Clinical
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Clinical
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| Named-Patient Prescribing | (UK) The release of an investigational drug for administration to a single subject. | ||
| National Aeronautics and Space Administration | NASA | Since its inception in 1958, NASA has accomplished many great scientific and technological feats in air and space. NASA technology also has been adapted for many nonaerospace uses by the private sector. NASA remains a leading force in scientific research and in stimulating public interest in aerospace exploration, as well as science and technology in general. Perhaps more importantly, our exploration of space has taught us to view Earth, ourselves, and the universe in a new way. While the tremendous technical and scientific accomplishments of NASA demonstrate vividly that humans can achieve previously inconceivable feats, we also are humbled by the realization that Earth is just a tiny "blue marble" in the cosmos. | http://www.nasa.gov/ |
| National Academy of Sciences | NAS | A private, non-profit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. | http://www4.nationalacademies.org /nas/nashome.nsf |
| National Association for Biomedical Research | NABR | The National Association for Biomedical Research (NABR) is the only national, nonprofit organization dedicated solely to advocating sound public policy that recognizes the vital role of humane animal use in biomedical research, higher education and product safety testing. | http://www.nabr.org/ |
| National Association Of Health Data Organizations | A group that promotes the development and improvement of state and national health information systems. | ||
| National Association Of Insurance Commissioners | NAIC | An association of the insurance commissioners of the states and territories. | |
| National Association of IRB Managers | NAIM | An independent human research management organization based in Atlanta, Georgia, not formally associated with any agency, government body or school. | http://www.naim.org/ |
| National Bioethics Advisory Commission | NBAC | See President's Council on Bioethics | |
| National Cancer Institute | NCI | An institute within the NIH that leads a national effort to reduce the burden of cancer morbidity and mortality. | http://www.nci.nih.gov/ |
| National Center for Complementary and Alternative Medicine (NIH) | NCCAM | Formerly Office of Alternative Medicine. NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine (CAM) researchers, and disseminating authoritative information to the public and professionals. | http://nccam.nih.gov/ |
| National Center for Health Statistics (in CDC) | NCHS | The mission of NCHS is to provide statistical information that will guide actions and policies to improve the health of the American people. As the Nation's principal health statistics agency, NCHS leads the way with accurate, relevant, and timely data. | http://www.cdc.gov/nchs/ |
| National Center for Human Genome Research (NIH) | NCHGR | The National Human Genome Research Institute began as the NCHGR, which was established in 1989 to carry out the role of the National Institutes of Health (NIH) in the International Human Genome Project (HGP). The HGP was developed in collaboration with the United States Department of Energy (DOE) and begun in 1990 to map the human genome. In 1993, NCHGR expanded its role on the NIH campus by establishing the Division of Intramural Research (DIR) to apply genome technologies to the study of specific diseases. In 1996, the Center for Inherited Disease Research (CIDR) was also established (co-funded by eight NIH institutes and centers) to study the genetic components of complex disorders. | http://www.genome.gov/ |
| National Center for Research Resources | NCRR | A component of the National Institutes of Health that supports primary research to create and develop critical resources, models, and technologies and funds biomedical researchers to provide them with access to diverse instrumentation, technologies, basic and clinical research facilities, animal models, genetic stocks, biomaterials, and more in order to enable scientific advances in biomedicine that lead to the development of lifesaving drugs, devices, and therapies. | http://www.ncrr.nih.gov/ |
| National Childhood Vaccine Injury Act (1986) | NCVIA | The topic of vaccine safety became prominent during the mid 1970's with increases in lawsuits filed on behalf of those presumably injured by the diphtheria, pertussis, tetanus (DPT) vaccine. Legal decisions were made and damages awarded despite the lack of scientific evidence to support vaccine injury claims. As a result of the liability, prices soared and several manufacturers halted production. A vaccine shortage resulted and public health officials became concerned about the return of epidemic disease. In order to reduce liability and respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986. | http://www.cdc.gov/nip /vacsafe/ |
| National Commission | See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research | ||
| National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research | Created on July 12, 1974 as a result of the signing of the National Research Act into law such that one of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines (e.g., Belmont Report) which should be followed to assure that such research is conducted in accordance with those principles. | ||
| National Committee for Clinical Laboratory Standards | NCCLS | A globally recognized, voluntary consensus standards-developing organization that enhances the value of medical testing within the healthcare community through the development and dissemination of standards, guidelines, and best practices. | http://www.nccls.org/ |
