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TERMS
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MEANING
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AAPS
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American Association of Pharmaceutical Scientists
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ACRP
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Association of Clinical Research Professionals
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ADE
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Adverse Drug Event; Adverse Drug Effect
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ADME
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Absorption, Distribution, Metabolism and Excretion (used to describe pharmacokinetic processes)
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ADR
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Adverse Drug Reaction
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Adverse Event (AE)
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Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
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AE
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Adverse Event
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Alpha error
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The likelihood that a relationship observed between 2 variables is due to chance. The probability of a Type 1 error.
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ANDA
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Abbreviated New Drug Application (for a generic drug – FDA, US)
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| Antagonist |
A drug or compound that opposes the physiological effects of another. |
| Antibiotic |
An organic substance of microbial origin that is either toxic to, or inhibits the growth of other organisms. Eg: Penicillin. Synthetic antibiotics (or 'antibacterials') also exist. |
| Antibody |
The body's protective mechanism against infection and disease. A protein molecule in the blood serum and other bodily fluids produced by the immune system in response to exposure to a foreign substance. |
| Antigen |
Substances capable of inducing a specific immune response and reacting with the products of that response. |
| Antisense |
A nucleic acid sequence that complements the coding sequence of DNA or mRNA. Antisense sequences may have therapeutic usage, particularly against some cancers. |
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API
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Active Pharmaceutical Ingredient
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| Assay |
A laboratory test or technique to identify and/or measure the amount of a particular substance in a sample, or to determine characteristics such as composition, purity, activity and weight. Used to determine whether drugs or chemicals have the desired effect in a living organism, outside an organism, or in an artificial environment. |
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ARCS
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Association of Regulatory and Clinical Scientists (Australia)
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Arm
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A planned sequence of elements typically equivalent to a treatment group.
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Audit
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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 requirements.
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Audit trail
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1. Documentation that allows reconstruction of the course of events.
2. A secure, time-stamped record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic study record.
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BARQA
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British Association of Research Quality Assurance
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Baseline assessment
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Assessment of subjects as they enter a trial and before they receive any treatment.
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Baseline characteristics
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Demographic, clinical and other data collected for each participant at the beginning of the trial before the intervention is administered.
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Beta error
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Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis.
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BfArM
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Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)
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Bias
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Situation or condition that causes a result to depart from the true value in a consistent direction. Bias refers to defects in study design or measurement.
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Bioanalytical assays
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Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.
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| Bioassay |
The determination of the biological activity of a drug by observing its effect on an organism (or organ) compared to a standard preparation. |
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Biochip
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An electronic device that uses organic molecules to form a semiconductor.
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Bioequivalence
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Scientific basis on which drugs with the same active ingredient(s) are compared.
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| Bioinformatics |
The use of computers in the life sciences, electronic databases of genomes and protein sequences, and computer modeling of biomolecules and biologic systems. |
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Biologic
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A therapeutic or prophylactic derived from a living source (human, animal or unicellular). Most biologics are complex mixtures that are not easily identified or characterized, and many are manufactured using biotechnology. A Biological product is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood (or component or derivative), allergenic product or analogous product applicable to the prevention, treatment or cure of diseases or injuries to humans.
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Biologics Licensing Application (BLA)
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An application to FDA for a license to market a new biologic product in the United States.
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Biomarker
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A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
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| Biopharmaceutical |
A biotechnologically produced substance such as proteins, nucleic acids and other naturally occurring compounds derived from living cells for pharmaceutical applications. |
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Biostatistics
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Branch of statistics applied to the analysis of biological phenomena.
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| Biotechnology |
The industrial use of living organisms (or parts thereof) to produce foods, drugs or other products |
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Blind review
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Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis.
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BLA
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Biologics Licensing Application
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Blinded (masked) medications
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Products that appear identical in size, shape, colour, flavour and other attributes to make it very difficult for subjects and investigators (or anyone assessing the outcome) to determine which medication is being administered.
