANS checklist provides precise audit checks that can be performed on the organization's infrastructures, and used in conjunction with the standard for Information Security management.

107,376 Specimens
43 Total Projects
329 SHED Users

ICB SHED services are in use across Cleveland

The SHED is a housed within a Secure Research Environment (SRE) developed and managed by Case Western Reserve’s University Technology (Utech).  The SRE uses standardized operating procedures, rigid access control, auditing and encryption procedures to minimize risk to study data.