| National Committee for Quality Assurance | NCQA | An independent, non-profit organization whose mission is to improve health care quality including programs: 1.) oversight on the accreditation of human research protection programs for Veterans Affairs Medical Centers; and 2.) partnership with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to form the Partnership for Human Research Protection. | http://www.ncqa.org/index.asp |
| National Committee on Vital and Health Statistics | NCVHS | A Federal advisory body within HHS that advises the Secretary regarding potential changes to the HIPAA standards. To advise on shaping a national information strategy for improving the population’s health. | http://www.ncvhs.hhs.gov/ |
| National Council For Prescription Drug Programs | An ANSI-accredited group that maintains a number of standard formats for use by the retail pharmacy industry, some of which have been adopted as HIPAA standards. | http://www.ncpdp.org/ main_frame.htm |
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| National Council of University Research Administrators | NCURA | NCURA serves its members and advances the field of research administration through education and professional development programs, the sharing of knowledge and experience, and by fostering a professional, collegial, and respected community. | http://www.ncura.edu/ |
| National Council on Patient Information and Education (Washington, DC) | NCPIE | NCPIE is a coalition of over 125 diverse organizations whose mission is to stimulate and improve communication of information on appropriate medicine use to consumers and healthcare professionals. NCPIE is the nation's leading authority for informing the general public and health care professionals on safe medicine use through better communication. Better medicine communication can lead to better health outcomes and improved quality of life. | http://www.talkaboutrx.org /index.jsp |
| National Drug Code | A medical code set maintained by the FDA that contains codes for drugs that are FDA-approved. The Secretary of HHS adopted this code set as the standard for reporting drugs and biologics on standard transactions. | ||
| National Endowment for the Arts | NEA | The NEA enriches our Nation and its diverse cultural heritage by supporting works of artistic excellence, advancing learning in the arts, and strengthening the arts in communities throughout the country. | http://arts.endow.gov/ |
| National Endowment for the Humanities | NEH | NEH is an independent grant-making agency of the United States government dedicated to supporting research, education, preservation, and public programs in the humanities. | http://www.neh.fed.us/ |
| National Eye Institute (NIH) | NEI | The NEI was established by Congress in 1968 to protect and prolong the vision of the American people. As one of the Federal government's NIH, the NEI conducts and supports research that helps prevent and treat eye diseases and other disorders of vision. This research leads to sight-saving treatments, reduces visual impairment and blindness, and improves the quality of life for people of all ages. NEI-supported research has advanced our knowledge of how the visual system functions in health and disease. | http://www.hud.gov/ |
| National Formulary | NF | (US) An integral part of the US Pharmacopoeia (USP), which covers pharmaceutical ingredients. |
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| National Heart, Lung and Blood Institute (NIH) | NHLBI | The NHLBI provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects. Research is related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The NHLBI plans and directs research in development and evaluation of interventions and devices related to prevention, treatment, and rehabilitation of patients suffering from such diseases and disorders. It also supports research on clinical use of blood and all aspects of the management of blood resources. Research is conducted in the Institute's own laboratories and by scientific institutions and individuals supported by research grants and contracts. | http://www.nhlbi.nih.gov/ |
| National Human Research Protection Advisory Committee | NHRPAC | Former DHHS committee that provided expert advice and recommendations to the Secretary of HHS, Assistant Secretary for Health (ASH), the Director, Office for Human Research Protections (OHRP), and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects. | http://ohrp.osophs.dhhs.gov /nhrpac/nhrpac.htm |
| National Institute of Allergies and Infectious Diseases (NIH) | NIAID | The NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. | http://www.niaid.nih.gov /default.htm |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) | NIAMS | The mission of the NIAMS is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases. | http://www.niaid.nih.gov /default.htm |
| National Institute of Child Health and Human Development (NIH) | NICHD | The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation. | http://www.nichd.nih.gov/ |
| National Institute of Dental and Craniofacial Research | NIDCR | The mission of the NIDCR is to improve oral, dental and craniofacial health through research, research training, and the dissemination of health information. We accomplish our mission by: Performing and supporting basic and clinical research; Conducting and funding research training and career development programs to ensure an adequate number of talented, well-prepared and diverse investigators; Coordinating and assisting relevant research and research-related activities among all sectors of the research community; Promoting the timely transfer of knowledge gained from research and its implications for health to the public, health professionals, researchers, and policy-makers. | http://www.nidcr.nih.gov/ |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIH) | NIDDK | The NIDDK conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields as well as many basic science disciplines. | http://www.niddk.nih.gov/ |
| National Institute of Environmental Health Sciences (NIH) | NIEHS | Human health and human disease result from three interactive elements: environmental factors, individual susceptibility and age. The mission of the NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate. The NIEHS achieves its mission through multidisciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. | http://www.niehs.nih.gov/ |
| National Institute of General Medical Sciences (NIH) | NIGMS | The NIGMS primarily supports basic biomedical research that lays the foundation for advances in disease diagnosis, treatment, and prevention. The Institute's training programs help provide the most critical element of good research: well-prepared scientists. NIGMS is one of the NIH, the principal biomedical research agency of the Federal Government. NIH is a component of the U.S. Department of Health and Human Services. NIGMS is organized into divisions and a center that support research and research training in basic biomedical science fields. One division has the specific mission of increasing the number of underrepresented minority biomedical and behavioral scientists. | http://www.nigms.nih.gov/ |
| National Institutes of Health | NIH | This DHHS agency is one of the world's foremost medical research centers, and the Federal focal point for medical research in the United States. | http://www.nih.gov/ |
| National Institute of Nursing Research (NIH) | NINR | The NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span-from management of patients during illness and recovery to the reduction of risks for disease and disability, the promotion of healthy lifestyles, promoting quality of life in those with chronic illness, and care for individuals at the end of life. | http://ninr.nih.gov/ninr/ |
| National Institute of Occupational Safety and Health | NIOSH | The federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is part of the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services. | http://www.cdc.gov/niosh /homepage.html |
| National Institute on Alcohol Abuse and Alcoholism (NIH) | NIAAA | NIAAA provides leadership in the national effort to reduce alcohol-related problems by: Conducting and supporting research in a wide range of scientific areas including genetics, neuroscience, epidemiology, health risks and benefits of alcohol consumption, prevention, and treatment; Coordinating and collaborating with other research institutes and Federal Programs on alcohol-related issues; Collaborating with international, national, state, and local institutions, organizations, agencies, and programs engaged in alcohol-related work; Translating and disseminating research findings to health care providers, researchers, policymakers, and the public. | http://www.niaaa.nih.gov/ |
| National Institute on Deafness and Other Communication Disorders (NIH) | NIDCD | NIDCD is mandated to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, smell, taste, voice, speech, and language. The Institute also conducts and supports research and research training related to disease prevention and health promotion; addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders; and supports efforts to create devices which substitute for lost and impaired sensory and communication function. | http://www.nidcd.nih.gov/ |
| National Institute on Drug Abuse (NIH) | NIDA | NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction. NIDA supported science addresses the most fundamental and essential questions about drug abuse, ranging from the molecule to managed care, and from DNA to community outreach research. | http://www.nida.nih.gov/ |
| National Library of Medicine (NIH) | NLM | The NLM, on the campus of the NIH in Bethesda, Maryland, is the world's largest medical library. The Library collects materials in all areas of biomedicine and health care, as well as works on biomedical aspects of technology, the humanities, and the physical, life, and social sciences. The collections stand at more than 7 million items--books, journals, technical reports, manuscripts, microfilms, photographs and images. Housed within the Library is one of the world's finest medical history collections of old and rare medical works. The Library's collection may be consulted in the reading room or requested on interlibrary loan. NLM is a national resource for all U.S. health science libraries through a National Network of Libraries of Medicine®. | http://www.nlm.nih.gov/ |
| National Research Act | United States Act created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent. | ||
| National Research Council | NRC | A private, nonprofit institution that is part of the National Academies and provides science, technology and health policy advice under a congressional charter. | http://www.nas.edu/nrc/ |
| National Science Foundation | NSF | An independent agency of the United States government that promotes the progress of science; advances the national health, prosperity, and welfare; and secures the national defense. | http://www.nsf.gov/ |
| National Security Agency | The National Security Agency/Central Security Service is America’s cryptologic organization. It coordinates, directs, and performs highly specialized activities to protect U.S. information systems and produce foreign intelligence information. A high technology organization, NSA is on the frontiers of communications and data processing. It is also one of the most important centers of foreign language analysis and research within the government. | http://www.nsa.gov/ home_html.cfm |