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Blinded study
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A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s). Blinding is used to reduce the potential for bias.
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Blinding
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Preventing identification of treatments/procedures/test to trial subjects or study personnel results in order to limit bias.
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CA
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Competent Authority
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CAPRA
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Canadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR: Association canadienne des professionnels en réglementation)
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Carcinogen
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Cancer-causing agent
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Carry-over effect
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Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication’s known biological activity.
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Case Report form (CRF)
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A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject.
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Categorical data
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Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.
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Causality assessment
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An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event.
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CBER
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Centre for Biologics Evaluation and Research (FDA US)
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CCRA
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Certified Clinical Research Associate (certification issued to clinical coordinators by ACRP)
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CCRC
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Certified Clinical Research Coordinator (certification issued to clinical coordinators by ACRP)
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CCRP
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Certified Clinical Research Professional (SoCRA certification of coordinators, monitors, and other research professionals)
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CDE
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Centre for Drug Evaluation, Taiwan
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CDER
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Centre for Drug Evaluation and Research (FDA US)
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CDISC
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Clinical Data Interchange Standards Consortium
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CDRH
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Centre for Devices and Radiological Health (FDA US)
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| Cell Culture |
A method for growing cells isoloated from living organisms under laboratory conditions. |
| Cell Therapy |
A form of therapy in which cells are grown or manipulated in culture and then administered to a patient to treat a disease. |
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CFR
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Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211) (FDA US)
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CGMP
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Current Good Manufacturing Practices
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| CGTP |
Current Good Tissue Practices |
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CIOMS
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Council for International Organisations of Medical Sciences
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Clean database
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A set of reviewed data in which errors have been resolved to meet quality assurance requirements for error rate and in which measurements and other values are provided in acceptable units.
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Clinical data
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Data pertaining to the medical well-being or status of a patient or subject.
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Clinical Development Plan
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A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization.
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Clinical efficacy
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Power or capacity to produce a desired effect (ie. appropriate pharmacological activity in a specified indication/disorder) in humans.
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Clinical investigation
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A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks. Clinical investigations can only be conducted with the approval of the TGA.
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Clinical research
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Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g. health services research).
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Clinical pharmacology
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Science that deals with the characteristics, effects, properties, reactions and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME).
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Clinical Research Associate (CRA)
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Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs.
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Clinical Research Coordinator (CRC)
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Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit.
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Clinical significance
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Change in a subject’s clinical condition regarded as important whether or not due to the test intervention/treatment.
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Clinical Study (trial) Report
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A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report.
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Clinical trial
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Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s), and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.
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Clinical Trial Exemption (CTX)
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A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Therapeutic Goods Administration (TGA Australia) which approves or rejects the application (generally within 50 working days).
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Clinical trial materials
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Complete set of supplies provided to an investigator by the trial sponsor.
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Clinical Trial Notification (CTN)
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A scheme that allows notification to the TGA (Australia) of the intention to start a trial once ethical-scientific approval is obtained.
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CMC
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Chemistry, Manufacturing and Control
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Codelist
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Finite list of codes and their meanings that represent the only allowed values for a data item.
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Coding
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In clinical trials, the process of assigning data to categories for analysis (adverse events, for example, may be coded using MedDRA).
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Cohort study
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Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective.
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Common Technical Document (CTD)
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A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use.
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Comparative Study
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One in which the investigative drug is compared against another product, either active drug or placebo.
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Comparator (product)
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An investigational or marketed product (ie. active control), or placebo, used as a reference in a clinical trial.
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Compassionate Use
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A method of providing experimental therapeutics prior to Regulatory approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the Regulator for “compassionate use” of a drug or therapy.
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Competent Authority (CA)
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The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
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Compliance (in relation to trials)
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Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.
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Confidence interval
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A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the “true” value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision.
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Confirmatory trial
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Phase 3 trial during which the previously revealed actions of a therapeutic intervention are confirmed.
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Consent form
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Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involves.
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| Contract Manufacturing Organisation (CMO) |
A company that offers manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trials purposes and commercialisation. |
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Contract Research Organisation (CRO)
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A person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
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Control group
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The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo.
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Control(s)
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Comparator against which the study treatment is evaluated [eg. concurrent (placebo, no treatment, dose-response, active) and external (historical, published literature)]
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Controlled study
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A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, active treatment, placebo, or dose comparison concurrent control.
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Coordinating committee
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A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
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Correlation
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The degree to which two or more variables are related.
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COSA
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Clinical Oncological Society of Australia
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COSTART
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Coding Symbols for a Thesaurus of Adverse
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Covariate (prognostic)
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Factor or condition that influences outcome of a trial.
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CRA
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Clinical Research Associate
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CRC
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Clinical Research Coordinator
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CRF
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Case Report form
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CRO
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Contract Research Organization
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Crossover trial
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A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a wash-out period between the two products.
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CSM
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Committee on Safety of Medicines (UK)
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CSR
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Clinical Study Report
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CT
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Clinical Trial
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CTA
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Clinical Trial Agreement
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CTD
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Common Technical Document
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CTM
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Clinical Trials Materials
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CTN
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Clinical Trial Notification
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CTX
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Clinical Trial Exemption
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Data clarification
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Answer supplied by the investigator in response to a query.
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Data clarification form
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A form used to query an investigator and collect feedback to resolve questions regarding data.
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Data management
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Tasks associated with the entry, transfer and/or preparation of source data and derived items for entry in a clinical trial database.
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Data monitoring
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Process by which clinical data are examined for completeness, consistency and accuracy.
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Data quality
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Describes the characteristics that confirm “fitness for use” – that is, ability to support meaningful and trustworthy conclusions and interpretations. Quality is established through formal assessment, quality control and auditing.
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Data transformations
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Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis.
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Dataset
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An organized collection of data or information with a common theme arranged in rows and columns represented as a single file; comparable to a database table.
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DD
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Department of Drugs (Swedish Regulatory Agency)
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Declaration of Helsinki
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A set of recommendations or basis principles that guide medical doctors in the conduct of biomedical research involving human subjects.
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Demographic data
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Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.
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Derived variable
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New variable created as a function of existing variables and/or application of mathematical functions.
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Development plan
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An ordered program of clinical trials, each with specific objectives.
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DIA
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Drug Information Association
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Diagnostic
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A product used for the diagnosis of disease or medical condition.
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Discontinuation
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The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject.
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Discrepancy
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The failure of a data point to pass a validation check.
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DLT
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Dose-limiting toxicity
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DNA chip
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A small piece of glass or silicon that has small pieces of DNA arrayed on its surface.
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Dosage
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The amount of drug administered to a patient or test subject over the course of the clinical study; a regulated administration of individual doses.
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Dosage regimen
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The number of doses per given time period; the elapsed time between doses (for example, every six hours) or the time that the doses are to be given (for example, at 8 am and 4 pm daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing.
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Dose
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The amount of drug administered to a patient or test subject at one time or the total quantity administered.
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Dose-ranging Study
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A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.
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Double-blind study
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A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving.
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Double-dummy
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A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical.
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Dropout
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A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol.
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Drug
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Article other than food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body.
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Drug delivery
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The process by which a formulated drug is administered to the patient.
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Drug development process
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The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.
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Drug-Drug interaction
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A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.
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EC
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European Commission
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eCRF
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Electronic case report form
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eCTD
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Electronic Common Technical Document
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Edit check
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An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range or other properties that is intended to reduce error.
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Effective dose
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The dose of an investigational agent that produces the outcome considered "effective", as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.
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Efficacy
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The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed.
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EFGCP
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European Forum for Good Clinical Practice
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EFPIA
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European Federation of Pharmaceutical Industries and Associations
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Electronic data capture (EDC)
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The process of collecting clinical trial data into a permanent electronic form.
