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NCI EVS has extensive partnerships with government and standards= organizations beyond NIH to develop terminology standards, content, techno= logy, and operational support. Such partnerships are designed to dire= ctly support NCI's cancer research mission, improving regulatory, federal a= nd community practices in ways that contribute to the conduct and sharing o= f cancer research while also having a positive impact on the wider biomedic= al community. The following collaborations are included in this section:
FDA has worked with EVS since 2001, with formal Memoranda of Understandi= ng starting in 2004, to develop and harmonize terminology content, standard= s and systems in areas of mutual interest such as drugs, devices, patient s= afety, and clinical trials. FDA has chosen EVS and NCI Thesaurus (NCIt) for= developing and publishing many important terminology sets; some 15,000 FDA= terms in over 20 defined subsets are now maintained in NCIt and required f= or regulatory reporting and other purposes. These include:
EVS resources and systems are also used in FDA efforts such as the Janus Clinical = Trials Repository (CTR) Project , a standards-based repository= of subject level clinical trial data to support regulatory review and pati= ent centered outcomes research (PCOR).
For more information, visit the NCI website FDA terminology resources.
EVS Related References
CDISC is an international, non-profit organization that develops and sup= ports global data standards for medical research. CDISC is working actively= with EVS to develop and support controlled terminology for a wide spectrum= of clinical and nonclinical studies.
CDISC terminology is being widely adopted as a standard for study coding= and data submissions. In the United States, draft FDA guidance on regulato= ry submissions (see Study Data Technical Conformance Guide) recommends CDISC ter= minology as a set of controlled terms that meet the FDA requirements for th= e implementation of the CDISC standards. As part of the General Considerati= ons of Controlled Terminology regarding CDISC, the Guide states: "Sponsors = should use the terminologies and code lists in the CDISC Controlled Termino= logy, which can be found at the NCI (National Cancer Institute) Enterprise = Vocabulary Services."
CDISC terminology goes through an extensive process of content developme= nt and public review before it is declared ready for release. All CDISC con= trolled terminology =E2=80=93 more than 10,000 terms =E2=80=93 is maintaine= d and published as NCI Thesaurus (NCIt) subsets, as part of a partnership s= tarted in 2002. The main terminology efforts encompassed by the CDISC-EVS p= artnership are shown below:
The CDISC Shared Health and Research Electronic Library (SHARE)<= /strong> project aims to create a global, electronically accessible library= of CDISC standard metadata that can be used to improve biomedical research= and its link with healthcare. The SHARE metadata repository (MDR) provides= a dynamic environment where the relationships between and among CDISC meta= data and controlled terminologies are published at a level of granularity t= hat is user-defined and in forms that are both human and machine readable. = The SHARE MDR is built using CDISC and BRIDG metadata and terminology that = is coded and maintained in the EVS NCIt environment. More information is av= ailable at CDISC=E2=80=99s SHARE Web page = .
For more information, visit the NCI website CDISC terminology resources.
EVS Related References
CFAST is a joint initiative of the Clinical Data Interchange Standards C= onsortium (CDISC) and the Critical Path Institute (C-Path), with steering c= ommittee participation from the US Food and Drug Administration (FDA), the = National Cancer Institute Enterprise Vocabulary Services (NCI EVS) and Tran= sCelerate BioPharma (TCB). Its purpose is to create therapeutic area-specif= ic data standards to support clinical research in areas of particular impor= tance to public health. Section XII of the Prescription Drug User Fee Act V= (PDUFA V) provides the directive for FDA support for this Data Standards f= or Therapeutic Areas initiative. More information is available on the CFAST Web pages of CDISC and C-Path , and on the= FDA Therapeutic Areas Web page.
Therapeutic area teams follow a CFAST-approved process that incorporates= stakeholder inputs and public review to produce therapeutic area user guid= es, questionnaire supplements and controlled terminology. Controlled termin= ology goes through an extensive process of content development and public r= eview before it is declared ready for release. All controlled terminology d= eveloped by the therapeutic area teams is published as part of the CDISC co= ntrolled terminology standards.
For more information on CDISC controlled terminology, visit the NCI webs= ite CDISC Terminology= resources.
EVS Related References
NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organi= zation with over 1,600 members representing virtually every sector of the p= harmacy services industry. NCPDP creates and promotes the transfer of data = related to medications, supplies, and services within the healthcare system= through the development of standards and industry guidance. In 2009, NCPDP= decided to partner with EVS to use NCIt subsets to support two of those st= andards, employed by some 200 vendors serving approximately 15,000 pharmaci= es nationwide:
For more information, visit the NCI website NCPDP Terminology resources.
EVS Related References
Work started in 2002 as an interagency collaboration between NCI EVS, FD= A, VHA, and NLM =E2=80=93 joined later by AHRQ, CMS, DoD, and EPA =E2=80=93= to improve the exchange and public availability of medication information = with coordinated development of terminology standards. The initial FMT term= inology set has been endorsed by U.S. Federal standards efforts including t= he National Committee on Vital and Health Statistics (NCVHS), Consolidated = Health Informatics (CHI), the Healthcare Information Technology Standards P= anel (HITSP), and the Office of the National Coordinator for Health Informa= tion Technology (ONC) within the Department of Health and Human Services (H= HS).
For more information, visit the NCI Website Federal Medication Terminologies resources.
