OpportunityTitle: Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o   Hispanic-serving Institutionso   Historically Black Colleges and Universities (HBCUs)o   Tribally Controlled Colleges and Universities (TCCUs)o   Alaska Native and Native Hawaiian Serving Institutionso   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsForeign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Description: Data concepts (not just the information but the underlying definition of its meaning) between many different sources of real-world data (RWD) (e.g., EHRs, Claims, and digital health technologies) as well as those used in clinical research and regulatory submissions are almost always similar but not identical. This difference requires mapping and transforming data between RWD and clinical research use to rely heavily on human interpretation and is an obstacle to developing a fully reliable computer-driven approach. This request for applications is aimed at defining the elemental components of RWD in a way that may support future computable approaches to defining what is currently only implied by definitions of data elements or business practices to facilitate standardization for regulatory submissions.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592