RFA-OD-20-019: Emergency Awards: RADx-rad Data Coordination Center (DCC) (U24 Clinical Trial Not Allowed)
Internal Deadline: First-come, first-served.
LOI: August 31, 2020
External Deadline: September 30, 2020
Award Information: Type: Cooperative Agreement
Funds Available and Anticipated Number of Awards: NIH intends to commit up to $ 6.2 Million in FY 2021 to fund one award.
Who May Serve as PI: Standard NIH eligibility requirements.
Process for Limited Submissions: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://research.usc.edu/usc-grants/.
Materials to submit include:
(1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
(2) CV – (5 pages maximum)
Purpose: NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) Initiative.
Specifically, this FOA seeks to fund a single cooperative agreement for a RADx-rad Data Coordination Center (DCC) to serve as a communication center and data hub for RADx-rad awardees.
Specific Research Objectives:
- Administration and Coordination – The administrative functions include facilitating the work of the RADx-rad research awardees and NIH scientific staff in the overall program management of the initiative. Activities should include, but are not limited to:
- Leadership and project management for the administrative and data coordinating functions
- Establish and manage committees and communication mechanisms that bring together the RADx-rad PIs and NIH Program and Science officers; establish a DCC Steering Committee to develop policies governing matters such as (e.g., authorship, communications, data sharing, etc.); establish a RADx-rad Governance Committee); establish a Data Safety Monitoring Board, and provide logistics and management support, such as organizing meetings, and maintaining documentation
- Develop an organizational and administrative structure to promote communication, provide technical assistance, and facilitate interaction across the RADx-rad awardees, including maintaining a RADx-rad directory and a web-portal to assist with information sharing
- Establish and implement an evaluation plan for the RADx-rad program, including a logic model, evaluation data collection, processes to specify, track, and assess testing milestones, and metrics of success
- Prepare and distribute regular reports to RADx-rad awardees, NIH and regulatory agencies, including progress and data summaries; participant demographics, enrollment and COVID-19 testing data; Data Safety and Monitoring Board reports, interim findings, and scientific outputs such as publications and presentations
- Implement a DCC data management model (i.e., RADx-rad hub) that serves as a repository for data from the RADx-rad awardees (i.e., RADx-rad spokes), and that will also provide appropriately deidentified data for inclusion in larger NIH data integration model.
- Bring awardees together to reach consensus around appropriate data standard, CDEs and data sharing methods for management of diverse data sets (e.g., qualitative, quantitative, EHR, geospatial, healthcare systems and settings, implementation data types), such that preparation of de-identified data for public use is supported
- Data Collection, Integration and Sharing – The DCC will manage data collection, integration, and sharing for the RADx-rad awardees. It will apply appropriate biomedical informatics and data science approaches for managing a broad range of data types, including identifying approaches for harmonizing and merging data where feasible, working with latent variable structures, and other strategies to create a data ecosystem for the RADx-rad consortia . The DCC should also have expertise in the design and analytic methods appropriate for studies that test and evaluate technologies for human use. Activities must include at least the following:
- Build a DCC data management capability (i.e., RADx-rad hub) that serves as a repository for data from awardee projects (i.e., RADx-rad spokes), and that will also link to the NIH data hub in the larger NIH data integration framework.
- Facilitate data standardization, harmonization, integration, and analysis across RADx-rad projects
- Provide expertise and assistance on data sharing, IRB and other human subject issues, including cross-consortium human subjects consent and assent procedures
- Document and recommend standards for describing data sources, common data elements, vocabularies, storage and integration methods that support FAIR data use
- Provide consultation on use of standards, common data elements, common data models taking into account existing standards and resources including:
- Data Harmonization for Social Determinants of Health via the PhenX Toolkit: (phenxtoolkit.org)
- NIH Common Data Elements (CDE) Repository https://cde.nlm.nih.gov/
- Use of trans-NIH COVID-19 survey items via the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/]
- Use of OMOP models (https://www.ohdsi.org/data-standardization/the-common-data-model/)[B when applicable
- Implementation of the schemas proposed under the ABOUT ML effort (“Annotation and benchmarking on understanding and transparency for machine learning lifecycles”; available at https://www.partnershiponai.org/about-ml/
- Develop agreements about the structure and content to enable sharing and aggregation required by multiple projects. The use of standard vocabularies, CDEs and data dictionaries will support joint analyses and sharing.
- Maintain up-to-date knowledge and expertise on new COVID-19 related diagnostics and provide frequent communication to the RADx-rad awardees about new testing approaches, FDA-authorization or approval status, testing supply availability, and considerations for the implementation of emerging testing protocols
- Communicate and provide technical assistance, as needed to encourage adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf), where applicable and within scope.
- Provide support for adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf)- which includes three NLM supported vocabulary standard for codes (and names) for drugs, tests diagnoses, symptoms, some social determinants of health, some psychologic scores and all of the Medicare/Medicaid assessments.
- Data Management and Use – The RADx-rad DCC will provide expertise and disseminate information on emerging and new innovations on COVID-19 diagnostics and test modalities.
- Establish a secured, centralized, user-friendly data warehouse for RADx-rad that can accept individual participant data including unique participant IDs but does not contain personal identifiers. The data resource should be designed to promote and leverage standardization of data collection by identifying common data elements (CDEs) of COVID-19 and social determinants of health (SDOH) to be collected across the RADx-rad projects; prepare and release data sets in consultation with the DCC Steering Committee in accordance with determined timelines and milestones
- Provide access to tools and resources that support needs of RADx-rad members to make their data FAIR
- Develop model requirements or characteristics of successful tests, including the availability of automatic data capture as well as use of standard LOINC outputs, identity management, device identifiers, etc.
- Provide access to useful and practical administrative data systems that may assist research sites in identifying high-risk populations and subpopulations where increasing testing may be most useful. A centralized data warehouse with integrated data across the RADx-rad projects and related administrative data should be available for secondary data analysis to the RADx-rad awardees and the broader research and practice community.
Budgetary Requirements: Application budgets are limited to $4 Million in annual direct costs.