The National Children’s Study recognizes the valuable contribution informatics play in many aspects of research studies, particularly those with the complexity and longevity seen with the Study. Our approach to informatics has been informed by several trends, including the use of open, modular, and flexible architecture, leveraging standards-based terminologies and transmission specifications, interoperability, transferability, and established development communities. As a general overview, the National Children’s Study has defined these terms as:
- Open Architecture: An architecture whose specifications are public, including officially approved standards as well as privately designed architectures whose specifications are made public by the designers.
- Modular: Built as a self-contained unit or set of units, each small enough in size to perform the functions of only one particular business area and do it well, with clearly defined input and output interfaces.
- Flexible: Able to meet the changing Study operational needs.
- Standards-based: Use of a broad range of industry technology standards and clinical and health research domain models and terminologies tailored for the National Children’s Study.
- Interoperable: Support for common interfaces and data exchange specifications.
- Transferable: Allow individual system modules to be utilized across Study operations without restriction, with the option for the user to update, enhance, and redistribute it. Does not require original developer and/or supplier assistance to configure or extend.
- Development Community: An open community of stakeholders, partners, and developers committed to collaborate and share resources and efforts to adapt and improve operations and functions.
Overall, the approach is flexible to support innovation, accommodate evolving technology, and extend functionality while continuing to ensure high levels of functionality and efficiencies from exposing programming code to large technical communities that can provide the needed testing, validation, and assurances of compliance, security, and usefulness. In our proposed informatics framework, there will be opportunities for the research community at large to better leverage the investments made and allow for use beyond the National Children’s Study.
The National Children’s Study used the initial phase of the Alternate Recruitment Strategy (ARS) Vanguard Study to engage in a “facilitated decentralization” approach whereby the National Children’s Study Program Office provided standardized guidance on the data to be collected and specifications on how the data was to be transmitted. This facilitated decentralization model offered distinct advantages over a completely centralized structure in that Study contractors were able to select or develop case management systems, data acquisition platforms, and as appropriate, data collection modalities to acquire the data. The model builds on contractor expertise with existing informatics systems and supports adaptation or development of new systems, with an emphasis on open-source, non-proprietary platforms.
More recently, based on the lessons learned, the National Children’s Study has begun a process of convergence whereby the number of information management systems (IMS) has been reduced to a limited number of solutions. The National Children’s Study is currently transitioning its IMS at many sites to one of a set of four systems that have been previously utilized at current Vanguard sites and found of interest for continued evolution and evaluation. These systems, for the most part, will use a hosted approach with local sites having direct access to their data through secure communications with the host provider. The four systems and the current contracted host provider are: