Term
|
Definition
| American Association for the Advancement of Science |
|
|
Term
|
Definition
| American Association of Blood Banks |
|
|
Term
|
Definition
| Abbreviated Antibiotic Drug Application (FDA) (used primarily for generics) |
|
|
Term
|
Definition
| Association of American Medical Colleges |
|
|
Term
|
Definition
| American Association of Pharmaceutical Scientists |
|
|
Term
|
Definition
| Association of the British Pharmaceutical Industry |
|
|
Term
|
Definition
| American College of Clinical Pharmacology |
|
|
Term
|
Definition
| Association for Clinical Data Management (UK) |
|
|
Term
|
Definition
| Angiotensin-converting enzyme |
|
|
Term
|
Definition
| A national trade association representing independent, commercial scientific, and engineering firms |
|
|
Term
|
Definition
| Association of Clinical Pharmacology Units |
|
|
Term
|
Definition
| Associate Commissioner for Regulatory Affairs (FDA) |
|
|
Term
|
Definition
| Association of Clinical Research Professionals |
|
|
Term
|
Definition
| Changed its name to ICR- Institute of Clinical Research |
|
|
Term
|
Definition
| Applied Clinical Trials magazine |
|
|
Term
|
Definition
| AIDS Clinical Trials Group (NIAID) |
|
|
Term
|
Definition
| AIDS Clinical Trials Unit (NIH) |
|
|
Term
|
Definition
| Analysis Data Model (a CDISC standard) |
|
|
Term
|
Definition
| Adverse Drug Event/Experience |
|
|
Term
|
Definition
| Absorption, distribution, metabolism, and excretion (pharmacokinetics) |
|
|
Term
|
Definition
| Adverse Drug Reaction- any noxious and unintended response associated with the use of a drug in humans |
|
|
Term
|
Definition
| Adverse Event- any untoward medical occurrence in subjects which does not necessarily have a casual relationship with the treatment |
|
|
Term
|
Definition
| ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from Adverse Drug Reaction Online Information Tracking database |
|
|
Term
|
Definition
| Adverse Even Reporting System (FDA) |
|
|
Term
|
Definition
| American Federation for Medical Research (formerly American Federation for Clinical Research AFCR) |
|
|
Term
|
Definition
| American Heart Association |
|
|
Term
|
Definition
| Agency for Health Care Policy Research (NIH) |
|
|
Term
|
Definition
| American Health Information Community |
|
|
Term
|
Definition
| Association of Independent Clinical Research Contractors (UK) |
|
|
Term
|
Definition
| Acquired immune deficiency syndrome, acquired immunodeficiency syndrome |
|
|
Term
|
Definition
| Attributable, legible, contemporaneous, original, accurate (dimensions of data integrity) |
|
|
Term
|
Definition
|
|
Term
|
Definition
| American Medical Association |
|
|
Term
|
Definition
| Antibody-mediated cytotoxicity |
|
|
Term
|
Definition
| American Foundation for AIDS research |
|
|
Term
|
Definition
| Arzneimittelgesetz (German Drug Law) |
|
|
Term
|
Definition
| American Medical Writers Association |
|
|
Term
|
Definition
| Abbreviated New Drug Application (for generic drug) |
|
|
Term
|
Definition
| Analysis of variance (statistics) |
|
|
Term
|
Definition
| American National Standards Institute- coordinator for US voluntary standards efforts, acts as approval body to recognize documents developed by other national organizations, acts as US representative in international and regional standards efforts, and serves as a clearinghouse for national and international standards development information |
|
|
Term
|
Definition
| Association of Official Analytical Chemists |
|
|
Term
|
Definition
| Association Pharmaceutique Belge (Belgium) |
|
|
Term
|
Definition
| American Pharmacists Association |
|
|
Term
|
Definition
| active pharmaceutical ingredient |
|
|
Term
|
Definition
| Academy of Pharmaceutical Physicians and Investigators |
|
|
Term
|
Definition
| Association of Regulatory & Clinical Scientists (Australia) |
|
|
Term
|
Definition
| academic research organizaiton |
|
|
Term
|
Definition
| Administrative Systems Automation Project (FDA) |
|
|
Term
|
Definition
| American Standard Code for Information Interchange (computer files) |
|
|
Term
|
Definition
| American Society for Clinical Pharmacology and Therapeutics |
|
|
Term
|
Definition
| application service provider delivering a computer application via the www |
