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

The Safely Held Electronic Data Platform (SHED) provides OnCore® Enterprise Research, a data management tool allowing for longitudinal tracking of study  subjects (including disease profiles and outcomes) and storage of versioned IRB protocols, subject consents, clinical findings (including images) and pedigree-formatted family data. LabmatrixTM  provides the capability for complete biospecimen tracking (annotations, locations, chains of custody, barcodes), cell and cell lines annotation, and reporting (research-oriented + administrative).  Oracle Application Express (APEX) is a framework for designing custom interactive applications tailored to the specific needs of a project.  These three offerings together 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.