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| National Transportation Safety Board | NTSB | The NTSB is an independent Federal agency charged by Congress with investigating every civil aviation accident in the United States and significant accidents in the other modes of transportation -- railroad, highway, marine and pipeline -- and issuing safety recommendations aimed at preventing future accidents. | http://www.ntsb.gov/ |
| Nebulizers | Equipment to give medicine in a mist form to your lungs. | ||
| Negative Trial | A trial producing no therapeutic advantage for the investigational drug. | ||
| Neglect | When care takers do not give a person they care for the goods or services needed to avoid harm or illness. | ||
| Neonate | Newborn. | 45 CFR 46.202(d) | |
| New Chemical Entity | NCE | 1.) A pharmaceutic containing an active ingredient never before approved as a drug in the country concerned. 2.) A drug that contains no active ingredient that has been approved by a regulatory authority. Also called "New Molecular Entity (MCE)". |
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| New Drug Application | NDA | 1.) (US) The compilation of all information and data about a new drug, including nonclinical, clinical, pharmacological, pharmacokinetic and stability information, which is submitted to the FDA for review. The FDA must approve the NDA before the new drug can be marketed in the US. 2.) An application for a new drug product submitted to the FDA, specifically Center for Drug Evaluation and Research, under the Public Health Service Act for review and approval prior to marketing in interstate commerce. |
21 CFR 314.3 |
| New Drug Application Annual Report | NDAAR | See Annual Reports (in relation to NDAs) | |
| New Drug Application E-Submission | NDA E-sub | More current term for Computer-Assisted New Drug Application (CANDA) | |
| New Drug Application Summary | (US) Included in an NDA submission, it is an abridged version of the entire application and includes the application's claims, highlighting the studies and evidence supporting the drug's safety and efficacy. | ||
| New Drug Study | NDS | Canada’s new drug application. | |
| New England Journal of Medicine | NEJM | A weekly general medical journal that publishes new medical research findings, review articles, and editorials. | http://content.nejm.org/ |
| New Molecular Entity | NME | A medication containing an active substance that has never before been approved for marketing in any form by a regulatory authority. | |
| New Project Application (in relation to IRBMED) | An application specific to the IRBMED process at the University of Michigan. | ||
| NCR Paper | "No Carbon Required" paper that is used to produce multiple copies (e.g., 3) of each recorded page of a case report form (CRF). | ||
| Ninty-Day Conference | (US) Approximately 90 days after the FDA receives an NDA, the agency provides sponsors of certain drugs (generally, NMEs or major new indications of currently marketed drugs) the opportunity to meet with agency officials. The purpose of the meeting is to inform applicants of the general progress and status of their NDAs, and to advise them of deficiencies that have been identified but not yet communicated. | ||
| NLN Publication No. 28 | The basic GCP document that represents the consensus of the drug approval authorities in the Nordic countries: Denmark, Finland, Iceland, Norway, and Sweden. | ||
| No Action Indicated | NAI | FDA inspection classification indicating that the site inspected is in compliance and no action or response is necessary. | |
| No Carbon [Paper] Required | NCR | "No Carbon Required" paper that is used to produce multiple copies (e.g., 3) of each recorded page of a case report form (CRF). | |
| n-of-1 Study | A trial in an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment’s effect in that person, often with experimental and control treatments randomized. | ||
| Nonaffiliated Member (in relation to IRBs) | Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty and is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker). | ||
| Non Clinical Study | 1.) In vivo or in vitro experiments in which test articles are studied prospectively in test systems (i.e., any animal, plant, microorganism, or subparts) under laboratory conditions to determine their safety. 2.) Biomedical studies not performed on human subjects. |
21 CFR 58.3 | |
| ICH E6 1.41 | |||
| Non Comparative Study | A trial in which no comparative product is used (e.g., open label study) | ||
| Non-Critical Variable | Data that are not essential to answering the objectives of the study. A variable for which the computer entry of an incorrect value will not fundamentally affect the conclusions drawn from the results of the study. Usually used as supplemental, supportive data in listings. | ||
| Non Disclosure Agreements | Provide protection against misappropriation of non-public information (e.g., inventions, research data, computer software, etc.) Usually used prior to disclosing information to a company considering funding research and/or licensing technology. | ||
| Non-Evaluable for Efficacy | A subgroup of intent-to-treat subjects who do not satisfy the criteria for efficacy evaluation as set forth in the protocol statistical plan. | ||
| Non Institutional Investigator Agreement (in relation to OHRP) | NIA | A document approved by OHRP from a prospective awardee or other noninstitutional performance site tobe engaged in Department of Health and Human Services conducted or supported research. It assures compliance with and implementation of regulations (i.e., 45 CFR Pat 46) for the protection of human subjects. It also exists for use when a Cooperative Protocol Research Program (CPRP) performance site does not involve an institution. | |