EPA joined in the Federal Medication Terminologies (FMT) collaboration= . EPA has also developed an EPA Science Vocabulary that utilizes= substantial content from NCI Thesaurus, particularly for definitions, in a= ddition to content from numerous EPA glossaries and other documents, and fr= om other terminologies such as the Human Disease Ontology. It will be= made publicly available in December 2014.
VHA has worked closely with EVS since 2002. Under an ongoing Memorandum = of Understanding, VHA works with EVS on collaborative terminology policy an= d products, including content collaboration and publication of the VA's Nat= ional Drug File Reference Terminology (NDF-RT), used by both agencies as a = drug information reference resource.
The VHA also performed a thorough comparison of the functional capabilit= ies of LexEVS to those of other terminology servers. The VA provided the re= sults to the VKC, which transformed the matrix into a document that can be = used by potential adopters of LexEVS as they evaluate the capabilities of t= he system. This is an example of a valuable contribution from the community= that is not code-based; in an open source model, contributions of document= ation can be as important as contributions of code.
MedDRA is an international terminology for coding and regulatory reporti= ng of drug and device adverse events. MedDRA is an International Conference= on Harmonisation of Technical Requirements for Registration of Pharmaceuti= cals for Human Use (ICH) standard, adopted by FDA and many other agencies. = MedDRA is used by more than 3,000 regulatory, industry and academic subscri= bers from 60 countries, and has been translated into 11 languages.
EVS manages the MedDRA license for NIH, and publishes multiple versions = through LexEVS, the NCI Term Browser, and other means. EVS maintains multip= le versions of MedDRA on its servers and browsers to support validation and= interpretation of data encoded with those versions.
Over 10 years, EVS has performed numerous mapping comparisons between Me= dDRA and NCI terminologies including NCI Thesaurus (NCIt), PDQ, CTEP SDC, a= nd CTCAE, as part of ongoing efforts to promote compatibility and data tran= slation between these sources. NCI Metathesaurus maintains mappings between= MedDRA and more than 70 other biomedical terminologies, providing a rich s= ource of additional description of MedDRA terms and supporting data transla= tion and analysis.
EVS and the MedDRA Maintenance and Support Services Organization (M= SSO) are working with the UK Medicines and Healthcare products Re= gulatory Agency (MHRA) on use of the EVS Mapping Tool to develop an i= nitial proof-of-concept mapping from SNOMED CT to MedDRA, focusing on high = frequency adverse event terms to test the possibility of automated conversi= on of EHR data to support more proactive identification of potential signal= s with drugs that have gained marketing approval.
EVS and the MSSO have worked with NICHD, FDA, and other partners in deve= loping a specialized set of pediatric adverse event terminology for use in = research and care, as a part of the larger Pediatric Terminology Subset in = NCIt and also for inclusion and distribution as part of MedDRA. For more in= formation, visit the NCI website pediatric terminology page.
EVS has made numerous contributions to updates of MedDRA terminology. EV= S conducted a comprehensive review of the over 8,500 terms in MedDRA's Neop= lasm classification, suggesting changes initially presented to a special Bl= ue Ribbon Panel meeting in 2011. NCIt is used as the primary reference term= inology for updates to MedDRA neoplastic terminology. The MedDRA Brow= ser now includes more than 10,000 link-outs to full-text term definitions i= n NCIt.
The International Classification of Diseases (ICD) is the global standar= d diagnostic classification for all general epidemiological and many health= management purposes, and has many clinical uses. WHO work on the Internati= onal Classification of Diseases 11th revision (ICD-11) is using NCI Thesaur= us (NCIt) as an important source of cancer-related terminology, relationshi= ps, and other features such as definitions. EVS has helped facilitate acces= s to and reuse of NCIt content, as well as expert review and suggestions on= some draft ICD-11 content; the oncology-specific ICD-O is also being influ= enced by NCIt's in-depth characterization of cancers and other neoplasms.= p>
WHO is also taking advantage of EVS-supported open source terminology to= oling in its work. In June 2009, WHO requested a Classification Markup Lang= uage (ClaML) LexEVS data processing program that could be used to render IC= D-10 in preparation for, and as the foundation of, ICD-11. Stanford Univers= ity's Prot=C3=A9g=C3=A9 and related terminology editing tools are also a vi= tal component of WHO efforts.
EVS supports terminology content for the Regulated Clinical Research Inf= ormation Management (RCRIM) committee of HL7, and for other committees as a= ppropriate including Patient Safety, Pharmacy, Clinical Genomics, and the C= linical Interoperability Council.
CareLex=E2=84=A2 (http://www.carelex.org/) is a publicly fund= ed not-for-profit enterprise working to improve information interoperabilit= y in health sciences to accelerate delivery of new therapies to patients.&n= bsp; To achieve this, CareLex actively partners with the biopharmaceutical = industry, researchers, contract research organizations (CROs), technology e= xperts, allied professionals, and government regulators to develop and mana= ge open source technologies and advance global standards for clinical trial= s data interoperability.
EVS has worked with CareLex since 2013 to help develop and publish termi= nology for their electronic Trial Master File (eTMF) Standards Initiative.&= nbsp; This terminology is maintained and distributed as part of NCI Thesaur= us (NCIt), and can be found at http://evs.nci.nih.= gov/ftp1/CareLex/About.html .
The Taiwan Cancer Registry, a population-based cancer registry founded i= n 1979, uses NCI Thesaurus terminology. Hospitals with greater than 50-bed = capacity that provide outpatient and hospitalized cancer care are recruited= to participate in reporting all newly diagnosed malignant neoplasms to thi= s registry.
EVS Related References
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