Collaboration Details

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Title of Collaborative Activity:

Harmonization of Various Common Data Models and Open Standards for Evidence Generation

Description of Collaborative Activity:

"This project is funded by the Office of the Secretary Patient Centered Outcomes Research Trust Fund for Data Infrastructure. This goal of this project is to facilitate the use of Real World Data (RWD) sources (e.g., claims, EHRs, registries, electronic Patient Reported Outcomes (ePRO)) to support evidence generation for regulatory and clinical decision making. This project will: (1) Develop common data architecture as the intermediary between various Common Data Models; (2) Create a sustainable, flexible, modifiable shared resource that can evolve over time with changing requirements; (3) Validate the common data architecture through a specific use case that would evaluate the safety of newly approved oncology drugs that help to allow the immune system to target cancers; and (4) Establish methods and develop processes, policies and governance for ongoing curation, maintenance, and sustainability of the common data architecture, building upon existing resources, standards, and tools."

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

2017

NIH Participating Institutes/Centers/Office of the Director:

NCATS, NCI, NLM

HHS Agency Collaborators on this Activity:

FDA, OS