| Non Invasive (in relation to devices or procedures) | Any procedure which does not involve the insertion of a piece of equipment or apparatus into a subject to take readings or to undertake assessments. | 21 CFR 812.3 | |
| Non Responder | A patient who does not respond (i.e., condition does not change or worsens) to the product or procedure. | ||
| Nonscientist Member (in relation to IRBs) | Member of an IRB who does not have a scientific background, but may be affiliated with the institution. | ||
| Non Significant Risk Device | NSR | A device that does not meet the definition of significant risk device. | |
| Non Therapeutic Research | Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future. | ||
| Non Therapeutic Study | A trial where there is no therapeutic benefit to the subject (e.g., Phase 1 study). | ||
| Non-Clinical Study | Biomedical studies not performed on human subjects. | ||
| Non-Governmental Organization | NGO | An organization that is not part of the local or state or federal government. | |
| Non-physiological Adverse Event | An adverse event involving social or psychological trauma, insult or injury rather than physiological or biomedical harm. |
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| Non-Small Cell Lung Carcinoma | NSCLC | Cancer of the lung which is not of the small cell carcinoma (oat cell carcinoma) type. The term "non-small cell lung cancer" applies to the various types of bronchogenic carcinomas (those arising from the lining of the bronchi) which include adenocarcinoma, squamous cell carcinoma, and large cell undifferentiated carcinoma. | |
| Nonviable Fetus | An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. See also Viable Infant. | ||
| Nonviable neonate | Neonate after delivery that, although living, is not viable | 45 CFR 46.202(e) | |
| Nordiska Lakemedelsnamnden | NLN | Swedish name for the Nordic Council on Medicines. | |
| Normal Lab Values | NLV | See Laboratory Reference Ranges | |
| Normal Volunteer | See Healthy Volunteer | ||
| North Central Cancer Treatment Group | NCCTG | (US) The NCCTG is a national clinical research group sponsored by the NCI. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States, Canada and Mexico. The research base for NCCTG is located at Mayo Clinic in Rochester, Minn. NCCTG is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live. NCCTG specializes in researching methods of treating and preventing cancer, and in researching methods to alleviate the side effects of cancer and cancer treatments. | http://ncctg.mayo.edu/ |
| Not Approvable Letter (in relation to Marketing Applications) | (US) A written communication to an applicant from FDA stating that the agency does not consider the application or abbreviated application approvable because one or more deficiencies in the application or abbreviated application preclude the agency from approving it. | 21 CFR 314.3 | |
| Notice of Adverse Findings | NAF | Official FDA correspondence (i.e., letter) indicates awareness of a violation that must be corrected. | |
| Notice of Inspection (as FDA Form) | Official FDA inspection form completed by FDA investigators and presented to the most responsible person (e.g., investigator) at the site being inspected at the start of any inspection type. | ||
| Notice of Outcome Review of Human Subject Research | A document issued by the University of Michigan IRBMED that provides status of approval of clinical research based on related documents (e.g., protocol, informed consent document) that were submitted. | ||
| Notified Body | NB | (UK) A private institution charged by the Competent Authority with verifying compliance with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB. | |
| No Treatment Control (in terms of Subject) | Subjects who are randomly assigned to no treatment (i.e., study drug or placebo). | ||
| Null Hypothesis | A null hypothesis is used to rule out every possibility except the one the researcher is trying to prove, an assumption about a research population that may or may not be rejected as a result of testing. Used because most statistical methods are less able to prove something true than to provide strong evidence that it is false. See also Equipoise and Research Hypothesis |
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| Nuremberg Code | A code of medical ethics for researchers conducting clinical trials set forth by the United States Military Tribunal in Nuremberg in 1947 as a result of the medical experimentation conducted by Nazis during World War II, and the code is designed to protect the safety and integrity of study participants. | ||
| Nurse Practitioner | NP | A nurse who has 2 or more years of advanced training and has passed a special exam. A nurse practitioner often works with a doctor and can do some of the same things a doctor does. | |
| Nursing Facility | A facility which primarily provides to residents skilled nursing care and relate services for the rehabilitation of injured, disabled, or sick persons, or on a regular basis, health related care services above the level of custodial care to other than mentally retarded individuals. | ||
| Nursing Home | A residence that provides a room, meals, and help with activities of daily living and recreation. Generally, nursing home residents have physical or mental problems that keep them from living on their own. They usually require daily assistance. | ||
