Clinical Research Dictionary
(Glossary of Terms and Acronyms)
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| Clinical Research Dictionary |
| (Glossary of Terms and Acronyms) |
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| 7 Days (in relation to IRBMED) | See Seven Days (in relation to IRBMED) | ||
| 15 days (in relation to IRBMED) | The IRBMED office should receive reports within fifteen business days of the event or investigator's receipt of notification of the event. (Because the reporting of adverse events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to adverse event notifications and reports from subjects, sponsors and other sources.) | ||
| 45 CFR 46 | Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects. Most recently updated in June 1991 (Subpart B in 2002), these regulations govern human subjects research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subjects research today. | ||
| 356H | See Marketing Application (as FDA Form) | http://forms.psc.gov/forms/MSWFDA/FDA-356h.doc | |
| 482 | See Notice of Inspection (as FDA Form) | ||
| 483 | See Inspectional Observations (as FDA Form) | ||
| 510K | See Pre Market Notification | ||
| 1571 | See Investigational New Drug Application (as FDA Form) | http://forms.psc.gov/forms/MSWFDA/FDA-1571.doc | |
| 1572 | See Statement of Investigator (as FDA Form) | 21 CFR 312.53 http://forms.psc.gov/forms/MSWFDA/FDA-1572.doc |
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| 3454 | See Financial Disclosure (as FDA Forms) | 21 CFR 54.4 http://forms.psc.gov/forms/MSWFDA/FDA-3454.doc |
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| 3455 | See Financial Disclosure (as FDA Forms) | 21 CFR 54.4 http://forms.psc.gov/forms/MSWFDA/FDA-3455.doc |
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| 3500A | See Med Watch Form (as FDA Form) | http://www.fda.gov/medwatch/safety /3500a.pdf |
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| 501.c.3 | Internal Revenue Service tax exempt status for non-profit organizations | ||
| 7471 (Form) | Project Budget Form: This form should be used to allocate or reallocate budget amounts for sponsored projects. It is necessary to complete this form any time Financial Operations has assigned an amount to the "Budget to be Allocated" budget category (999998). | ||
| A-21 | OMB Circular A-21 - Cost principles for educational institutions. | ||
| A-110 | OMB Circular A-110 - Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals or other non-profit organizations. | ||
| A-133 | OMB Circular A-133 - Audits of states, local governments & non-Profit organizations. | ||
| Abbreviated Antibiotic Drug Application | AADA | A marketing application usually reserved for antibiotics (e.g., generics), which duplicate products previously approved under a full marketing application. This application is “abbreviated” since reports of non-clinical studies and clinical studies (except bioavailability) may be omitted. | |
| Abbreviated New Drug Application | ANDA | A marketing application usually reserved for drug products (e.g., generics), which duplicate products previously approved under a full marketing application. This application is “abbreviated” since reports of non-clinical studies and clinical studies (except bioavailability) may be omitted. | |
| Abnormal Pre-clinical Finding | A finding in a pre-clinical animal or in-vitro study that suggests a significant risk for human subjects, including reports of mutagenicity, tetratogenicity, or carcinogenicity (21 CFR 312.32 (c)(2)); or findings of contamination in vaccines or other administered agents. Sometimes referred to as an “abnormal laboratory finding,” this reportable event does not refer to a value outside the normal range of values for routine clinical laboratory tests. Such lab results that refer a particular subject should be reported to the extent that they are a part of an event that would be categorized as an adverse event overall and/or when unexpected patterns are noted across subjects. | ||
| Absorption (in relation to Pharmacokinetics) | The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. See also ADME |
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| Absorption, Distribution, Metabolism, Excretion/Elimination | ADME | Used to describe pharmacokinetic processes. See Pharmacokinetic |
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| Abuse (Personal) | When another person does something on purpose that causes you mental or physical harm or pain. | ||
| Abuse-Liable | Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines). | ||
| Accelerated Approval | A highly specialized mechanism within the Food and Drug Administration that is intended to speed approval of drugs promising significant benefit over existing therapy for serious or life threatening illnesses. | ||
| Accessibility of Services | Your ability to get medical care and services when you need them. | ||
| Accreditation | A process whereby a program of study or an institution is recognized by an external body as meeting certain predetermined standards. | ||
| Accountability (in relation to Investigational Product) |
Process and documents such that investigational product(s) have been used according to the protocol (i.e., Required documentation for quantity used and left over, and date of disposal). | ICH E6 8.3.23 | |
