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Clinical Trial Management System
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones. Terminology ''eClinical'' is a term used within the biopharmaceutical industry to refer to trial automation technology. Originally, "eClinical" was used to refer to any involved technology. Without a more specific definition, the industry used "eClinical" to name technologies such as electronic data capture, clinical trial management systems or Randomization and Trial Supply Management systems, commonly using Interactive voice response systems, electronic patient diaries and other applications. More recently, the term evolved to encompass the entire "business process" instead of individual technologies. An example of an "eClinical solution" is the combination of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software
Software consists of computer programs that instruct the Execution (computing), execution of a computer. Software also includes design documents and specifications. The history of software is closely tied to the development of digital computers in the mid-20th century. Early programs were written in the machine language specific to the hardware. The introduction of high-level programming languages in 1958 allowed for more human-readable instructions, making software development easier and more portable across different computer architectures. Software in a programming language is run through a compiler or Interpreter (computing), interpreter to execution (computing), execute on the architecture's hardware. Over time, software has become complex, owing to developments in Computer network, networking, operating systems, and databases. Software can generally be categorized into two main types: # operating systems, which manage hardware resources and provide services for applicat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Government
A government is the system or group of people governing an organized community, generally a State (polity), state. In the case of its broad associative definition, government normally consists of legislature, executive (government), executive, and judiciary. Government is a means by which organizational policies are enforced, as well as a mechanism for determining policy. In many countries, the government has a kind of constitution, a statement of its governing principles and philosophy. While all types of organizations have governance, the term ''government'' is often used more specifically to refer to the approximately 200 list of sovereign states, independent national governments and government agency, subsidiary organizations. The main types of modern political systems recognized are democracy, democracies, totalitarian regimes, and, sitting between these two, authoritarianism, authoritarian regimes with a variety of hybrid regimes. Modern classification systems also ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Database Administrators
In computing, a database is an organized collection of Data (computing), data or a type of data store based on the use of a database management system (DBMS), the software that interacts with end users, Application software, applications, and the database itself to capture and analyze the data. The DBMS additionally encompasses the core facilities provided to administer the database. The sum total of the database, the DBMS and the associated applications can be referred to as a database system. Often the term "database" is also used loosely to refer to any of the DBMS, the database system or an application associated with the database. Before digital storage and retrieval of data have become widespread, index cards were used for data storage in a wide range of applications and environments: in the home to record and store recipes, shopping lists, contact information and other organizational data; in business to record presentation notes, project research and notes, and contact ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biostatistician
Biostatistics (also known as biometry) is a branch of statistics that applies statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experiments and the interpretation of the results. History Biostatistics and genetics Biostatistical modeling forms an important part of numerous modern biological theories. Genetics studies, since its beginning, used statistical concepts to understand observed experimental results. Some genetics scientists even contributed with statistical advances with the development of methods and tools. Gregor Mendel started the genetics studies investigating genetics segregation patterns in families of peas and used statistics to explain the collected data. In the early 1900s, after the rediscovery of Mendel's Mendelian inheritance work, there were gaps in understanding between genetics and evolutionary Darwinism. Francis Galton tried to expand Mendel's ... [...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] |
NCI-designated Cancer Center
NCI-designated Cancer Centers are a group of 73 cancer research institutions in the United States supported by the National Cancer Institute. Three designations are recognized: ''Comprehensive Cancer Centers'', ''Clinical Cancer Centers'' and ''Basic Laboratory Cancer Centers''. , there are 9 Clinical Cancer Centers, 57 Comprehensive Cancer Centers and 7 Basic Laboratory Cancer Centers. Most are associated with a university. Receiving the NCI-designation places cancer centers among the top 4% of the approximately 1,500 cancer centers in the United States. In 2021, more than 411,000 new patients were enrolled in a clinical trial at an NCI-designated Cancer Center. Program Designation process The NIH funds cancer centers through a P30 Cancer Center Support Grant (CCSG) mechanism. To be eligible to apply, a cancer center must receive at least $10 million in cancer research funding annually. Preparation for these grant applications can be extensive. The most recent grant applicati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Academic Medical Center
The Academic Medical Center (Dutch: ''Academisch Medisch Centrum''), or AMC, was the university hospital affiliated with the University of Amsterdam. After merging with the VU University Medical Center, it now operates as the Amsterdam University Medical Center, a single organization with two locations, affiliated with two universities. It was one of the largest and leading hospitals of the Netherlands, located in the Bijlmer neighborhood in the most south-eastern part of the city of Amsterdam. AMC consistently ranked among the top 50 medical schools in the world. History The Academic Medical Center was founded in the year 1983, it stands as one of the Netherlands' most extensive and technologically advanced hospitals, boasting a global medical ranking of approximately the fiftieth position. Services The AMC has had an intensive cooperation with the other university hospital of Amsterdam, the VU University Medical Center (VUmc), affiliated with the Vrije Universiteit Amsterd ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monitoring In Clinical Trials
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Document Management System
A document management system (DMS) is usually a computerized system used to store, share, track and manage files or documents. Some systems include history tracking where a log of the various versions created and modified by different users is recorded. The term has some overlap with the concepts of content management systems. It is often viewed as a component of enterprise content management (ECM) systems and related to digital asset management, document imaging, workflow systems and records management systems. History While many electronic document management systems store documents in their native file format (Microsoft Word or Excel, PDF), some web-based document management systems are beginning to store content in the form of HTML. These HTML-based document management systems can act as publishing systems or policy management systems. Content is captured either by using browser based editors or the importing and conversion of not HTML content. Storing documents as HTML ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Compliance
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Compliance has traditionally been explained by reference to deterrence theory, according to which punishing a behavior will decrease the violations both by the wrongdoer (specific deterrence) and by others (general deterrence). This view has been supported by economic theory, which has framed punishment in terms of costs and has explained compliance in terms of a cost-benefit equilibrium (Becker 1968). However, psychological research on motivation provides an alternative view: granting rewards (Deci, Koestner and Ryan, 1999) or imposing fines (Gneezy Rustichini 2000) for a certain behavior is a form of extrinsic motivation that weakens intrinsic motivation and ultimately undermines compliance. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Event
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs, or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