| Nutrition | Getting enough of the right foods with vitamins and minerals a body needs to stay healthy. Malnutrition, or the lack of proper nutrition, can be a serious problem for older people. | ||
| O | |||
| Objective Measurement | A measurement that cannot be influenced by investigator bias (e.g., blood glucose levels or ECG tracings). | ||
| Observational Study | A study in which the investigators do not manipulate the use of an intervention (e.g., do not randomize patients to treatment and control groups), but only observe patients who are (and sometimes patients who are not) exposed to the intervention, and interpret the outcomes. | ||
| Observational Study Monitoring Board | OSMB | National Institute of Health-appointed board that monitors study progress and makes recommendations regarding appropriate protocol and operational changes for this type of study. | http://www.nhlbi.nih.gov/funding /policies/dsmb_est.htm |
| Occupational Safety and Environmental Health | OSEH | University of Michigan department through partnership, guidance, and education promotes health, safety, protection of the environment and regulatory compliance. | http://www.umich.edu/~oseh/ |
| Occupational Safety and Health Administration | OSHA | Agency within the United States Department of Labor whose mission is to prevent work-related injuries, illnesses, and deaths. | http://www.osha.gov/ |
| Occupational Therapy | OT | Services given to help you return to usual activities (such as bathing, preparing meals, housekeeping) after illness. | |
| Off Label Use | 1.) Use of a drug or device for an indication other than the one(s) described in the approved drug labeling or package insert. 2.) The use of an approved product (e.g., drug) to treat conditions other than those approved by a regulatory authority. |
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| Office For Civil Rights | OCR | The DHHS, through the OCR, promotes and ensures that people have equal access to and opportunity to participate in and receive services in all HHS programs without facing unlawful discrimination. Through prevention and elimination of unlawful discrimination, the OCR helps HHS carry out its overall mission of improving the health and well-being of all people affected by its many programs. This mission is communicated throughout the Department and is reflected in the customer service nondiscrimination objectives that have been developed in the Department's strategic plan. Ensuring the nondiscriminatory provision of services funded by or provided directly by the Department is a continuing challenge to all of the Department's employees. | http://www.hhs.gov/ocr/hipaa/ |
| Office of Biotechnology Activities | OBA | The NIH office responsible for developing, implementing, and monitoring NIH policies and procedures for the safe conduct of recombinant DNA activities, including human gene transfer. | http://www4.od.nih.gov/oba/ |
| Office of Drug Evaluation and Research | ODER | Assures that safe and effective drugs are available to the American people, has gone through a functional and organizational metamorphosis since it began as a one-man operation to assess significant drug problems in the marketplace on the eve of the 1906 Pure Food and Drugs Act. | http://www.fda.gov/cder/ |
| Office of Extramural Research | OER | Focal point within the NIH for policies and guidelines for extramural research grants administration which include the development and implementation of NIH Grants Policy, monitoring of compliance with PHS policy on Humane Use and Care of Laboratory Animals, coordination of program guidelines, and development and maintenance of the information systems for grants administration. | |
| Office of Generic Drugs (CDER, formerly DGB) | OGD | The Office of Generic Drugs, part of FDA’s Center for Drug Evaluation and Research, employs about 200 highly skilled scientists and support personnel. These employees are dedicated to assuring that only safe, effective high-quality and equivalent generic drug products are approved for use by the health care community and consumers. Through review of data on proposed products, the Office of Generic Drugs assures that generic product will perform the same as their respective brand name reference products. In the same manner, generic manufacturing and packaging sites must pass all of the same quality standards as those of brand name drugs and the generic products must meet the same exacting specifications as any new innovator drug product. | http://www.fda.gov/cder/ogd/ |
| Office of Government Ethics | OGE | Formerly part of Office of Personnel Management, separate executive branch in 1989. | |
| Office of Human Research Protection | OHRP | One of the United States health agencies reporting to the Office of Public Health and Science within the Department of Health and Human Services that has general oversight on needs and issues related human subject protection. | http://ohrp.osophs.dhhs.gov/ |
| Office of Human Subjects Research | OHSR | An office within the National Institutes of Health established to help Intramural Research Program investigators understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects. | http://206.102.88.10/ ohsrsite/index.html |
| Office of Inspector General | OIG | The United States department that protects the integrity of Department of Health and Human Services (HHS) programs, as well as the health and welfare of the beneficiaries of those programs. | http://www.oig.hhs.gov/ |
| Office of Management and Budget | OMB | OMB's predominant mission is to assist the President in overseeing the preparation of the federal budget and to supervise its administration in Executive Branch agencies. In helping to formulate the President's spending plans, OMB evaluates the effectiveness of agency programs, policies, and procedures, assesses competing funding demands among agencies, and sets funding priorities. OMB ensures that agency reports, rules, testimony, and proposed legislation are consistent with the President's Budget and with Administration policies. | |