| Accounting for Disclosures | Information that describes a covered entity's disclosures of PHI other than for treatment, payment, and health care operations; disclosures made with Authorization; and certain other limited disclosures. For those categories of disclosures that need to be in the accounting, the accounting must include disclosures that have occurred during the 6 years (or a shorter time period at the request of the individual) prior to the date of the request for an accounting. However, PHI disclosures made before the compliance date for a covered entity are not part of the accounting requirement. | ||
| Accreditation | An evaluative process in which a healthcare organization undergoes an examination of its policies, procedures and performance by an external organization ("accrediting body") to ensure that it is meeting predetermined criteria. It usually involves both on- and off-site surveys. | ||
| Accural | Enrollment of eligible subjects into a clinical trial. | ||
| Acquired Immune Deficiency Syndrome | AIDS | A disease of the human immune system that is characterized cytologically especially by a reduction in the numbers of CD4-bearing helper T cells to 20 percent or less of normal thereby rendering the subject highly vulnerable to life-threatening conditions (as Pneumocystis carinii pneumonia) and to some that become life-threatening (as Kaposi's sarcoma) and that is caused by infection with HIV commonly transmitted in infected blood especially during illicit intravenous drug use and in bodily secretions (as semen) during sexual intercourse See also SIDA and HIV in acronym glossary. | |
| Act (in terms of Regulation) | The Federal Food, Drug, and Cosmetic Act of the United States. | 21 CFR 312.3 | |
| Act/Law/Statute | Term for legislation that passed through Congress and was signed by the President or passed over his veto. | ||
| Action Letter | An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter. | ||
| Active Control (in terms of Subject) | Subjects who are randomly assigned to either a recognized effective treatment or the study drug. | ||
| Active Control | Any pharmaceutical formulation incorporating a chemical or biological substance with a known efficacy which is provided to an investigator for use in a clinical investigation as a basis for comparison with one or more treatments. | ||
| Active Treatment Concurrent Control | See Active Treatment Control | ||
| Active Treatment Control (in terms of Subject) | Subjects who are randomly assigned to a recognized effective treatment. | ||
| Activity Code (in terms of NIH) | A code assigned by the National Institutes of Health (NIH) that identifies support mechanisms and includes, but is not limited to, categories such as research grants, contracts, training, and fellowships. | http://grants.nih.gov/grants/funding/ac.pdf | |
| Active Ingredient | See Active Moiety | ||
| Active IND Status | Generally, an active IND is one under which clinical investigations are being conducted. | ||
| Active Moiety | The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance. | ||
| Active Subjects | Generally considered as any person (patient or subject) participating in a clinical trial who is actively receiving study treatment. | ||
| Active Treatment | 1. Any pharmaceutical formulation (or dosage form) incorporating a chemical or biological substance. This will include, but is not limited to active controls, or concurrent medications whether specified by clinical protocol or not. 2. Purely clinical, i.e., non-pharmaceutical, interventions whether specified by clinical protocol or not. |
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| Activity Chart | Term used by investigators, CRAs, and data managers for the chronological display of specific study activities. This chart assists the investigator in managing subjects at various stages in the protocol. Also known as a study evaluation / procedure table or chart and/or a study / vist schedule. | ||
| Acute Myocardial Infarction | AMI | A heart attack. The term "myocardial infarction" focuses on the heart muscle, which is called the myocardium, and the changes that occur in it due to the sudden deprivation of circulating blood. This is usually caused by arteriosclerosis with narrowing of the coronary arteries, the culminating event being a thrombosis (clot). The main change is death (necrosis) of myocardial tissue. | |
| Addendum (to the Protocol) | See Protocol Amendment | ||
| Adequate and Well Controlled (in relation to Clinical Trial) | Phase 3 trials, which provide the substantial evidence of effectiveness and safety upon which the investigational product is approved. | 21 CFR 314.126 | |
| Adjuvant Therapy | Therapy provided to enhance the effect of an primary therapy; auxiliary therapy. | ||
| ADME Studies | Studies to investigate how the body absorbs, distributes, metabolizes, and excretes a drug. | ||
| Administrative Regulations | Regulations that implement: 1.) guidance from the Office of Management and budget (OMB) contained in circulars that apply to the administration of all federal grants and cooperative agreements; 2.) Presidential Executive Orders (where regulation is necessary); and 3.) legislation that affects all applicants for or recipients of federal grants and cooperative agreements; see also EDGAR (defined below). | ||
| Administrative Shell | The parts of a formal proposal that typically includes the PAF, sponsor cover sheet (signed), budget & justification, abstract, and sponsor's checklist. | ||
| Administrative Simplification | Title II, Subtitle F, of HIPAA which authorizes HHS to: 1.) adopt standards for transactions and code sets that are used to exchange health data; 2.) adopt standard identifiers for health plans, health care providers, employers, and individuals for use on standard transactions; and 3.) adopt standards to protect the security and privacy of personally identifiable health information. | ||
