Portal Of Medical Data Models
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Portal Of Medical Data Models
The portal for medical data models is a German and European medical research infrastructure. It is an open-access metadata-repository initiated for scientific purposes that can generate, analyse, release and reuse medical forms. Background Each day large amounts of data are gathered by electronic health records. Because health care information systems are not compatible among themselves in general, structured data cannot easily be exchanged in between different institutions. Only a small part of all medical forms are openly available. Through this shortness of transparency, data-models adjustment processes in health care are being vastly interfered. Know-how of current or terminated studies and clinical documentation cannot be reused. Goals and target audience Primary goals for medical data models are releasing reliable medical forms and data models, establishing transparent and interoperable standards for medical research and raising efficiency in the design of case report fil ...
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Medical Research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientific principles that may apply to a ''preclinical'' understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term ''clinical trial''. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research i ...
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Open Access
Open access (OA) is a set of principles and a range of practices through which research outputs are distributed online, free of access charges or other barriers. With open access strictly defined (according to the 2001 definition), or libre open access, barriers to copying or reuse are also reduced or removed by applying an open license for copyright. The main focus of the open access movement is "peer reviewed research literature". Historically, this has centered mainly on print-based academic journals. Whereas non-open access journals cover publishing costs through access tolls such as subscriptions, site licenses or pay-per-view charges, open-access journals are characterised by funding models which do not require the reader to pay to read the journal's contents, relying instead on author fees or on public funding, subsidies and sponsorships. Open access can be applied to all forms of published research output, including peer-reviewed and non peer-reviewed academic journa ...
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Metadata Repository
A metadata repository is a database created to store metadata. Metadata is information about the structures that contain the actual data. Metadata is often said to be "data about data", but this is misleading. Data profiles are an example of actual "data about data". Metadata adds one layer of abstraction to this definition– it is data about the structures that contain data. Metadata may describe the structure of any data, of any subject, stored in any format. A well-designed metadata repository typically contains data far beyond simple definitions of the various data structures. Typical repositories store dozens to hundreds of separate pieces of information about each data structure. Comparing the metadata of a couple data items - one digital and one physical - clarify what metadata is: First, digital: For data stored in a database one may have a table called "Patient" with many columns, each containing data which describes a different attribute of each patient. One of these c ...
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Electronic Health Record
An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information. For several decades, electronic health records (EHRs) have been touted as key to increasing of quality care. Electronic health records are used for other reasons than charting for patients; today, providers are using data from patient records to improve quality outcomes through their care management programs. EHR combines all patients demographics into a large pool, and uses this information to assi ...
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Best Practice
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in common ...
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Unified Medical Language System
The Unified Medical Language System (UMLS) is a compendium of many controlled vocabularies in the biomedical sciences (created 1986). It provides a mapping structure among these vocabularies and thus allows one to translate among the various terminology systems; it may also be viewed as a comprehensive thesaurus and ontology of biomedical concepts. UMLS further provides facilities for natural language processing. It is intended to be used mainly by developers of systems in medical informatics. UMLS consists of Knowledge Sources (databases) and a set of software tools. The UMLS was designed and is maintained by the US National Library of Medicine, is updated quarterly and may be used for free. The project was initiated in 1986 by Donald A.B. Lindberg, M.D., then Director of the Library of Medicine, and directed by Betsy Humphreys. Purpose and applications The number of biomedical resources available to researchers is enormous. Often this is a problem due to the large volume o ...
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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 ...
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Redcap (Research Electronic Data Capture)
The redcap (or powrie) is a type of malevolent, murderous goblin found in Border folklore. He is said to inhabit ruined castles along the Anglo-Scottish border, especially those that were the scenes of tyranny or wicked deeds and is known for soaking his cap in the blood of his victims.Henderson, William (1879). ''Folklore of the Northern Counties of England and the Borders'' (2nd ed.) W. Satchell, Peyton & Co. p. 253.Briggs, Katharine (1976). ''An Encyclopedia of Fairies''. Pantheon Books. p. 339. . He is also known as Redcomb and Bloody Cap. Description and behaviour Redcap is depicted as "a short, thickset old elf with long prominent teeth, skinny fingers armed with talons like eagles, large eyes of a fiery red colour, grisly hair streaming down his shoulders, iron boots, a pikestaff in his left hand, and a red cap on his head". When travellers take refuge in his lair, he flings huge stones at them and if he kills them, he soaks his cap in their blood, giving it a crimson hue. ...
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Clinical Document Architecture
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange. In November 2000, HL7 published Release 1.0. The organization published Release 2.0 with its "2005 Normative Edition." Content CDA specifies the syntax and supplies a framework for specifying the full semantics of a clinical document, defined by six characteristics: # Persistence # Stewardship # Potential for authentication # Context # Wholeness # Human readability CDA can hold any kind of clinical information that would be included in a patient's medical record; examples include: * Discharge summary (following inpatient care) * History & physical * Specialist reports, such as those for medical imaging or pathology An XML element in a CDA supports unstructured text, as well as links to composite documents encoded in pdf, docx, or rtf, as well as image formats like jpg and png. It was developed using the ...
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Comma-separated Values
A comma-separated values (CSV) file is a delimited text file that uses a comma to separate values. Each line of the file is a data record. Each record consists of one or more fields, separated by commas. The use of the comma as a field separator is the source of the name for this file format. A CSV file typically stores tabular data (numbers and text) in plain text, in which case each line will have the same number of fields. The CSV file format is not fully standardized. Separating fields with commas is the foundation, but commas in the data or embedded line breaks have to be handled specially. Some implementations disallow such content while others surround the field with quotation marks, which yet again creates the need for escaping if quotation marks are present in the data. The term "CSV" also denotes several closely-related delimiter-separated formats that use other field delimiters such as semicolons. These include tab-separated values and space-separated values. A d ...
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Fast Healthcare Interoperability Resources
The Fast Healthcare Interoperability Resources' (FHIR, pronounced "fire") standard is a set of rules and specifications for exchanging electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide range of settings and with different health care information systems. The goal of FHIR is to enable the seamless and secure exchange of health care information, so that patients can receive the best possible care. The standard describes data formats and elements (known as "resources") and an application programming interface (API) for exchanging electronic health records (EHR). The standard was created by the Health Level Seven International (HL7) health-care standards organization. FHIR builds on previous data format standards from HL7, like HL7 version 2.x and HL7 version 3.x. But it is easier to implement because it uses a modern web-based suite of API technology, including a HTTP-based RESTful protocol, and a choice of JSON, XML or ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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