| Office of Naval Research | ONR | The ONR coordinates, executes, and promotes the science and technology programs of the United States Navy and Marine Corps through schools, universities, government laboratories, and nonprofit and for-profit organizations. It provides technical advice to the Chief of Naval Operations and the Secretary of the Navy and works with industry to improve technology manufacturing processes. | http://www.onr.navy.mil/ |
| Office of Orphan Products Development | OOPD | (US) The office responsible for administering the laws regarding orphan drugs. Founded in 1982, the office encourages orphan drug development by: 1.) awarding commerical incentives; 2.) coordinating the efforts of investigators and drug companies; 3.) acting as a mediator between orphan sponsors and the FDA's drug and biologic review divisions; 4.) administering a grant program; and 5.) performing other promotional and educational activities. | |
| Office of Protection for Research Risks | OPRR | Historical term for the Office of Human Research Protection. | |
| Office of Public Health and Science | OPHS | The United States department that serves as the advisor on matters involving the nation's public health and oversees Department of Health and Human Service’s U.S. Public Health Service (PHS). | http://www.osophs.dhhs.gov/ophs/ |
| Office of Regulatory Affairs | ORA | The ORA is the lead office for all Field activities of the Food and Drug Administration. ORA's highly trained staff provides the eyes, ears and the long arm of the agency that ensures the implementation of the FDA's high public health standards. | http://www.fda.gov/ora/ |
| Office of Research Compliance and Assurance | ORCA | The former primary component of Veterans Health Administration (VHA) component in advising the Under Secretary for Health on all matters affecting the integrity of research in the protection of human subjects and the welfare of laboratory animals, promoting enhancements in the ethical conduct of research in conformance with regulations and policies and investigating any allegations of research improprieties and scientific misconduct. |
http://www.va.gov/orca/ |
| Office of Research and Development (in relation to VHA) | VAR&D | The office within the Veterans Health Administration (VHA) that serves as its major center of research with the following four primary services: 1.) Cooperative Studies Program; 2.) Health Services Research and Development Service; 3.) Medical Research Service; and 4.) Rehabilitation Research and Development. | |
| Office of Research Integrity | ORI | One of the United States health agencies reporting to the Office of Public Health and Science within the Department of Health and Human Services that promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide by monitoring institutional investigations of research misconduct and facilitating responsible conduct of research through educational, preventative, and regulatory activities. | http://ori.dhhs.gov/ |
| Office of Research Oversight | ORO | Replaces the Office of Research Compliance and Assurance (ORCA) to serve as the primary Veterans Health Administration (VHA) office in advising the Under Secretary for Health on all matters of compliance and assurance regarding human subjects protections, animal welfare, research safety, and research misconduct. | http://www1.va.gov/oro/ |
| Office of Technology Transfer | OTT | The University of Michigan organization with a central office and two satellite offices in the Medical School and the College of Engineering responsible for the transfer of University technology to the marketplace. | http://www.techtransfer.umich.edu/ |
| Office of the Vice President of Research | OVPR | A University of Michigan department that supports and promotes the efforts of faculty, staff, and students to remain in the forefront of research, scholarship, and creative activity, and is responsible for policies and compliance with ethical conduct of research. | http://www.research.umich.edu/ |
| Official Action Indicated | OAI | FDA inspection classification indicating that the site inspected has violations severe enough to warrant immediate administrative actions and that re-inspection by FDA is likely. | |
| On Job/On Campus (Program) | OJ/OC | University of Michigan School of Public Health Master's Program in Clinical Research Design and Statistical Analysis Program was developed to provide a means for physicians, dentists, pharmacists, pharmacologists and others who are involved in clinical research to develop expertise in research design and statistical analysis appropriate to such research while remaining in their existing employment. | http://www.sph.umich.edu/biostat /programs/clinical-stat/ |
| On-Site | The location where a clinical study is conducted. It may or may not be the same location as the Investigator's office / consultation room. | ||
| Open Design | An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned. | ||
| Open Label (in relation to clinical trial) | 1.) A non-blinded trial in which all parties have knowledge of drug and dose being administered. (Phase I and II studies may be conducted on an open-label basis.) 2.)All parties (patient, investigator and sponsor) are informed (i.e., not blinded) of the drug and dose being administered in the clinical study. |
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| Open Label Extension Study | See Open Label (in relation to trial) | ||