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EMEA
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European Agency for the Evaluation of Medicinal Products
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Endpoint
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Variable that pertains to the efficacy or safety evaluations of a trial.
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Enroll
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To register or enter into a clinical trial; transitive and intransitive.
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EORTC
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European Organisation for Research and Treatment of Cancer
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ePRO
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Patient Research Outcome data initially captured electronically.
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Equivalence trial
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A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant.
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ERSR
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Electronic regulatory submissions and review (FDA’s e-Submissions processing group)
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Essential documents
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Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
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Ethics Committee
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An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
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EU
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European Union
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EUDRACT
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European Union clinical trials database
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Evaluable (for efficacy and safety)
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Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in Efficacy/Safety datasets.
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EWG
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Expert Working Group (EU)
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Exclusion criteria
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List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.
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Exploratory trial
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Phase 1 or 2 trial during which the actions of a therapeutic intervention are assessed and measured.
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Fast Track
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Programs that are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
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| FDA |
Food and Drug Administration (US) |
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First subject (patient) in (FSI, FPI)
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The date and time the first subject is enrolled and randomized into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form.
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First subject screened
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First subject who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
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First-in-humans study (first-in-man study)
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The first Phase 1 study in which the test product is administered to human beings.
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FPI
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First patient in
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FSI
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First subject in
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GCP
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Good Clinical Practice
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| Gene |
A natural unit of hereditary material that is the physical basis for the transmission of the characteristics of living organisms from one generation to another. The basic genetic materal is fundamentally the same in all living organisms. It consists of DNA in most organisms and RNA in certain viruses. |
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Gene therapy
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The replacement of a defective gene in an organism suffering from a genetic disease. Recombinant DNA techniques are used to isolate the functioning gene and insert it into cells.
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Generic drug
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A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug. A generic drug may only be marketed after the original drug's patent has expired.
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Generic name
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The drug identifying name to which all branded (proprietary) names for that indication are associated.
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| Genome |
All of the DNA in an organism, which includes genes and DNA that does not carry genetic code (known as introns and exons). Each animal or plant has its own unique genome. Genetic DNA is the molecular code that carries information for making all the proteins required by a living organism. |
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Genomics
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The study of genes and their function
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| Genotype |
Genetic makeup of an individual or group. |
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Glossary
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A collection of specialized words or terms with their meanings.
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| GMP Facility |
A production facility or clinical trial materials pilot plant for manufacturing drug products or APIs. Includes manufacturing space, storage warehouses for raw and finished product, support lab areas, as well as laboratories that are independent of production facilities. |
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Good Clinical Practice (GCP)
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A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
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| Good Laboratory Practice (GLP) |
A set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. |
| Good Manufacturing Practice (GMP) |
A set of principles and procedures which, when followed by manufacturers of drugs and other therapeutics, helps ensure that the products manufactured will be of the required quality. |
| Good Tissue Practices (GTP) |
Regulations that govern methods used in, and facilities used for manufacturing human cellular and tissue-based products. Current Good Tissue Practice (CGTP) requirements are less extensive in scope than CGMP and are limited to preventing circumstances concering the introduction, transmission and spread of communicable disease. CGTPs are intended to assure that products do not get contaminated during manufacturing. |
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GPMS
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Good Postmarketing Surveillance Practice (Japan)
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Group sequential design
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A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests.
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GTRAP
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Gene and Related Therapies Research Advisory Panel (Australia)
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GxP
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Good [pharmaceutical] practice
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Healthy volunteer
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Subject (not a patient) in a clinical trial.
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| High-Throughput Screening (HTS) |
A process in which batches of compounds are tested for binding activity or biological activity against target molecules. HTS seeks to evaluate large numbers of compounds rapidly and in parallel. |
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HIPAA
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Health Insurance Portability and Accountability Act
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HL7
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Health Level 7 (a not-for-profit ANSI-accredited standards developing/development organization (SD))
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HREC
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Human Research and Ethics Committee (Australia)
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Human Research Ethics Committee (HREC)
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An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the HREC's responsibility to ensure that the study adheres to the TGA's regulations.