| Administrative Simplification Compliance Act | Signed into law on December 27, 2001 as Public Law 107-105, this Act provides a one-year extension to HIPAA “covered entities” (except small health plans, which already have until October 16, 2003) to meet HIPAA electronic and code set transaction requirements. Also, allows the Secretary of HHS to exclude providers from Medicare if they are not compliant with the HIPAA electronic and code set transaction requirements and to prohibit Medicare payment of paper claims received after October 16, 2003, except under certain situations. | ||
| Admission Criteria | Criteria essential for selecting a target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of study-specific inclusion criteria and that none of their characteristics match exclusion criteria established for the study. See also Exclusion Criteria and Inclusion Criteria |
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| Admission Date | The date the patient was admitted for inpatient care, outpatient service, or start of care. For an admission notice for hospice care, enter the effective date of election of hospice benefits. | ||
| Advanced Registered Nurse Practioner | See Nurse Practitioner | ||
| Adverse Drug Event (in relation to ICH) | ADE | See Adverse Drug Reaction (in relation to ICH) | |
| Adverse Drug Reaction (in relation to ICH) | ADR | In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. | ICH E6 1.1 |
| Adverse Drug Reaction | ADR | A reaction which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In the case of clinical trials, injuries by overdosing, abuse / dependence, and interactions with other medicinal products should be considered as an ADR. | |
| Adverse Drug Reaction On-line Information Tracking - Electronically Generated Information Service | ADROIT - AEGIS | Medicines and Healthcare products Regulatory Agency’s Adverse Drug Reaction On-line Information Tracking - Electronically Generated Information Service. | http://medicines.mhra.gov.uk Click on Information Resources |
| Adverse Event (in relation to ICH) | AE | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | ICH E6 1.2 |
| Adverse Event (in relation to IRBMED) | Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio. Note that the Food and Drug Administration also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g. a bacteria is identified in a culture from the same batch of cells used to produce a vaccine which has been administered, even if no cases of infection have been reported). |
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| AE Database | A collection of adverse event data that is organized for efficient storage, search and retrieval. | ||
| Adverse Experience (in relation to ICH) | AE | See Adverse Event (in relation to ICH) | |
| Advertisement (for Subject Recruitment) | A document such that recruitment measures are appropriate and not coercive. | ICH E6 8.2.3 | |
| Advisory Committee | Food and Drug Administration established committee that consists of clinical experts and one consumer advocate (not employed by the FDA) in designated drug classes and subspecialties who are asked to consider data presented in marketing applications (e.g., new drug applications) and to advise as to whether there exists evidence of safety and effectiveness based upon adequate and well controlled studies. | ||
| Advisory Council on Clinical Research | ACCR | A UM advisory body initiated in 1997 as part of the program of Academic Support Funds supporting new faculty initiatives within the Medical School. | http://www.med.umich.edu/medschool /orgs/accr/ |
| Agency for Healthcare Research and Quality (NIH) | AHRQ | AHRQ, a part of the U.S. Department of Health and Human Services, is the lead agency charged with supporting research designed to improve the quality of healthcare, reduce its cost, improve patient safety, decrease medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on healthcare outcomes; quality; and cost, use, and access. The information helps healthcare decision makers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of healthcare services. | |
| Agreement (between involved parties) | A document for agreements between 2 parties. Examples include, but are not limited to: investigator / institution and sponsor, investigator / institution and CRO, sponsor and CRO, investigator / institution and regulatory authorities. | ICH 8.2.6 | |
| Agreement (in relation to OHRP) | 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 that assures institutional compliance with and implementation of regulations (i.e., 45 CFR Pat 46) for the protection of human subjects. | ||
| Agreement for an Independent Investigator (in relation to OHRP) | AII | 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 that assures compliance with and implementation of regulations (i.e., 45 CFR Pat 46) for the protection of human subjects. It exists for use when a non-CPRP (Cooperative Protocol Research Program) performance site does not involve an institution. | |
| AIDS Clinical Trials Group (NIAID) | ACTG | The largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the United States and the developed world. The AACTG has been pivotal in providing the data necessary for the approval of therapeutic agents, as well as the treatment and prevention strategies, for many opportunistic infections and malignancies. The AACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research. | |
