The PRO Core will create guideline 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.
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.
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.
Phenotypes and Data Standards
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.
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 federal, FDA, and industry representatives, 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.
Provider-Health Systems Interactions
This core engages 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.
Electronic Health Records (EHR)
The EHR Core has created the NIH 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.