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Human subject
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Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
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Hypothesis to test
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In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value.
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IB
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Investigator’s brochure
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IBC
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Institutional Biosafety Committee
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IC
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Informed Consent
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ICD9
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International Classification of Diseases, 9th revision. (See also MedDRA)
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ICF
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Informed Consent Form
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ICH
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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IDMC
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Independent Data Monitoring Committee
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IEC
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Independent Ethics Committee
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IFAPP
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International Federation of Associations of Pharmaceutical Physicians
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IFPMA
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International Federation of Pharmaceutical Manufacturers and Associations
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Inclusion criteria
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The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study.
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IND
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Investigational New Drug application (FDA).
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Independent Data Monitoring Committee (IDMC)
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A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify or terminate the trial.
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Independent Ethics Committee (IEC)
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An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
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Indication
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A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials.
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| Individualised Medicine |
The goal of an individual care plan based upon knowledge of a person's genetic profile primarily drived from gene expression analyses and genotyping, and including both disease susceptibility analyses and response-to-treatment/medication profiling. |
| Informatics |
The study of the application of computer and statistical techniques to the management of information. In genome projects, informatics includes the development of methods to search databases quickly, to analyse DNA sequence information, and to predict protein sequence and structure from DNA sequence data. |
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Informed consent
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An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive process, rather than a one-time information session.
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INN
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International Nonproprietary Name
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Institutional Review Board (IRB)
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An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (US)
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Intention to treat
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The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (ie. the planned treatment regimen) rather than the actual treatment given. This has the consequence that subjects allocated to a treatment group should be followed up, assessed, and analyzed as members of that group irrespective of their compliance with the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment.
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Interaction (qualitative and quantitative)
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The situation in which a treatment contract (eg. difference between investigational product and control) is dependent on another factor (for example, the centre). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor; for a qualitative interaction, the direction of the contrast differs for at least one level of the factor.
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Interim analysis(es)
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Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete.
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Investigational New Drug (IND)
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A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes. (FDA, US)
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Investigational treatment
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An intervention under investigation in a clinical trial.
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Investigator
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1. A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
2. The individual “under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team”.
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Investigator’s Brochure (IB)
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A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
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| In Silico Testing |
Test perfomed in a computer model. |
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In Vitro Testing
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Non-clinical testing conducted in an artificial environment such as a test tube or culture medium. Literally in glass.
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In Vivo Testing
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Testing conducted in living animal and human systems.
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IRB
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Institutional Review Board; Independent Review Board (US)
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KFDA
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Korean Food and Drug Administration
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Korean Food and Drug Administration (KFDA)
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The South Korean agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
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Label
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Description of a drug product/device that includes: the indication, who should use it, adverse events, instructions for use, and safety information.
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Last subject (patient) out/complete (LSC/LPC or LSO/LPO)
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1. The date and time when the last subject has reached a planned or achieved milestone representing the completion of the trial.
2. The last subject to complete a trial
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| Lead Compound |
A peptide or small molecule that can bind to a target and bring about a therapeutic effect. A successful lead compound will become a drug candidate for clinical trials. |
| Lead Optimization |
The process of creating the most advantageous lead compound in terms of its binding affinity for the discovery and production of drugs. |
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Longitudinal study
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Investigation in which data is collected from a number of subjects over a long period of time.
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LPC
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Last Patient Complete
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LPO
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Last Patient Out
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LSC
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Last Subject Complete
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LSO
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Last Subject Out
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MA
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Marketing Authorization
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MAA
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Marketing Authorization Application (EU)
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MABEL
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Minimum Anticipated Biological Effect Level
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MAH
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Marketing Authorization Holder (EU)
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Marketing Support Trials
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Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another.
