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Redcap
REDCap (Research Electronic Data Capture) is a browser-based, metadata-driven EDC software and workflow methodology for designing clinical and translational research databases. It is widely used in the academic research community: the REDCap Consortium is a collaborative, international network of more than 5900 institutional partners in 145 countries, with more than 2.1 million total end-users employing the software. Over 19,000 journal articles cite REDCap. History REDCap was developed by an informatics team at Vanderbilt University with ongoing support from NCRR and NIH grants and first released in 2004. REDCap was designed to address common problems for academic biomedical researchers hoping to use electronic databases. First, major vendor EDC and CDMS software is designed and priced for large clinical trials, and can be prohibitively expensive for investigator-initiated studies or other such studies at a smaller scale. Second, the independent research environment often ...
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Vanderbilt University
Vanderbilt University (informally Vandy or VU) is a private university, private research university in Nashville, Tennessee, United States. Founded in 1873, it was named in honor of shipping and railroad magnate Cornelius Vanderbilt, who provided the school its initial $1 million endowment in the hopes that his gift and the greater work of the university would help to heal the sectional wounds inflicted by the American Civil War. Vanderbilt is a founding member of the Southeastern Conference and has been the conference's only private school since 1966. The university comprises ten schools and enrolls nearly 13,800 students from the US and 70 foreign countries. Vanderbilt is Carnegie Classification of Institutions of Higher Education, classified among "R1: Doctoral Universities – Very high research activity". Several research centers and institutes are affiliated with the university, including the Robert Penn Warren, Robert Penn Warren Center for the Humanities, the Freedom Foru ...
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Unix-like
A Unix-like (sometimes referred to as UN*X, *nix or *NIX) operating system is one that behaves in a manner similar to a Unix system, although not necessarily conforming to or being certified to any version of the Single UNIX Specification. A Unix-like Application software, application is one that behaves like the corresponding List of POSIX commands, Unix command or Unix shell, shell. Although there are general Unix philosophy, philosophies for Unix design, there is no technical standard defining the term, and opinions can differ about the degree to which a particular operating system or application is Unix-like. Some well-known examples of Unix-like operating systems include Linux, FreeBSD and OpenBSD. These systems are often used on servers as well as on personal computers and other devices. Many popular applications, such as the Apache HTTP Server, Apache web server and the Bash (Unix shell), Bash shell, are also designed to be used on Unix-like systems. Definition The Open ...
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Windows
Windows is a Product lining, product line of Proprietary software, proprietary graphical user interface, graphical operating systems developed and marketed by Microsoft. It is grouped into families and subfamilies that cater to particular sectors of the computing industry – Windows (unqualified) for a consumer or corporate workstation, Windows Server for a Server (computing), server and Windows IoT for an embedded system. Windows is sold as either a consumer retail product or licensed to Original equipment manufacturer, third-party hardware manufacturers who sell products Software bundles, bundled with Windows. The first version of Windows, Windows 1.0, was released on November 20, 1985, as a graphical operating system shell for MS-DOS in response to the growing interest in graphical user interfaces (GUIs). The name "Windows" is a reference to the windowing system in GUIs. The 1990 release of Windows 3.0 catapulted its market success and led to various other product families ...
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Linux
Linux ( ) is a family of open source Unix-like operating systems based on the Linux kernel, an kernel (operating system), operating system kernel first released on September 17, 1991, by Linus Torvalds. Linux is typically package manager, packaged as a Linux distribution (distro), which includes the kernel and supporting system software and library (computing), libraries—most of which are provided by third parties—to create a complete operating system, designed as a clone of Unix and released under the copyleft GPL license. List of Linux distributions, Thousands of Linux distributions exist, many based directly or indirectly on other distributions; popular Linux distributions include Debian, Fedora Linux, Linux Mint, Arch Linux, and Ubuntu, while commercial distributions include Red Hat Enterprise Linux, SUSE Linux Enterprise, and ChromeOS. Linux distributions are frequently used in server platforms. Many Linux distributions use the word "Linux" in their name, but the Free ...
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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 ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ...
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Case Report Form
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.) The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and ...
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Metadata
Metadata (or metainformation) is "data that provides information about other data", but not the content of the data itself, such as the text of a message or the image itself. There are many distinct types of metadata, including: * Descriptive metadata – the descriptive information about a resource. It is used for discovery and identification. It includes elements such as title, abstract, author, and keywords. * Structural metadata – metadata about containers of data and indicates how compound objects are put together, for example, how pages are ordered to form chapters. It describes the types, versions, relationships, and other characteristics of digital materials. * Administrative metadata – the information to help manage a resource, like resource type, and permissions, and when and how it was created. * Reference metadata – the information about the contents and quality of Statistical data type, statistical data. * Statistical metadata – also called process data, may ...
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Electronic Data Capture
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO). Typically, EDC systems provide: * a graphical user interface component for data entry * a validation component to check user data * a de-identification component to make data less identifiable * a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC c ...
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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 ...
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Translational Research
Translational research (also called translation research, translational science, or, when the context is clear, simply translation) is research aimed at translating (converting) results in basic research into results that directly benefit humans. The term is used in science and technology, especially in biology and medical science. As such, translational research forms a subset of applied research. The term has been used most commonly in life sciences and biotechnology, but applies across the spectrum of science and humanities. In the context of biomedicine, translational research is also known as bench to bedside. In the field of education, it is defined as research which translates concepts to classroom practice. Critics of translational medical research (to the exclusion of more basic research) point to examples of important drugs that arose from fortuitous discoveries in the course of basic research such as penicillin and benzodiazepines. Other problems have stemmed from ...
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National Center For Research Resources
The National Center for Research Resources (NCRR) was a center within the National Institutes of Health, a United States government agency. NCRR provided funding to laboratory scientists and researchers for facilities and tools in the goal of curing and treating diseases. Organization and history The National Center for Research Resources (NCRR) was one of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the Department of Health and Human Services of the federal government of the United States The Federal Government of the United States of America (U.S. federal government or U.S. government) is the Federation#Federal governments, national government of the United States. The U.S. federal government is composed of three distinct .... The NIH is one of eight agencies under the Public Health Service (PHS) in the Department of Health and Human Services (HHS). In 1990 the Division of Research Resources and the Division of Research ...
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