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CDISC
The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process. CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/ CEN standard. History * Late 1997 – Started as a Volunteer group * Summer 1998 – Invited to form DIA SIAC * 1999 – SDS v1.0; ODM v0.8 * 2000 – SDS v1.1 * Feb 2000 – Formed an Independent, non-profit organization * Dec 2001 – Global participation * 2001 – SDS v2.0; ODM v1.0 * 2002 – ODM v1.1; ADaM v1.0 * 2003 – LAB v1.0; SDTM ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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SDTM
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. Eventually, all data submissions will be expected to conform to this format. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management. Background SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Standard For Exchange Of Non-clinical Data
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development. Raw data of toxicology animal studies started after December 18, 2016 to support submission of new drugs to the US Food and Drug Administration will be submitted to the agency using SEND. Having a common model to which the industry can conform enables benefits such as the ability for vendors to develop tools, for inter-organizational data exchange that is consistent in format regardless of the parties involved, and so on. A SEND package consists of a few parts, but the main focus is on individual endpoint data. Endpoints typically map to domains (essentially, datasets), with a number of variables (a.k.a., columns or fields). Implementation The SEND Implementation Guide (SE ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Data Definition Specification
In computing, a data definition specification (DDS) is a guideline to ensure comprehensive and consistent data definition. It represents the attributes required to quantify data definition. A comprehensive data definition specification encompasses enterprise data, the hierarchy of data management, prescribed guidance enforcement and criteria to determine compliance. Overview A data definition specification may be developed for any organization or specialized field, improving the quality of its products through consistency and transparency. It eliminates redundancy (since all contributing areas are referencing the same specification) and provides standardization, making it easier and more efficient to create, modify, verify, analyze and share information across the enterprise. To understand how a data definition specification works in an enterprise, we must look at the elements of a DDS. Writing data definitions, defining business terms (or rules) in the context of a particular ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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SNOMED CT
SNOMED CT or SNOMED Clinical Terms is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. SNOMED CT is considered to be the most comprehensive, multilingual clinical healthcare terminology in the world. The primary purpose of SNOMED CT is to encode the meanings that are used in health information and to support the effective clinical recording of data with the aim of improving patient care. SNOMED CT provides the core general terminology for electronic health records. SNOMED CT comprehensive coverage includes: clinical findings, symptoms, diagnoses, procedures, body structures, organisms and other etiologies, substances, pharmaceuticals, devices and specimens. SNOMED CT is maintained and distributed by SNOMED International, an international non-profit standards development organization, located in London, UK. SNOMED International is the trading name of the Inter ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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LOINC
Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit medical research organization. LOINC was created in response to the demand for an electronic database for clinical care and management and is publicly available at no cost. It is endorsed by the American Clinical Laboratory Association. Since its inception, the database has expanded to include not just medical laboratory code names but also nursing diagnosis, nursing interventions, outcomes classification, and patient care data sets. Function ''LOINC'' applies universal code names and identifiers to medical terminology related to electronic health records. The purpose is to assist in the electronic exchange and gathering of clinical results (such as laboratory tests, clinical observations, outcomes management and research). LOINC has two ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Health Level 7
Health Level Seven or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. These standards focus on the application layer, which is "layer 7" in the OSI model. The HL7 standards are produced by Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardization. Hospitals and other healthcare provider organizations typically have many different computer systems used for everything from billing records to patient tracking. All of these systems should communicate with each other (or "interface") when they receive new information, or when they wish to retrieve information, but not all do so. HL7 International specifies a number of flexible standards, guidelines, and methodologies by which various healthcare systems can c ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Health Informatics Service Architecture
The European Committee for Standardization ( CEN) Standard Architecture for Healthcare Information Systems (ENV 12967), Health Informatics Service Architecture or HISA is a standard that provides guidance on the development of modular open information technology (IT) systems in the healthcare sector. Broadly, architecture standards outline frameworks which can be used in the development of consistent, coherent applications, databases and workstations. This is done through the definition of hardware and software construction requirements and outlining of protocols for communications. The HISA standard provides a formal standard for a service-oriented architecture (SOA), specific for the requirements of health services, based on the principles of Open Distributed Processing. The HISA standard evolved from previous work on healthcare information systems architecture commenced by Reseau d’Information et de Communication Hospitalier Europeen (RICHE) in 1989, and subsequently built upon ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |