Standard Operating Procedure
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Standard Operating Procedure
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. Some military services (e.g., in the U.S. and the UK) use the term standing (rather than ''standard'') operating procedure, since a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" could suggest that only one (standard) procedure is to be used across all units. The term is sometimes used facetiously to refer to practices that are unconstructive, yet the norm. In the Philippines, for instance, "SOP" is the term for pervasive corruption within the government and its institutions. Clinical research and practice In clinical research, the '' International Council for Harmonisation'' (ICH) defines SOPs as "de ...
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Organization
An organization or organisation (Commonwealth English; see spelling differences), is an entity—such as a company, an institution, or an association—comprising one or more people and having a particular purpose. The word is derived from the Greek word ''organon'', which means tool or instrument, musical instrument, and organ. Types There are a variety of legal types of organizations, including corporations, governments, non-governmental organizations, political organizations, international organizations, armed forces, charities, not-for-profit corporations, partnerships, cooperatives, and educational institutions, etc. A hybrid organization is a body that operates in both the public sector and the private sector simultaneously, fulfilling public duties and developing commercial market activities. A voluntary association is an organization consisting of volunteers. Such organizations may be able to operate without legal formalities, depending on jurisdiction, includ ...
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Miscommunication
Miscommunication ("''mis''" + "''communication''") is defined as a social inability to communicate adequately and properly. It is one of many types of communication barriers. It is an instant where either the speaker is unable to provide the proper and adequate information to the hearer or the hearer misperceived and couldn't recognise the communication from the speaker. The cases of miscommunication vary depending on the situation and persons included in it, but often result in confusion and frustration. In some cases, miscommunication may even open up the triangle of other factors that inevitably leads to a conflict. Miscommunication is a lack of alignment of agents' intellectual state, especially when they diverge on the outcomes of communication. The type of miscommunication can now be classified as to the source of the non-alignment about the communicative act.{{Cite journal, last=Clark, first=Herbert H., date=1994-12-01, title=Managing problems in speaking, journal=Speech ...
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Industry Regulation
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions ...
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Military
A military, also known collectively as armed forces, is a heavily armed, highly organized force primarily intended for warfare. It is typically authorized and maintained by a sovereign state, with its members identifiable by their distinct military uniform. It may consist of one or more military branches such as an army, navy, air force, space force, marines, or coast guard. The main task of the military is usually defined as defence of the state and its interests against external armed threats. In broad usage, the terms ''armed forces'' and ''military'' are often treated as synonymous, although in technical usage a distinction is sometimes made in which a country's armed forces may include both its military and other paramilitary forces. There are various forms of irregular military forces, not belonging to a recognized state; though they share many attributes with regular military forces, they are less often referred to as simply ''military''. A nation's military may ...
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United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ...
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United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and Northern Ireland. The United Kingdom includes the island of Great Britain, the north-eastern part of the island of Ireland, and many smaller islands within the British Isles. Northern Ireland shares a land border with the Republic of Ireland; otherwise, the United Kingdom is surrounded by the Atlantic Ocean, the North Sea, the English Channel, the Celtic Sea and the Irish Sea. The total area of the United Kingdom is , with an estimated 2020 population of more than 67 million people. The United Kingdom has evolved from a series of annexations, unions and separations of constituent countries over several hundred years. The Treaty of Union between the Kingdom of England (which included Wales, annexed in 1542) and the Kingdom of Scotland in 170 ...
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Philippines
The Philippines (; fil, Pilipinas, links=no), officially the Republic of the Philippines ( fil, Republika ng Pilipinas, links=no), * bik, Republika kan Filipinas * ceb, Republika sa Pilipinas * cbk, República de Filipinas * hil, Republika sang Filipinas * ibg, Republika nat Filipinas * ilo, Republika ti Filipinas * ivv, Republika nu Filipinas * pam, Republika ning Filipinas * krj, Republika kang Pilipinas * mdh, Republika nu Pilipinas * mrw, Republika a Pilipinas * pag, Republika na Filipinas * xsb, Republika nin Pilipinas * sgd, Republika nan Pilipinas * tgl, Republika ng Pilipinas * tsg, Republika sin Pilipinas * war, Republika han Pilipinas * yka, Republika si Pilipinas In the recognized optional languages of the Philippines: * es, República de las Filipinas * ar, جمهورية الفلبين, Jumhūriyyat al-Filibbīn is an archipelagic country in Southeast Asia. It is situated in the western Pacific Ocean and consists of around 7,641 islands t ...
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International Council On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ...
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Triage
In medicine, triage () is a practice invoked when acute care cannot be provided for lack of resources. The process rations care towards those who are most in need of immediate care, and who benefit most from it. More generally it refers to prioritisation of medical care as a whole. In its acute form it is most often required on the battlefield, during a pandemic, or at peacetime when an accident results in a mass casualty which swamps nearby healthcare facilities' capacity. Triage always follows the modern interpretation of the Hippocratic oath, but otherwise there is plenty of leeway in interpretation, leading to more than one simultaneous idea of its nature. The best settled theories and practical scoring systems used in here come from the area of acute physical trauma in an emergency room setting; a broken bone obviously counts for less than uncontrolled arterial bleeding, apt to lead to death. But no current principle carries too well over to mental health, reproductive heal ...
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ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has b ...
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Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ...
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