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Standard Operating Procedures
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 United States, U.S. and the United Kingdom, UK) use the term standing 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 on Harmonisation of Technical Requirements ...
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Organization
An organization or organisation (English in the Commonwealth of Nations, Commonwealth English; American and British English spelling differences#-ise, -ize (-isation, -ization), see spelling differences) is an legal entity, entity—such as a company, or corporation or an institution (formal organization), or an Voluntary association, association—comprising one or more person, people and having a particular purpose. Organizations may also operate secretly or illegally in the case of secret society , secret societies, criminal organizations, and resistance movements. And in some cases may have obstacles from other organizations (e.g.: Southern Christian Leadership Conference, MLK's organization). What makes an organization recognized by the government is either filling out Incorporation (business), incorporation or recognition in the form of either societal pressure (e.g.: Advocacy group), causing concerns (e.g.: Resistance movement) or being considered the spokesperson o ...
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ISO 9001
The ISO 9000 family is a set of international standards for quality management systems. It was developed in March 1987 by International Organization for Standardization. The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The standards were designed to fit into an integrated management system. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary 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. A companion document, ISO/TS 9002, provides guidelines ...
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Pharmaceutical Industry
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or for alleviating symptoms of illness or injury. Pharmaceutical companies may deal in generic drugs, branded drugs, or both, in different contexts. Generic materials are without the involvement of intellectual property, whereas branded materials are protected by chemical patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics and total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, ...
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Military Terminology
Military terminology refers to the terminology, terms and language of military organizations, military personnel, personnel, and military doctrine. Much like other forms of corporate jargon, military terminology is distinguishable from colloquial language by its use of new or repurposed words and phrases typically only understandable by current and former members of the military or associated companies and agencies. Common understanding The operational pressure for uniform understanding has developed since the early 20th century with the importance of Joint warfare, joint operations between different services (army, navy, air force) of the same country. International alliances and operations, including peacekeeping, have added additional complexity. For example, the NATO alliance now maintains a large dictionary of common terms for use by member countries. Development work is also taking place between NATO and Russia on common terminology for extended air defence, in English, Fre ...
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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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Good Clinical Practice
In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly develope ...
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Safety Science
''Safety Science'' is a monthly peer-reviewed scientific journal published by Elsevier covering research on all aspects of human and industrial safety. The editor-in-chief is Georgios Boustras ( European University Cyprus),. The journal was established in 1976 as the ''Journal of Occupational Accidents'', with Herbert Eisner as founding editor-in-chief. In 1990, the aims and scope of the journal were expanded, and the journal obtained its current name. Editors-in-chief Since 1990, the following persons are or have been editors-in-chief: * 1990–2009: Andrew Hale * 2010–2012: Kathryn Mearns * 2013–2017: Jean-Luc Wybo * 2018–present: Georgios Boustras Abstracting and indexing The journal is abstracted and indexed in: According to the ''Journal Citation Reports'', the journal has a 2023 impact factor The impact factor (IF) or journal impact factor (JIF) of an academic journal is a type of journal ranking. Journals with higher impact factor values are considered more ...
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Job Safety Analysis
A job safety analysis (JSA) is a procedure that helps integrate accepted safety and health principles and practices into a particular task or job operation. The goal of a JSA is to identify potential hazards of a specific role and recommend procedures to control or prevent these hazards. Other terms often used to describe this procedure are job hazard analysis (JHA), hazardous task analysis (HTA) and job hazard breakdown. The terms "job" and "task" are commonly used interchangeably to mean a specific work assignment. Examples of work assignments include "operating a grinder," "using a pressurized water extinguisher" or "changing a flat tire." Each of these tasks have different safety hazards that can be highlighted and fixed by using the job safety analysis. Terminology and definitions ;Workplace hazard categories Workplace hazards can be allocated to six categories: * Safety hazards: Ex. spills, working from heights, confined spaces * Biological hazards: Ex. bodily fluids, ani ...
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Triage
In medicine, triage (, ; ) is a process by which care providers such as Health professional, medical professionals and those with first aid knowledge determine the order of priority for providing treatment to injured individuals and/or inform the rationing of limited supplies so that they go to those who can most benefit from it. Triage is usually relied upon when there are more injured individuals than available care providers (known as a mass casualty incident), or when there are more injured individuals than supplies to treat them. The methodologies of triage vary by institution, locality, and country but have the same universal underlying concepts. In most cases, the triage process places the most Major trauma, injured and most able to be helped as the first priority, with the most Terminal illness, terminally injured the last priority (except in the case of reverse triage). Triage systems vary dramatically based on a variety of factors, and can follow specific, measurable me ...
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Miscommunication
Miscommunication ("''mis''" + "''communication''") is the failure of communicating clearly the intended message or idea. It may be a social inability to communicate adequately and properly, and it is one of many types of communication barriers. It is an instance 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 ...
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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 " ove all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s, the European Union began harmonising regulatory requir ...
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Philippines
The Philippines, officially the Republic of the Philippines, is an Archipelagic state, archipelagic country in Southeast Asia. Located in the western Pacific Ocean, it consists of List of islands of the Philippines, 7,641 islands, with a total area of roughly 300,000 square kilometers, which are broadly categorized in Island groups of the Philippines, three main geographical divisions from north to south: Luzon, Visayas, and Mindanao. With a population of over 110 million, it is the world's List of countries and dependencies by population, twelfth-most-populous country. The Philippines is bounded by the South China Sea to the west, the Philippine Sea to the east, and the Celebes Sea to the south. It shares maritime borders with Taiwan to the north, Japan to the northeast, Palau to the east and southeast, Indonesia to the south, Malaysia to the southwest, Vietnam to the west, and China to the northwest. It has Ethnic groups in the Philippines, diverse ethnicities and Culture o ...
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