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Below is from the CD2H Coordinating center Funding Opportunity Announcement (FOA) and should guide the activities.

Applicants for the CD2H-CC should design projects that:

FOA.1: Support and enhance a collaborative informatics community

FOA.2: Develop Good Data Practice (GDP)

FOA.3: Promote software development standards for interoperability

FOA.4: Foster collaborative informatics innovation

FOA.5: Data science education

FOA.6: Evaluate impact

FOA.1: Support and enhance a collaborative informatics community for the CTSA Program:

  • Facilitating the communication with key stakeholders, including the CTSA Program informatics domain task force and External Scientific Consultants, to identify high impact informatics projects that advance and encompass the full spectrum of translational research, including preclinical research, clinical research and/or the engagement of communities in research.
  • Providing a governance structure for the CTSA Program community that develops a transparent, reproducible, and inclusive process for the evaluation of such high impact informatics projects.
  • Providing an inclusive framework to collaboratively develop well-defined multi-site projects that should include time-limited milestones, expected outcomes and evaluation measures.
  • Create a process for the assessment of merit-based projects that may include the consideration of the project’s impact within the CTSA Program, overall goals of enhancing efficiency and performance, and/or reducing costs.
  • Establishing processes and methods for common IT architecture for the CTSA Program Consortium including defining technical standards, identifying security requirements, and identifying and integrating existing resources.
  • Fostering and promoting the development of an academic attribution and reimbursement framework for informatics products and processes. These processes could allow the contribution to be used for academic promotion.
  • Providing a secure internet-based infrastructure (web-portal or other method) to support communications, document and resource sharing. Innovative synchronous and asynchronous communication and messaging are encouraged for the various activities.

FOA.2: Develop Good Data Practice (GDP) of clinical and research data to maximize the potential for health impact of various types of data and to facilitate rigorously conducted research:

Promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles:

  • Findable: Data should be uniquely and persistently identifiable and should minimally contain basic machine actionable metadata.
  • Accessible: Data should be accessible so it can be always obtained by machines and humans, after appropriate authorization, through a well-defined telecommunications protocol (TCP) or internet provider (IP).
  • Interoperable: Promoting interoperable data with the use or creation of metadata annotation/algorithms, a formal accessible language for knowledge representation, and using standard vocabularies [Systemized Nomenclature of Medicine-Clinical Terms (SnoMed-CT), International - Classification of Diseases Ninth and Tenth Revision (ICD-9 / ICD-10), Human Phenotype Ontology (HPO), Monarch, Unified Medical Language System (UMLS), Logical Observation Identifiers Names and Codes (LOINC), etc.)
  • Re-useable: Promoting data re-usability with relevant attributes, data usage license, and provenance (integrity and validity).

FOA.3: Promote software development standards for interoperability:

  • Creating and/or enhancing the use of software development standards. There is high need for the development and use of software development standards in order to facilitate the creation of collaborative informatics tools, methods, processes, and technologies that will be widely used to advance translational science.
  • Facilitating the collaborative engagement of other stakeholders [e.g. federal partners and standards bodies such as the National Library of Medicine (NLM), Food and Drug Administration (FDA), Health - Level Seven International (HL7), Office of the National Coordinator for Health Information Technology (ONC), Clinical Data Interchange Standards Consortium (CDISC), etc.].
  • Supporting best practices to ensure the licensing of products, methods, and processes developed with the support of federal funds are freely available (open source) for the CTSA Program community and other stakeholders. This may include the following considerations as consistent with standard software development life cycle requirements:
  • Quality control: assurances that all products developed under this cooperative agreement meet the highest standards of quality including usability, functionality, dependability, interoperability, security, deployment and maintenance.
  • Accessibility: products that are developed under this cooperative agreement should become a national resource that could be used within the collaborative informatics laboratory environment and be accessible to all investigators.
  • Provenance: Ensure derivatives of the products are owned by the authors of said products.
  • Maintenance: Plans for maintenance of the products produced.
  • Support: Ensure that customer support is available and responsive.
  • Interoperability: Ensure that all products developed under this cooperative agreement could be interoperable and that the source code will be accessible.
  • Evaluation measures: Metrics for performance of the product should be made available.

FOA.4: Foster collaborative innovation in the area of informatics tools, methods and processes by:

  • Creating a collaborative informatics laboratory to be used as a CTSA Program consortium-wide resource, where novel ideas and products could be created, tested, prototyped, disseminated and maintained as well as collaboratively used.
  • Fostering the identification of commercial tools by stakeholders that are thought to provide high value for the Consortium to facilitate translational science projects. The CD2H-CC may be a central negotiator with vendors of commercial tools.
  • Developing a sustainable model for the informatics products produced and used. This may include developing a public private partnership model that would allow the possibility for investigators to develop and commercialize their tools and encouraging entrepreneurship that may include a mechanism where derivative versions of a product can be used for commercialization.

FOA.5: Stimulate the use of cutting edge biomedical research informatics by providing data science education for CTSA Program researchers.

  • Disseminate educational informatics resources and other products and provide a forum that will provide an assessment of the value of these products. Disseminate high-quality educational resources and materials (e.g. Massive Open Online Courses or MOOCs), including workshops, externship offerings, conferences and courses.

FOA.6: Evaluate the impact of CD2H-CC activities to enhance health care through the use of informatics resources. This may include:

  • Developing and implementing a model for continuous quality improvement (CQI) where projects are continuously measured and modified.
  • Developing a system where quantifiable, measurable, and actionable results of the impact of the products of the CD2H-CC are reported.
  • Supporting the publication of the impact of the tools, methods, and processes deployed.