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CDISC Migration
The Clinical Data Interchange Standards Consortium (CDISC) is a Standard-developing organization, standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and 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. Since December 2016, CDISC standards are mandatory for submission to US FDA. CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an International Organization for Standardization, ISO/European Committee for Standardization, CEN standard. History * Late 1997 – Started as a Volunteer group * Summer 1998 – Invited to form DIA SIAC * 1999 – SDS v1.0; ODM v0.8 * ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Management System
Clinical may refer to: Healthcare * Of or about a clinic, a healthcare facility * Of or about the practice of medicine Other uses * ''Clinical'' (film), a 2017 American horror thriller See also * * * Clinical chemistry, the analysis of bodily fluids for diagnostic and therapeutic purposes * Clinical death, the cessation of blood circulation and breathing * Clinical formulation, a theoretically-based explanation of information obtained from clinical assessment * Clinical governance, a systematic approach to maintaining and improving the quality of patient care * Clinical linguistics, linguistics applied to speech-language pathology * Clinical psychology, the understanding, preventing, and relieving psychologically-based distress or dysfunction * Clinical research, to determine the safety and effectiveness of medications etc. * Clinical significance, the practical importance of a treatment effect * Clinical trial, experiments or observations done in clinical research * Clinical w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standards Organizations In The United States
Standard may refer to: Symbols * Colours, standards and guidons, kinds of military signs * Standard (emblem), a type of a large symbol or emblem used for identification Norms, conventions or requirements * Standard (metrology), an object that bears a defined relationship to a unit of measure used for calibration of measuring devices * Standard (timber unit), an obsolete measure of timber used in trade * Breed standard (also called bench standard), in animal fancy and animal husbandry * BioCompute Standard, a standard for next generation sequencing * ''De facto'' standard, product or system with market dominance * Gold standard, a monetary system based on gold; also used metaphorically for the best of several options, against which the others are measured * Internet Standard, a specification ratified as an open standard by the Internet Engineering Task Force * Learning standards, standards applied to education content * Standard displacement, a naval term describing th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Management
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics. Role of the clinical data manager in a clinical trial Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial form the basis of subsequent safety ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms. Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment. Description The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants. Clinical research can cover any medical method or product from it ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 Intern ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Systematized Nomenclature Of Medicine
The Systematized Nomenclature of Medicine (SNOMED) is a systematic, computer-processable collection of medical terms, in human and veterinary medicine, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, procedures, microorganisms, substances, etc. It allows a consistent way to index, store, retrieve, and aggregate medical data across specialties and sites of care. Although now international, SNOMED was started in the U.S. by the College of American Pathologists (CAP) in 1973 and revised into the 1990s. In 2002 CAP's SNOMED Reference Terminology (SNOMED RT) was merged with, and expanded by, the National Health Service's Clinical Terms Version 3 (previously known as the Read codes) to produce SNOMED CT. Versions of SNOMED released prior to 2001 were based on a multiaxial, hierarchical classification system. As in any such system, a disease may be located in a body organ (anatomy), which results in a code in a topography axis and may lead to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 clinical care and management database 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 main part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Level 7
Health Level Seven, abbreviated to HL7, is a range of global standards for the transfer of clinical and administrative health data between applications with the aim to improve patient outcomes and health system performance. The HL7 standards focus on the application layer, which is "layer 7" in the Open Systems Interconnection model. The 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. There are a range of primary standards that are commonly used across the industry, as well as secondary standards which are less frequently adopted. Purpose Health organizations typically have many different computer systems used to process different patient administration or clinical tasks, such as billing, medication management, patient tracking, and documentation. All of these systems should comm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
ECTD
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). History Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. , the most current version is 3.2.2, released on July 16, 2008. A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that mi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Digital Imaging And Communications In Medicine
Digital Imaging and Communications in Medicine (DICOM) is a technical standard for the digital storage and transmission of medical images and related information. It includes a file format definition, which specifies the structure of a DICOM file, as well as a network communication protocol that uses TCP/IP to communicate between systems. The primary purpose of the standard is to facilitate communication between the software and hardware entities involved in medical imaging, especially those that are created by different manufacturers. Entities that utilize DICOM files include components of picture archiving and communication systems (PACS), such as imaging machines (modalities), radiological information systems (RIS), scanners, printers, computing servers, and networking hardware. The DICOM standard has been widely adopted by hospitals and the medical software industry, and is sometimes used in smaller-scale applications, such as dentists' and doctors' offices. The Nation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