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Masking
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See blinding
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Mean
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The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.
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MedDRA
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Medical Dictionary for Regulatory Activities (global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others)
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Median
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The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.)
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Medical monitor
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A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.
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Medicines and Healthcare products Regulatory Agency (MHRA)
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The UK Government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
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Medsafe
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New Zealand Medicines and Medical Devices Safety Authority
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Meta-analysis
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The formal evaluation of the quantitative evidence from two or more trials bearing on the same question.
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Metadata
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Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.
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MHRA
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Medicines and Healthcare products Regulatory Agency
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Mode
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The most frequently occurring value in a data set.
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Monitor
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Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance.
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Monitoring
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The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
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Monitoring Report
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A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
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MOU
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Memorandum of Understanding
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MRA
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Medical Research Associate
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MREC
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Multicentre Research Ethics Committee (UK)
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MTD
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Maximum Tolerated Dose
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Multicentre trial
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Clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
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MVP
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Master Validation Plan
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NAI
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No Action indicated (most favourable FDA post-inspection classification)
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NCE
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New Chemical Entity
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NCR
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No Carbon [paper] Required
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NDA
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New Drug Application (FDA US)
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NDS
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New Drug Submission (Canada’s new drug application or marketing authorisation application)
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New Drug Application (NDA)
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An application to FDA for a license to market a new drug in the United States.
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NHMRC
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National Health and Medical Research Council (Australia)
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NIH
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National Institutes of Health (US)
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NME
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New Molecular Entity
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NOAEL
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No-observed-adverse-effect level
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NOEL
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No observable effect level (dose of an experimental drug given preclinically that does not produce an observable toxicity)
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Null hypothesis
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The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained.
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Nuremberg Code
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Code of ethics, set forth in 1947, for conducting human medical research.
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| Nutraceutical |
A medicinally or nutritionally functional food |
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ODBT
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Office of Devices, Blood and Tissues (FDA, US)
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Off-Label use
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A drug prescribed for conditions other than those approved by the Regulator.
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OGTR
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Office of the Gene Technology Regulator (Australia)
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Open-label study
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A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study.
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Original data
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Those values that represent the first recording of study data.
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Orphan drugs
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An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a manufacturer specific financial incentives to develop and provide such medications.
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OTC
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Over-the-counter (refers to nonprescription drugs)
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Outcomes research
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Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions.
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Outliers
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Values outside of an expected range.
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Packaging
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The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
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Pairing
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A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B
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Parallel trial
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Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial.
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Parameter
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A variable in a model, or a variable that wholly or partially characterizes a probability distribution (mathematics and statistics). In clinical trials the term is often used synonymously with “variable” for factual information (age, date of recovery), measurements and clinical assessments.
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Participant
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A person or entity with a role in healthcare or a clinical study.
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Patient
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Person under a physician’s care for a particular disease or condition.
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Patient file
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One that contains demographic, medical and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paper records
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Patient-reported outcome (PRO)
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Report coming directly from patients or subjects through interviews or self-completed questionnaires or other data capture tools such as diaries about their life, health condition(s) and treatment.
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Period effect
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An effect occurring during a period of a trial in which subjects are observed and no treatment is administered.
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Per-protocol analysis set
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The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
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Pharmacodynamics
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Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.
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Pharmacoeconomics
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Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments.
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Pharmacogenetics
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Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.
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Pharmacogenomics
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Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favourably, adversely, or not at all to an investigational product.
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Pharmacokinetics
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Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products.
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Pharmacology
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Science that deals with the characteristics, effects and uses of drugs and their interactions with living organisms.
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Pharmacovigilance
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Term used for adverse event monitoring and reporting.
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| Phase 0 |
An exploratory clinical study to gain a better understanding of drug parameters. |
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Phase 1
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The initial introduction of an investigational new drug into humans. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
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Phase 2
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Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
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Phase 3
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Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting the effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
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Phase 4
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Postmarketing (Phase 4) studies to delineate additional information about the drug’s risks, benefits and optimal use that may be requested by regulatory authorities in conjunction with marketing approval.
