Informatics Core Services

Database Services

Informatics Core staff develop databases for investigator initiated studies. Databases have been traditionally implemented using MS Access. In addition, a small number of web-based database applications have been developed as well. However, the Informatics Core is re-thinking the way these technologies are utilized in setting up database applications. While MS Access is efficient for creating simple database applications, it becomes cumbersome as the complexity of the database design increases, which results in high development costs and delayed application rollout.

In addition, MS Access does not necessarily have the security features necessary for insuring compliance with HIPAA and other federally-mandates data security regulations. As an alternative, the Informatic Core has partnered with Akaza Research (Cambridge, MA) to develop a software application that will facilitate the creation of secure, HIPAA-compliant web-based applications simply and transparently. The resulting product, which is in the beta phase, has been named OpenClinica.

OpenClinica is an integrated software platform for web-based data submission, management and retrieval of phenotypic datasets from multi-site, multi-project clinical research studies. Akaza Research initially developed Pheno, as it was initially called, in conjunction with investigators at the Psychiatric and Neurodevelopmental Genetics Unit at Massachusetts General Hospital (MGH) and the Broad Institute (formerly the Whitehead Institute/MIT Center for Genome Research). OpenClinica dynamically generates web-based interfaces for the clinical instruments defined within a project, while implementing the validation logic specified. It provides investigators with intuitive web-based workflows to submit, query and export datasets, manage multi-site projects and administer project-specific user roles and privileges. OpenClinica serves as a centralized data repository for all GCRC studies. Each investigator can setup his/her own research projects, define custom clinical assessment instruments, and manage policies for his/her own studies in diverse clinical research domains. OpenClinica implements a robust security model, advanced data integrity, and comprehensive auditing. It fosters interoperability and cooperation among investigators by facilitating data exchange using standardized formats.

Key Features:

• Centralized clinical data repository to securely manage data while providing distributed web-based access for collaborative research.
• Organization and management of clinical research along multiple hierarchical studies, each with its own set of authorized users, protocols, patient cohorts, CRFs, and saved queries; the system supports sharing resources across projects in a secure and transparent manner.
• Dynamic generation of web-based case report forms (CRFS) for clinical assessment instruments from user-defined clinical parameters, protocols and validation logic.
• Double Data Entry capabilities for clinical data to ensure accuracy when transcribing data from paper forms.
• Intuitive workflows and user interfaces integrated within the context of a familiar web-based environment; this improves access and minimizes the need for dedicated training.
• Extensive interfaces for data query and retrieval across projects, individuals and phenotypic parameters, with export of datasets in standardized formats for statistical analysis in SAS/SPSS.
• Compliance with HIPAA privacy and security guidelines including use of hierarchical user roles and privileges within projects, SSL web access, de-identification and encryption of Protected Health Information (PHI), and auditing of data updates/access.
• Runs on the Java J2EE and Struts framework, with an Oracle or PostgreSQL RDBMS (relational database management system) and data import/export tools. This architecture provides a secure, robust and extensible system for managing multiple clinical research studies within a centralized repository. Clinical data can be securely accessed within a GCRC intranet or across research sites distributed worldwide.