| Aim of a Study | The objective of a clinical trial. | ||
| Albumin | One of a class of simple proteins in the blood. The level of albumin may reflect the amount of protein intake in food. | ||
| Alcohol, Drug Abuse, and Mental Health Administration | ADAMHA | Reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA included the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of the National Institutes of Health (NIH). See also SAMHSA. | |
| Algorithm | Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach an outcome. | ||
| Aliquot | A part that is a definite fraction of a whole, as in aliquot samples for laboratory testing or analysis. | ||
| Alpha Error | See Type 1 Error | ||
| Alternate Hypothesis | The opposite of a null hypothesis. See Null Hypothesis and Research Hypothesis |
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| Ambulatory Care | All types of health services that do not require an overnight hospital stay. | ||
| Ambulatory Care Sensitive Conditions | ACSC conditions are medical conditions for which physicians broadly concur that a substantial proportion of cases should not advance to the point were hospitalization is needed if they are treated in a timely fashion with adequate primary care and managed properly on an outpatient basis. | ||
| Ambulatory Surgical Center | A place other than a hospital that does outpatient surgery. At an ambulatory (in and out) surgery center, you may stay for only a few hours or for one night. | ||
| Amendment (to the protocol) | See Protocol Amendment | ICH E6 1.3 | |
| Amendment | A change to an approved clinical protocol which significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. May also include administrative or minor changes, which as changes in company personnel, spelling errors, etc. | ||
| American Academy of Pharmaceutical Physicians | AAPP | The American Academy of Pharmaceutical Physicians is a non-profit association dedicated to: Enhancing the proficiency of pharmaceutical physicians; Promoting the acquisition and dissemination of knowledge concerning the therapeutic action, investigation, and development of medicines and diagnostics; Protecting the welfare of patients and study subjects. The Association of Clinical Research Professionals (ACRP) and the American Academy of Pharmaceutical Physicians (AAPP) have announced that the Boards of both organizations have signed a Memorandum of Understanding signifying a formal affiliation between the two groups and their related Education Foundation activities. In this affiliation, AAPP joins with ACRP to be the single global organization that will unify, certify and educate, all members of the Clinical Research Team. | http://aapp.org/ |
| American Association for Homecare | AAHomecare | An industry association for the home care industry, including home IV therapy, home medical services and manufacturers, and home health providers. AAHomecare was created through the merger of the Health Industry Distributors Association's Home Care Division (HIDA Home Care), the Home Health Services and Staffing Association (HHSSA), and the National Association for Medical Equipment Services (NAMES). | http://www.aahomecare.org/ |
| American Association for the Advancement of Science | AAAS | An international non-profit organization dedicated to advancing science around the world by serving as an educator, leader, spokesperson and professional association. In addition to organizing membership activities, AAAS publishes the journal Science, as well as many scientific newsletters, books and reports, and spearheads programs that raise the bar of understanding for science worldwide. | http://www.aaas.org/ |
| American Association of Animal Laboratory Accreditation Council | AAALAC | AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. | http://www.aaalac.org/ |
| American Association of Blood Banks | AABB | AABB is an international, not-for-profit association dedicated to the advancement of science and the practice of transfusion medicine and related biological therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs and services that optimize patient and donor care and safety. | http://www.aabb.org/ |
| American Association of Medical Colleges | AAMC | The Association of American Medical Colleges is a nonprofit association of medical schools, teaching hospitals, and academic societies. The AAMC seeks to improve the nation's health by enhancing the effectiveness of academic medicine. | http://www.aamc.org/ |
| American Association of Pharmaceutical Scientists | AAPS | AAPS is a professional, scientific society of more than 12,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development. | http://www.aapspharmaceutica.com/index.asp |
| American Cancer Society | ACS | The American Cancer Society is the nationwide community- based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service. | http://www.cancer.org/ |
| American College of Clinical Pharmacology | ACCP | The objectives of the College are to advance the science of clinical pharmacology in all its phases and to engage in appropriate educational efforts in the public interest. These goals are to be attained in a manner consistent with the highest ethical and scientific standards. | http://www.accp1.org/ |
