Some research studies require detailed interaction with study participants, such as tracking medical outcomes for clinical trials, or re-contacting participants at a later date for follow-up. As a result, investigators may need to securely store personal health information (PHI), such as names, addresses, and birth-dates. Management of these types of studies require secure data management at each step of the process -- data acquisition, management, and analysis – and this must be done efficiently and in compliance with all appropriate regulations regarding the protection of PHI.
The Safely Held Electronic Data Platform (SHED) provides OnCore® Enterprise Research, a data management tools allowing for customized data structures, 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) is also provided.
Case Western Reserve’s University Technology (Utech) developed, manages, and maintains a Secure Research Environment (SRE) for exactly these purposes. The SRE uses standardized operating procedures, rigid access control, auditing and encryption procedures to minimize risk to study data. Within the SRE, the Institute for Computational Biology has deployed the SHED for the explicit purpose of managing scientific studies containing PHI, and is HIPPA, FISMA, and SANS/ISO compliant.