|
|
Term
|
Definition
| American Society for Quality (formerly American Society for Quality Control) |
|
|
Term
|
Definition
| Anatomic-Therapeutic Chemical Coding dictionary |
|
|
Term
|
Definition
| area under the curve (statistics) |
|
|
Term
|
Definition
| An official communication from FDA to an NDA sponsor announcing an agency decision- includes approval, not approval, clinical hold and warning letters |
|
|
Term
|
Definition
| Enabling an eClinical trial system to capture data; usually used for EDC systems |
|
|
Term
|
Definition
| basis for selecting target population for a clinical trial |
|
|
Term
|
Definition
| step-by-step procedure for solving a mathematical problem |
|
|
Term
|
Definition
| the likelihood that a relationship observed between 2 variables is due to chance |
|
|
Term
|
Definition
| an organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to database table |
|
|
Term
|
Definition
| set of subjects whose data are to be included in the main analyses- should be defined in the statistical section of the protocol |
|
|
Term
|
Definition
| variables used to test the statistical hypotheses identified in the protocol; variables to be analyzed |
|
|
Term
|
Definition
| designation for a planned activity, often marking the transition between epochs or elements of a clinical plan |
|
|
Term
|
Definition
| personal data which have been processed to be made anonymous |
|
|
Term
|
Definition
| a small application, typically downloaded from a server |
|
|
Term
|
Definition
| 1. Computer software designed to fill users' needs 2. Regulatory application- made to a health authority to investigate, market or license a new product or indication |
|
|
Term
|
Definition
| An official communication from FDA to an NDA/BLA sponsor that lists issues to be resolved before an approval can be issued |
|
|
Term
| approval (in relation to IRBs) |
|
Definition
| Affirmative decision of the IRB that the clinical trial has bene reviewed and may be conducted within the constraints set forth by the IRB, the institution, GCP and regulatory requirements |
|
|
Term
|
Definition
| An official communication from FDA to inform an application of decision to allow commercial marketing consistent with conditions of approval |
|
|
Term
|
Definition
| a planned sequence of elements, typically equivalent to a treatment group |
|
|
Term
|
Definition
| a measurement evaluation, or judgement fr a study variable pertaining to the status of a subject |
|
|
Term
|
Definition
| in data modeling, refers to specific items of data that can be collected for a class |
|
|
Term
|
Definition
| a systematic and independent examination of trial-related activities and documents to determine whether they were done according to protocol, SOPs, GCP and regulatory requirements |
|
|
Term
|
Definition
| a document certifying that the audit has taken place |
|
|
Term
|
Definition
| a written evaluation by the auditor of the results of the audit |
|
|
Term
|
Definition
| a process that captures details such as additions, deletions, or alterations of information in an electronic record- facilitates the reconstruction of the history of such actions |
|
|
Term
|
Definition
| translating a document back that had been translated to another language |
|
|
Term
|
Definition
| information pertinent to the understanding of a protocol |
|
|
Term
|
Definition
| trial in which a particular type of subject is equally represented in each study group |
|
|
Term
|
Definition
| indicator of the throughput (speed) of data flow on a transmission path |
|
|
Term
|
Definition
| assessment of subjects as they enter a trial and before they receive any treatment |
|
|
Term
|
Definition
| demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered |
|
|
Term
|
Definition
| systematic error in creating intervention groups, such that they differ with respect to prognosis (participants are not representative of the population of all possible participants) |
|
|
Term
|
Definition
| approaches to data analysis that provide a posterior probability distribution for some parameter derived from the observed data and a prior probability distribution for the parameter- used as the basis for statistical inference |
|
|
Term
|
Definition