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Phenotype
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Observable characteristics resulting from interaction between an organism’s genetic makeup and the environment.
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PhRMA
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Pharmaceutical Research and Manufacturers of America
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PI
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Principal Investigator
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PK
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Pharmacokinetics
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Placebo
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A mock treatment or drug that has no effect on the illness, given in a clinical trial to the control group to help differentiate the specifc versus nonspecific effects of an experimental treatment.
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Placebo effect
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A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.
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PMA
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Pre-Market Approval Application (FDA US)
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PMDA
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Pharmaceutical and Medical Devices Agency (Japan)
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PMS
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Postmarketing surveillance
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Population
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Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled.
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Postmarketing surveillance
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Ongoing safety monitoring of marketed drugs.
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Preclinical studies
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Animal and other nonhuman studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP).
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Preclinical studies
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Studies that test a drug on animals and in other nonhuman test systems.
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Pre-Market Approval Application (PMA)
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An application to FDA for a licence to market a new device in the United States.
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Primary variable
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An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation.
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PRO
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Patient-reported outcome
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Proprietary name, trade name, brand name
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A commercial name granted by a naming authority for use in marketing a drug/device product.
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Prospective study
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Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol.
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| Proteomics |
The study of gene expression at the protein level, by the identifying and characterising proteins present in a biological sample. Comparing samples from healthy and diseased tissues allows the identification of proteins that are specific to diseased cells. May be potential diagnostic markers for particular diseases, or targets for drug development. |
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Protocol
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A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
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Protocol amendment(s)
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A written description of a change(s) to or formal clarification of a protocol.
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Protocol deviation
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A variation from processes or procedures defined in a protocol.
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Protocol violation
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A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per-protocol analysis, and may require that the subject(s) who violate the protocol be discontinued from the study.
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PSUR
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Periodic Safety Update Report
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P-value
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Study findings can be assessed in terms of their statistical significance. The P value represents the probability that the observed data (or a more extreme result) could have arisen by chance when the interventions did not differ.
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QA
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Quality Assurance
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QC
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Quality Control
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QOL
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Quality of Life (also QoL)
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QPNIF
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Queensland Pharmaceuticals and Nutraceuticals Industry Forum
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Quality Assurance (QA)
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All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s).
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| Quality by Design (QbD) |
A two-fold program to: (1) develop a pharmaceutical, biologic or medical device to meet predefined product quality, safety and efficacy specifications; and
(2) design the manufacturing processes and controls around that pharmaceutical, biologic or medical device to meet predefined product quality, safety and efficacy specifications.
QbD begins in the preclinical, research and development phase, and carries forward through post-market and into retirement of the product.
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Quality control (QC)
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The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.
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Quality of life
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A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationships to salient features of the environment.
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Query
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A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
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Query management
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Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data.
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Query resolution
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The closure of a query usually based on information contained in a data clarification.
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Questionnaire
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A set of questions or items shown to a respondent in order to get answers for research purposes.
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R&D
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Research and Development
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Random allocation
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Assignment of subjects to treatment (or control) groups in an unpredictable way.
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Randomization
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The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
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Raw data
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Data as originally collected. Distinct from derived data. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations.
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RCT
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Randomised Clinical Trial
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RDE
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Remote Data Entry
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Recruitment (subjects)
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Process used by investigators to find and enroll appropriate subjects (those selected on the basis of the protocol’s inclusion and exclusion criteria) into a clinical study.
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Recruitment period
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Time period during which subjects are or are planned to be enrolled in a clinical trial.
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Registry
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A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
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Research Team
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Investigator, sub-investigators and clinical research coordinators involved with study.
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Result synopsis
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The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information.
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Retrospective
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Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time.