| American Council for Learned Societies | ACLS | The mission of the American Council of Learned Societies, as set forth in its constitution, is to "advance humanistic studies in all fields of learning in the humanities and the social sciences and to maintain and strengthen relations among the national societies devoted to such studies." As the pre-eminent representative of humanities scholarship in America, the ACLS carries out its mission in a variety of programs across many fields of learning. Awarding peer-reviewed fellowships is at the core of ACLS activity. While it is difficult to catalogue concisely the wide range of ACLS activities, the many other forms of the Council's work fall under the twin goals of its mission. | http://www.acls.org/ |
| American Council on Education | ACE | The major coordinating body for all the nation's higher education institutions, seeks to provide leadership and a unifying voice on key higher education issues and to influence public policy through advocacy, research, and program initiatives. | http://www.acenet.edu |
| American Dental Association | ADA | A professional organization for dentists. The ADA maintains a hardcopy dental claim form and the associated claim submission specifications, and also maintains the Current Dental Terminology (CDT...) medical code set. The ADA and the Dental Content Committee (DeCC), which it hosts, have formal consultative roles under HIPAA. | |
| American Federation for Clinical Research | AFCR | See American Federation for Medical Research | |
| American Federation for Medical Research | AFMR | Formerly the American Federation for Clinical Research. The AFMR is an international multi-disciplinary association of scientists engaged in all areas of biomedical investigation-patient-oriented, translational, and basic research. Members are located at government facilities, medical centers, research institutions, and private industry in all 50 states and throughout the world. AFMR fosters research in the medical sciences, provides leadership in articulating and publicizing the aims and goals of scientific research, disseminates the knowledge medical research generates, and identifies and supports efforts to achieve these objectives. | http://www.afmr.org/ |
| American Foundation for AIDS Research | AmFAR | Formerly the American Federation for Clinical Research. The AFMR is an international multi-disciplinary association of scientists engaged in all areas of biomedical investigation-patient-oriented, translational, and basic research. Members are located at government facilities, medical centers, research institutions, and private industry in all 50 states and throughout the world. AFMR fosters research in the medical sciences, provides leadership in articulating and publicizing the aims and goals of scientific research, disseminates the knowledge medical research generates, and identifies and supports efforts to achieve these objectives. | http://www.amfar.org |
| American Health Information Management Association | An association of health information management professionals. AHIMA sponsors some HIPAA educational seminars. | ||
| American Heart Association | AHA | The American Heart Association is a national voluntary health agency whose mission is to reduce disability and death from cardiovascular diseases and stroke. | http://www.americanheart.org |
| American Hospital Association | A health care industry association that represents the concerns of institutional providers. The AHA hosts the NUBC, which has a formal consultative role under HIPAA. | http://www.aha.org | |
| American Medical Association | AMA | As the national professional organization for all physicians, the AMA serves as the steward of medicine and leader of the medical profession. The AMA’s envisioned future is to be an essential part of the professional life of every physician and an essential force for progress in improving the nation’s health. Only the AMA has the national voice, the reputation and the stature to be a strong advocate for physicians and their patients. Through active advocacy at all levels of the private and public sectors, we are working to protect the patient-physician relationship, which is at the heart of medicine. Advocacy takes many forms, including public health initiatives, legislation, marketplace interventions and strengthening physician leverage in negotiations. | http://www.ama-assn.org/ |
| American Medical Informatics Association | A professional organization that promotes the development and use of medical informatics for patient care, teaching, research, and health care administration | http://www.amia.org/ | |
| American National Standards | Standards developed and approved by organizations accredited by ANSI. | ||
| American National Standards Institute | ANSI | An organization that accredits various standards-setting committees, and monitors their compliance with the open rule-making process that they must follow to qualify for ANSI accreditation. HIPAA prescribes that the standards mandated under it be developed by ANSI-accredited bodies whenever practical. | http://www.ansi.org/ |
| American Pharmaceutical Association | APhA | The APhA, the national professional society of pharmacists, founded in 1852 as the American Pharmaceutical Association, is the first-established and largest professional association of pharmacists in the United States. The more than 50,000 members of APhA include practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. The Association is a leader in providing professional information and education for pharmacists and an advocate for improved health of the American public through the provision of comprehensive pharmaceutical care. | http://www.aphanet.org |