| Open Study | See Open Label (in relation to trial) | ||
| Open System | An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. | 21 CFR 11.3 | |
| Opinion (in relation to Independent Ethics Committee) | The judgment and/or the advice provided by an Independent Ethics Committee (IEC). | ICH E6 1.42 | |
| Opinion Leader (in terms of Investigator) | A leading authority/individual (i.e., an international, national, or local expert) on a particular topic (e.g., disease, class of drugs). | ||
| Option Agreements | An option agreement typically gives a company the exclusive right to evaluate a technology for a short period of time prior to executing a full license agreement. In most cases, the option agreement provides for the company to reimburse UM's patent expenses. Options may also include research funding and nominal fees. | ||
| Optional Titration Design (Placebo-Controlled Titration to Endpoint) | A study design in which subjects are titrated until they reach a well-characterized favorable or unfavorable response, defined by dosing rules described in the protocol. This approach is most applicable to conditions where the response is reasonably prompt and is not an irreversible event. | ||
| Oral Consent | Written text describing what will be told to subjects when oral consent is necessary. | ||
| Orange Book | (US) The common name for an FDA publication entitled, "Approved Drug Products," which lists all prescription drugs approved for use in the US along with their respective manufacturers. | ||
| Original Medical Record | See Source Documents | ICH E6 1.43 | |
| Orphan Drug | 1.) An orphan drug is a product deemed entitled by the authorities to receive two incentives, tax advantages and marketing exclusivity. To qualify, a drug must meet five specific criteria. The product: a.) must be a drug, biologic, or antibiotic; b.) must have a sponsor that is testing or is planning to test the product for use in an rare disease or condition (in the US, a patient population of less than 200,000); c.) must not have been previously approved under an NDA or PLA for the disease or condition for which it is seeking orphan status; d.) must be shown to have an adequate pharmacologic rationale for use in the orphan indication; e.) and must not be the subject of a marketing application submitted prior to the filing of an orphan status request. 2.) Medications that treat rare medical conditions. Because so few people need these drugs, pharmaceutical companies might not recoup the cost of development them. So the FDA established an "orphan drug" category of medications; manufacturers receive financial incentives to develop such drugs. |
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| Orphan Drug Act of 1983 | (US) This act provides sponsor companies with certain benefits (tax breaks and limited exclusive license) for developing drugs designed to treat limited populations. See Orphan Drug |
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| Outcome | A result, condition or event associated with individual study subjects used to assess efficacy or risk. | ||
| Outcome and Assessment Information Set | A group of data elements that represent core items of a comprehensive assessment for an adult home care patient and form the basis for measuring patient outcomes for purposes of outcome-based quality improvement (OBQI). This assessment is performed on every patient receiving services of Home Health agencies that are approved to participate in the Medicare and/or Medicaid programs. | ||
| Outcome Data | Data that measure the health status of people enrolled in managed care resulting from specific medical and health interventions (e.g., the incident of measles among plan enrollees during the calendar year). | ||
| Outcome Indicator | An indicator that assesses what happens or does not happen to a patient following a process; agreed upon desired patient characteristics to be achieved; undesired patient conditions to be avoided. | ||
| Outcomes Research | OR | See Pharmacoeconomics | |
| Outlier (in terms of Data) |
Data points which lie a long way from the main body of similar data. | ||
| Outpatient | A patient who is receiving ambulatory care at a hospital or other facility without being admitted to the facility. | ||
| Outpatient Care | Medical or surgical care that does not include an overnight hospital stay. | ||
| Outpatient Hospital | A portion of a hospital which provides diagnostic, therapeutic (both surgical and non-surgical), and rehabilitation services to sick or injured persons who do not require hospitalization or institutionalization. Part of the Hospital providing services covered by SMI, including services in an emergency room or outpatient clinic, ambulatory surgical procedures, medical supplies such as splints, laboratory tests billed by the hospital, etc. | ||
| Outpatient Services | A service you get in one day (24 hours) at a hospital outpatient department or community mental health center. | ||
| Outpatient Study | An study in which patients are not admitted to a hospital or clinic. | ||
| Overhead | See Indirect Costs | ||
| Over-the-Counter Drug | OTC | Drug products that are available to consumers without a doctor’s written prescription | |
| Over-the-Counter Drug Labeling | OTC Labeling requirements are similar to those for prescription pharmaceuticals, with regard to content. However, because OTC products are self-prescribed, much of the essential information provided to the pharmacist or physician must be detailed on the outer package of the container of an OTC product. | ||
| Overview Document | Any summary report that combines information from two or more clinical studies (e.g., IND, NDA, MAA). | ||
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