In May, 2012, the NCI implemented The National Cancer Informatics Program to support the biomedical informatics needs of the cancer research community and to support research at a variety of levels, ranging from analysis of experiments performed by individual investigators to creating the enterprise infrastructure for large distributed cooperative trials, translational research, and large scale genomics research. The NCIP is chartered to develop a new vision for interoperable biomedical information systems, built on community-driven data standards to support the cancer research enterprise. At a high-level, the NCIP covers three component parts. These include: Clinical and Translational Research, Cancer Biology and Genomics Research, and Semantics and Interoperability. Clinical and Translational Research Informatics Emphasis is on providing the NCI with informatics support where clinical, medical, clinical trial expertise is essential to the understanding or success of the project. In addition to providing support for clinical trials reporting, clinical trials data management, and general informatics support, we also maintain a relationship with regulatory and medical standards bodies such as the FDA, HL7 and CDISC for the purpose of assisting the NCI in regulatory compliance and assuring that clients are able to leverage medical informatics standards as appropriate. Projects supported include; clinical trial portfolio management (Clinical Trials Reporting Program, Clinical Trials Reporting Office), clinical trials data management (Rave, C3D), clinical imaging (Cancer Imaging Program, The Cancer Imaging Archive), regulatory activities (participation in HL7, CDISC), and support for precision medicine (MATCH). Cancer Biology and Genomics Research Informatics Particular emphasis is placed on support for genomic data management and sharing, but will be broadening to support proteomics and integration with clinical data. Bioinformatics and computational genomics analysis, training, and support for scientific software are provided for intramural research projects. Coordination is provided for the Informatics Technology for Cancer Research (ITCR) extramural program. There is significant involvement with the NIH Big Data to Knowledge (BD2K) Program and other activities of the Office of the Associate Director for Data Science (ADDS), with several staff leading or participating in guiding the scientific goals of those programs. Other activities include support for the following NCI programs: TARGET, TCGA, CGAP and other data collections, and the Nano-informatics Working Group. Semantics and Interoperability The scope of this activity is to define, implement, and support community use of vocabulary and standards infrastructure and content, which enable data and system interoperability to support the cancer research endeavor, including: Enterprise Vocabulary Services oNCI Thesaurus (NCIt) and NCI Metathesaurus (NCIm) oHosting other terminologies used by cancer community, e.g., CTCAE, MedDRA oSupporting extension & mapping of terminologies, e.g., CTRP, CTCAE, etc. Metadata Standards development, harmonization, and curation oSupporting Common Data Elements (CDEs), Case Report Forms (CRF), and questionnaires to support Clinical Trials, CTEP, CTCAE, etc. oProviding support and training for caDSR curators and users oDefining & Implementing Next-Generation Metadata Resources Participating in HHS-wide and broader standards activities oActive participation in standards efforts of strategic importance to NIH and NCI (e.g., FDA, CDISC, CFAST, NCPDP, WHO, MedDRA, HL7, ONC, ISO, IHE) oEngagement in NIH BMIC & BD2K initiatives

National Institute of Health (NIH)
National Cancer Institute (NCI)
Scientific Computing Intramural Research (ZIH)
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