| American Society for Clinical Pharmacology and Therapeutics | ASCPT | The ASCPT was founded in 1900, and consists of over 1,900 professionals whose primary interest is to promote and advance the science of human pharmacology and therapeutics. The Society is the largest scientific and professional organization serving the Discipline of Clinical Pharmacology. | http://www.ascpt.org/ |
| American Society for Quality | ASQ | Formerly American Society for Quality Control. The ASQ, is the world’s leading authority on quality since 1946. The 104,000-member professional association creates better workplaces and communities worldwide by advancing learning, quality improvement, and knowledge exchange to improve business results. By making quality a global priority, an organizational imperative, and a personal ethic, ASQ becomes the community for everyone who seeks technology, concepts, or tools to improve themselves and their world. | http://www.asq.org |
| American Society for Testing and Materials | ASTM | A standards group that has published general guidelines for the development of standards, including those for health care identifiers. ASTM Committee E31 on Healthcare Informatics develops standards on information used within healthcare. | |
| American Standard Code for Information Interchange | ASCII | American Standard Code for Information Interchange is a code that uses seven bits to represent standard text characters as well as a number of terminal control characters such as line feed, carriage return and so on. American Standard Code for Information Interchange (pronounced "askey") is one of the two common computer codes. | |
| Americans with Disabilities Act | ADA | An act to establish a clear and comprehensive prohibition of discrimination on the basis of disability. | http://www.usdoj.gov/crt/ada/adahom1.htm |
| Analyte | A substance being analyzed; in chromatography, a single component (compound) of a mixture. | ||
| Anatomical Therapeutic Classification Code | ATC Code | A classification system provided by the World Health Organization (WHO) for drug terms that describes the body system and main therapeutic use. | |
| Ancillary Services | Professional services by a hospital or other inpatient health program. These may include x-ray, drug, laboratory, or other services. | ||
| Anemia | A condition occurring when the blood is deficient in red blood cells and/or hemoglobin which decrease the oxygen carrying capacity of the blood. | ||
| Anesthesia | Drugs that a person is given before surgery so he or she will not feel pain. Anesthesia should always be given by a doctor or a specially trained nurse. | ||
| Annual Reports (in relation to INDs) | A brief report with specific of the progress of an investigation submitted by a sponsor to the FDA within 60 days of the anniversary date that the Investigational New Drug Application went into effect. | 21 CFR 312.33 | |
| Annual Reports (in relation to IRBs) | Summary reports provided yearly to IRB. | ICH E6 8.3.19 | |
| Annual Reports (in relation to NDAs) | Reports that are completed by the holder of the New Drug Application (NDA) for the responsible FDA reviewing division within 60 days of the anniversary date for the NDA such that the FDA is provided with a means of ongoing monitoring of the drug's safety and quality. | ||
| Annual Review (in relation to IRBs) | See Annual Report (in relation to IRBs) | ||
| Anonymity | Pertains to the information that an individual has disclosed in a study with the expectation that the information has no identifiers linked to the participant and therefore cannot in any way be traced to the participant. "Anonymity" and "confidentiality" do not have the same meaning and are not interchangeable. | ||
| Applet | An application that has limited features, requires limited memory resources, and is usually portable between operating systems. A Java application; an application program that uses the client's web browser to provide a user interface. A small application, typically downloaded from a server. | ||
| Applicable Regulatory Requirement(s) | Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where a trial is conducted. | ICH E6 1.4 | |
| Applicant (in relation to FDA) | Any person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application. | 21 CFR 314.3 | |
| Application (in relation to IRBMED) | See New Project Application or Emergency Use Application | ||
| Application (in relation to NIH) | A request for financial support of a project/activity submitted to National Institutes of Health (NIH) on specified forms and in accordance with NIH instructions. | http://grants1.nih.gov/grants/forms.htm | |
| Application Control Center | The area of the Department of Educational [in the Grants and Contracts Service (defined below)] that is officially authorized to receive applications for discretionary grants and cooperative agreements. | ||
| Application Notice | A notice published in the Federal Register that invites applications for one or more discretionary grant or cooperative agreement competitions, gives basic program and fiscal information on each competition, informs potential applicants when and where they can obtain applications, and cites the deadline date (defined below), for a particular competition. | ||
| Application Package | A package that contains the application notice for one or more programs and all the information and forms needed to apply for a discretionary grant or cooperative agreement. | ||
