The Collaboratory comprises seven cores and their corresponding working groups:
Electronic Health Records (EHR)
The EHR Core has created the NIH Collaboratory Distributed Research Network to enable distributed remote analysis of research datasets across health systems and act as the key repository for the tools and infrastructure we create to leverage EHRs to support clinical research across multiple health systems.
Phenotypes, Data Standards, and Data Quality
This core will develop phenotype definitions, identify data validation best practices, store generalizable definitions and best practices in an accessible format, and use standards organizations to move these measures into practice.
The PRO Core will create guidelines and define best practices with respect to 1) selecting, compiling, and curating the most appropriate PRO measures (and stimulating the development of new instruments when new solutions are needed); 2) providing guidance for the creation efficient, high-quality PRO data collection systems compatible with EHRs and registries; and 3) conducting statistical analyses of PRO endpoints.
Health Care Systems Interactions
This core will engage those involved in delivery systems to participate in research, facilitate the design and conduct of research protocols attractive to practitioners, lower administrative barriers, and communicate results to all parties.
The Regulatory/Ethics Core will develop policies and practices to provide a framework for the conduct of health systems research in an ethical manner and in compliance with federal and state regulations. The core will also identify areas of uncertainty and aid the Collaboratory and its network in resolving uncertainty through dialogue or empirical research when needed.
Biostatistics and Study Design
This core will create initial guidance and technical documents regarding study design and biostatistical issues; identify new issues and add
additional content and case studies; and ally with NIH collaborators, UH2
and UH3 investigators, and academic institutions to gather additional input
into key methodological issues.
This core will establish an external stakeholder advisory group as an integral part of the structure of the Collaboratory. The advisory group will include IRB Members, patient and consumer representatives, CTSA Consortium investigators, representatives from government, FDA, and industry, clinicians and professional societies, private and public health insurers/payers, clinical guideline developers, external healthcare systems, and others from among the Collaboratory's network organizations.