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RFP
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Request for Proposal
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RL
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Regulatory Letter (FDA – post-audit letter)
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SAE
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Serious Adverse Event
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Safety and tolerability
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The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety tests (eg. ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject.
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Sample size
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1. A subset of a larger population, selected for investigation to draw conclusions or make estimates about the larger population.
2. The number of subjects in a clinical trial.
3. Number of subjects required for primary analysis.
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SAS
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Statistical Analysis System (commonly used statistical analysis package)
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Screen failure
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Potential subject who did not meet one or more criteria required for participation in a trial.
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Screening (or subjects)
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A process of active consideration of potential subjects for enrolment in a trial.
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SDV
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Source Document (data) Verification
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Serious adverse event (SAE) or serious adverse drug reaction (serious ADR)
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Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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SFDA
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State Food and Drug Administration, China
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Single-blind study
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A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called single-masked study.
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SLA
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Service Level Agreement
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SMO
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Site Management Organization
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SmPC
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Summary of Product Characteristics
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SNOMED
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Systematized Nomenclature of Medicine (a dictionary)
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SoCRA
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Society of Clinical Research Associates
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Somatic cell gene therapy
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Somatic cell gene therapy involves the insertion of genes into cells for therapeutic purposes.
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SOP
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Standard Operating Procedure
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Source data
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All information in original records and certified copies of original records of clinical finding, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
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Source data verification
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The process of ensuring that data that have been derived from source data accurately represent the source data.
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Source document verification
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The process by which the information reported by an investigator is compared with the original records to ensure that it is complete, accurate and valid.
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Source documents
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Original documents, data, and records (eg. hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records etc.)
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Sponsor
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1. An individual, company, institution or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
2. A corporation or agency who employees conduct the investigation is considered a sponsor and the employees are considered investigators.
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Sponsor-investigator
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An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to or used by a subject.
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Standard deviation
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Indicator of the relative variability of a variable around its mean; the square root of the variance.
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Standard of care
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A guideline for medical management and treatment.
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Standard operating procedures (SOPs)
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Detailed, written instructions to achieve uniformity of the performance of a specific function.
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Statistical analysis plan
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A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.
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Statistical significance
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State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say “significant at the 5% level”. This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.
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Stochastic
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Involving a random variable; involving chance or probability.
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Stopping rules
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A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.
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Stratification
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Grouping defined by important prognostic factors measured at baseline.
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Study design
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Plan for the precise procedure to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments, blinding methods.
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Study initiation
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Date and time of informed consent of first subject enrolled in a study.
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Study population
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Defined by protocol inclusion/exclusion criteria.
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SUAE
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Serious unexpected adverse event
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Subject/trial subject
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An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control.
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Surrogate marker
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A measurement of a drug’s biological activity that substitutes for a clinical endpoint such as death or pain relief.
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Surrogate variable
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A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical.
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TGA
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Therapeutic Goods Administration (Australia)
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Toxicity
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An adverse effect produced by a drug that is detrimental to the participant’s health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.
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Trial site
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The location(s) where trial-related activities are actually conducted.
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Trial statistician
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A statistician who has a combination of education/training and experience sufficient to implement the principles in the ICH E9 guidance and who is responsible for the statistical aspects of the trial.
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Type 1 (or type I) error
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Error made when a null hypothesis is rejected but is actually true.
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Type 2 (or type II) error
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Error made when an alternative hypothesis is rejected when it is actually true.
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Unblinding
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Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators.
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VAI
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Voluntary Action Indicated (FDA postaudit inspection classification)
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Variance
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A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n-1 for a sample variance.
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Verification
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The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
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Volunteer
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A person volunteering to participate as a subject in a clinical trial, often a healthy person agreeing to participate in a Phase 1 trial.
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Warning letter
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A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice.
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Wash-out period
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A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated).
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Weighting
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An adjustment in a value based on scientific observations within the data.
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WHOART
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World Health Organization Adverse Reaction Terminology
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XML
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Extensible Mark-up Language
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