| Applied Clinical Trials magazine | ACT | Applied Clinical Trials is the authorative, peer-reviewed resource and thought leader for the global community that designs, initiates, manages, conducts, and monitors clinical trials. Industry professionals learn effective and efficient solutions to strategic and tactical challenges within the tightly regulated, highly competitive pharmaceutical environment. | http://www.actmagazine.com /appliedclinicaltrials/ |
| Applied Research Ethics National Association | ARENA | The membership division of Public Responsibility in Medicine and Research (PRIM&R). | |
| Appointment/Visit Deviation | A scheduling deviation is a reportable occurrence if and when a procedure or intervention did not take place in accordance with the time frame established in the protocol for safety and/or scientific purposes of testing and evaluation. Note: protocol descriptions of treatment(s) to be administered, dosing schedule(s), treatment period(s), and follow-up period(s) should reflect reasonable flexibility in accordance with sound experimental design. | ICH 6.6.1 | |
| Appropriations Legislation | A law passed by the Congress to provide a certain level of funding for a grant program in a given year. | ||
| Approvable Action Letter | The FDA sends an approvable letter if the application substantially meets the requirements for marketing approval and the agency believes it can approve the application if specific additional information or material is submitted, or if specific conditions are agreed to by the applicant. The sponsor has ten days after the date of issuance of an approvable letter to respond to the FDA regarding the requested changes. | ||
| Approvable Letter (in relation to Marketing Applications) | A written communication to an applicant from FDA stating that the agency will approve the application or abbreviated application if specific additional information or material is submitted or specific conditions are met. An approvable letter does not constitute approval of any part of an application or abbreviated application and does not permit marketing of the drug that is the subject of the application or abbreviated application. | 21 CFR 314.3 | |
| Approved or approval (in relation to FDA) | Before doctors can use new medications or devices, the Food and Drug Administration (FDA) must approve them. The FDA bases its decisions on the safety and effectiveness of the new product from preclinical studies on animals or laboratory tests and on clinical trials on humans. Some clinical trials test approved drugs for new uses, while others test unapproved drugs. | ||
| Approval (in relation to IRBs) | The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. | ICH E6 1.5 | |
| Approval Action Letter | A subject drug is considered approved for market as of the date of the FDA approval letter, with no or minor changes to the application. | ||
| Approval Letter (in relation to Marketing Applications) | A written communication to an applicant from FDA approving an application or an abbreviated application. | 21 CFR 314.3 | |
| Archival | See Data Archival | ||
| Area Agency On Aging | AAA | State and local programs that help older people plan and care for their life-long needs. These needs include adult day care, skilled nursing care/therapy, transportation, personal care, respite care, and meals. | |
| Arm (in terms of Clinical Trial) | See Study Arm | ||
| Army Research Office | ARO | The U.S. Army Research Office (ARO) mission is to seed scientific and far reaching technological discoveries that enhance Army capabilities. Basic research proposals from educational institutions, nonprofit organizations, and private industry are competitively selected and funded. ARO's research mission represents the most long-range Army view for changes in its technology. It is the only Army organization that transcends all of its mission areas: commander-fire support; close combat; air defense; combat support; combat service support; solider support; command, control, and communications. In all respects, the ARO program is the designated organization for the entire spectrum of Army activities extending from research to development to acquisition. ARO priorities fully integrate Army-wide, long-range planning for research, development, and acquisition. | http://www.aro.army.mil/ |
| Assent | A child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. | 21 CFR 50.3 45 CFR 46.402 (b) |
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| Assessment Schedule | The schedule for conducting clinical examinations and observations used for assessing the safety and efficacy of a study drug. Also refers to the schedule of examinations and observations for assessing whether subjects fit inclusion/exclusion criteria. | ||
| Assisted Living | A type of living arrangement in which personal care services such as meals, housekeeping, transportation, and assistance with activities of daily living are available as needed to people who still live on their own in a residential facility. In most cases, the "assisted living" residents pay a regular monthly rent. Then, they typically pay additional fees for the services they get. | ||
| Associated with the Use of the Drug (in relation to AEs) | A reasonable possibility that the experience may have been caused by the drug. | 21 CFR 312.32 | |
| Association for the Accreditation of Human Research Protection Programs | AAHRPP | A nonprofit organization that offers accreditation using a voluntary, peer-driven educational model to institutions engaged in research involving human participants. | http://www.aahrpp.org/ |