| statistical approach named for Thomas Bayes, accepting the idea that it is possible to talk about the probability of hypotheses being true and parameters having particular values |
|
|
Term
|
Definition
| probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis |
|
|
Term
|
Definition
| situation or condition that causes the result to depart from the true value in a consistent direction |
|
|
Term
|
Definition
| methods for quantitative measurement of a drug, metabolites, or chemicals in biological fluids |
|
|
Term
|
Definition
| rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body |
|
|
Term
|
Definition
| scientific basis on which drugs with the same active ingredients are compared |
|
|
Term
|
Definition
| Biologics Licensing Application- application to FDA for a license to market a new biologic product in the US |
|
|
Term
|
Definition
| a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention |
|
|
Term
|
Definition
| branch of statistics applied to the analysis of biological phenomena |
|
|
Term
|
Definition
| checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis |
|
|
Term
| blinded (masked) medications |
|
Definition
| made impossible to distinguish whether active or placebo is being administered |
|
|
Term
|
Definition
| the subject, investigator, or anyone assessing the outcome is unaware of the treatment assignments |
|
|
Term
|
Definition
| a procedure to limit bias by preventing subjects and study personnel from identifying which treatments or procedures are administered |
|
|
Term
|
Definition
| point within a study where there is an allocation of subject subsets to particular procedures or treatment groups |
|
|
Term
|
Definition
| computer program that runs on the user's desktop to navigate the world wide web |
|
|
Term
|
Definition
| British Association of Research Quality Assurance |
|
|
Term
|
Definition
| beneficial clinical event |
|
|
Term
|
Definition
| Bureau of Drug Policy and Administration (China) |
|
|
Term
|
Definition
| European Bureau of Consumer Unions |
|
|
Term
|
Definition
| Federal Institute for Drugs and Medical Devices, Germany |
|
|
Term
|
Definition
| Federal health office, former German public health agency |
|
|
Term
|
Definition
| Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany |
|
|
Term
|
Definition
| Biotechnology industry Organization |
|
|
Term
|
Definition
| British Institute of Regulatory Affairs |
|
|
Term
|
Definition
| Biologics License Application (FDA) |
|
|
Term
|
Definition
| Bundesverband der Pharmazeutischen Industrie EV (Germany) |
|
|
Term
|
Definition
| British Association of Pharmaceutical Physicians |
|
|
Term
|
Definition
| Biomedical Research Integrated Domain Group |
|
|
Term
|
Definition
|
|
Term
|
Definition
| A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or "substantially equivalent" to a legally marketed device |
|
|
Term
|
Definition
|
|
Term
|
Definition
| American Chemical Society |
|
|
Term
|
Definition
| a drug component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease |
|
|
Term
|
Definition
| product containing any filthy, putrid, or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; etc |
|
|
Term
|
Definition
| Association of Food and Drug Officials |
|
|
Term
|
Definition
| Active Implantable Medical Device Directive |
|
|
Term
|
Definition
| Application Integrity Policy. FDA's approach to reviewing applications that may be affected by wrongful acts that raise significant questions regarding data reliability |
|
|
Term
|
Definition
| Abbreviated New Animal Drug Application |
|
|
Term
|
Definition
| American Psychological Association |
|
|
Term
|
Definition
| Animal and Plant Health Inspection Service |
|
|
Term
|
Definition
| FDA designation given to drugs, biologics and medical devices that have been granted marketing approval |
|
|
Term
|
Definition
|
|
Term
|
Definition
| American Society for Microbiolgoy |
|
|
Term
|
Definition
| Bureau of Alcohol, Tobacco and Firearms |
|
|
Term
|
Definition
| Bulk Activities Chemical Post Approval Changes |
|
|
Term
|
Definition
| device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health |
|
|
Term
|
Definition
| any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries in man |
|
|
