Table 1 Summary of fundamental research and infrastructural needs of OVCARE’s research community
From: From biobank and data silos into a data commons: convergence to support translational medicine
| Â | Fundamental research requirements |
1 | Generate efficiencies in data collection, storage and analysis to maximize utility of collected data |
2 | Limit errors in data handling and ensure reproducibility of research findings |
3 | Protect patients’ privacy and honor their consent |
4 | Optimize secondary and continuous use of data generated from research and clinical care |
5 | Facilitate the recruitment of patients in various clinical studies |
6 | Identify specimen from patients with specific clinical, molecular and genomic characteristics |
7 | Integration of medical and clinical data with molecular information to enable the discovery and testing of new associations and hypotheses towards translational research |
8 | Organize data towards a learning healthcare system where translation is bi-directional: Evidence-based research is used to inform practice, and the data generated during clinical care is in turn used to inform guidelines, generate hypotheses and trigger pragmatic trials |
| Â | Functional and infrastructural IT requirements |
1 | Allow batch data imports and exports |
2 | Facilitate validation of data entered to minimize errors (e.g. returning an error message when text is entered instead of a numeric value) |
3 | Easy-to-use and customizable user interfaces |
4 | Support both prospective and retrospective data collection mechanisms |
5 | Adapt to changing needs between studies and projects, as well as over time |
6 | Track biospecimen locations, usage and shipment to both local and offsite storage locations |
7 | Support multi-tenancy for the banking of biospecimens from distributed and diverse studies lead by different investigators interested in sharing resources |
8 | Adherence to best practices in privacy and security, such as, support for data encryption, audit trails on all user actions and data changes for regulatory compliance, configurable user privileges, role-based access control and adherence to federal regulations with respect to deidentification of specimen and tracking of consent |
9 | Support interoperability and integration with other institutions, systems, and data sources to facilitate data sharing |
10 | Potential to scale-up biospecimen and user capacity at no added cost |
11 | Stable and mature vendor and community support |