| Association of American Medical Colleges | AAMC | The Association of American Medical Colleges is a nonprofit association of medical schools, teaching hospitals, and academic societies. The AAMC seeks to improve the nation's health by enhancing the effectiveness of academic medicine. The AAMC assists academic medicine's institutions, organizations and individuals in three main mission areas: Medical Education - Educating the physician and medical scientist workforce; Medical Research - Discovering new medical knowledge. Developing innovative technologies for the prevention, diagnosis and treatment of disease; Patient Care - Providing health care services in academic settings. | http://www.aamc.org/ |
| Association of American Universities | AAU | The Association of American Universities (AAU) was founded in 1900 by a group of fourteen universities offering the Ph.D. degree. The AAU currently consists of sixty American universities and two Canadian universities. The association serves its members in two major ways. It assists members in developing national policy positions on issues that relate to academic research and graduate and professional education. It also provides them with a forum for discussing a broad range of other institutional issues, such as undergraduate education. | http://www.aau.edu/ |
| Association of Clinical Research Organizations | ACRO | The Association of Clinical Research Organizations (ACRO) represents a growing community of CROs on a global scale. ACRO focuses on industry-wide issues that evolve with ongoing advances in pharmaceutical and biologic research. ACRO members dedicated themselves to the continued development of breakthrough medical products, and offer a wide range of research and development services that help pharmaceutical and biotechnology companies develop new medicines for patients, touching millions to help improve lives. | http://acrohealth.org/ |
| Association of Clinical Research Professionals | ACRP | An international non-profit organization for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospitals, academic medical centers, and physician office settings. | http://www.acrpnet.org |
| Association of Official Analytical Chemists | AOAC | AOAC INTERNATIONAL is a 120 year-old not-for-profit scientific association committed to worldwide confidence in analytical results. In fact, “worldwide confidence in analytical results” is AOAC’s vision. To attain the vision, AOAC serves the communities of analytical sciences by providing the tools and processes necessary for community stakeholders to collaborate and, through consensus building, develop fit-for-purpose methods and services for assuring quality measurements. | http://www.aoac.org/ |
| Association of the British Pharmaceutical Industry | ABPI | The ABPI is the trade association for about a hundred companies in the UK producing prescription medicines. Its member companies research, develop, manufacture and supply more than 90 per cent of the medicines prescribed through the National Health Service (NHS). | http://www.abpi.org.uk/ |
| Assurance | A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy §___.103]. | ||
| Assurance (in relation to OHRP) | A document approved by OHRP from a prospective awardee or other institutional performance site to be engaged in Department of Health and Human Services conducted or supported research that assures institutional compliance with and implementation of regulations (i.e., 45 CFR Part 46) for the protection of human subjects. | ||
| Attribution | A determination made by the investigators about the cause of an adverse event, specifically whether an adverse event is or is not related to a test article or other research intervention. See also Cause and Relatedness. | ||
| Audit | A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). | ICH E6 1.6 | |
| Audit Certificate | Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). | ICH E6 1.7 | |
| Audit Funding | A conclusion about a monetary or nonmonetary matter related to an auditor's examination of an organization, program, activity, or function, which frequently identifies problems and provides recommendations for correction action in order to prevent their future recurrence. | ||
| Audit Report | A written evaluation by the sponsor's auditor of the results of the audit. | ICH E6 1.8 | |
| Audit Resolution Process | The process by which the Department determines whether costs under a grant that have been identified in an audit report as questioned or unsupported are actually allowable or unallowable and initiates action to have recipients return unallowable expenditures. | ||
| Audit Trail | The documentation of events at each step of a clinical trial process. Used by auditors to trace the source and to determine the authenticity of clinical trial data. | ICH E6 1.9 | |
| Authorization (in relation to HIPAA) | An individual's written permission to allow a covered entity to use or disclose specified PHI for a particular purpose. Except as otherwise permitted by the rule, a covered entity may not use or disclose PHI for research purposes without a valid authorization. | ||
| Authorized Institutional Official | AIO | The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. | |
| Autonomy (in terms of subject) | Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. | ||
| Autopsy | Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts. | ||
| Award (in terms of NIH) | The provision of funds by NIH, based on an approved application and budget, to an organizational entity or an individual to carry out an activity or project. | ||
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