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outcomes research
|
<b>CDISC Definition:</b> Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions. NOTE: Usually distinguished from research conducted solely to determine efficacy and safety. [Guyatt et al., 1993] See also pharmacoeconomics, quality of life.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
outliers
|
<b>CDISC Definition:</b> Values outside of an expected range.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
overdose
|
<b>CDISC Definition:</b> Administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. [After, EU Guideline on good pharmacovigilance practices (GVP)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
p-value
|
<b>CDISC Definition:</b> The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
packaging
|
<b>CDISC Definition:</b> 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
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pairing
|
<b>CDISC Definition:</b> 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. See also matched-pair design.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
palliative therapy
|
<b>CDISC Definition:</b> Therapy administered to relieve the symptoms and reduce the suffering caused by advanced, progressive disease. [After NCI Thesaurus] See also treatment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pandemic
|
<b>CDISC Definition:</b> An epidemic occurring worldwide, or over a very wide area, crossing international boundaries, and usually affecting a large number of people. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
parallel trial
|
<b>CDISC Definition:</b> A trial design in which subjects are randomised to one of two or more arms, with each arm being allocated a different intervention for the duration of the study. NOTE: These interventions will include the investigational product at one or more doses and one or more controls, such as placebo, an active comparator, or both. [After ICH E9; after NIH National Center for Advancing Translational Sciences, Toolkit for Patients-Focused Therapy Development, Glossary] See also randomized controlled trial (RCT), crossover trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
parameter
|
<b>CDISC Definition:</b> A variable in a model, or a variable that wholly or partially characterizes a probability distribution (mathematics and statistics). NOTE: in clinical trials the term is often used synonymously with 'variable' for factual information (age, date of recovery), measurements, and clinical assessments. it is most appropriately linked to statistical conventions and as a numeric characteristic of a population. Parameters are rarely known and are usually estimated by statistical computation from samples. Thus the term is narrower than variable. [Parexel Barnett; ADaM; HyperStat Online] See also variable, outcome.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
participant
|
<b>CDISC Definition:</b> A person or entity with a role in a clinical study. NOTE: Participants can be human subjects or study personnel. The term "participant" is used with growing frequency in some clinical and patient-facing documents like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, study participant.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
password aging
|
<b>CDISC Definition:</b> A practice applying to multi-user computer systems where the validity of a password expires after a certain pre-set period. NOTE: FDA requires that passwords that are part of electronic signatures be "periodically checked, recalled or revised," but does not mandate password aging. [After NIST, 21 CFR 11]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
patient file
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
patient
|
<b>CDISC Definition:</b> Person under a physician's care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. Although often used interchangeably as a synonym for subject, a healthy volunteer is not a patient. See also human subject, clinical research subject, healthy volunteer, participant.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
patient-reported outcome (PRO)
|
<b>CDISC Definition:</b> A type of clinical outcome assessment. A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else. NOTE: A PRO can be measured by self-report or by interview provided that the interviewer records only the patient's response. Symptoms or other unobservable concepts known only to the patient can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. [After BEST Resource]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
peer review
|
<b>CDISC Definition:</b> Primarily, the critical assessment by experts (who are usually not part of the editorial staff) of manuscripts submitted to journals. NOTE: Because unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including scientific research, peer review is an important extension of the scientific process. [After ICMJE Recommendations]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
per-protocol analysis set
|
<b>CDISC Definition:</b> 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. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
performance outcome (PerfO)
|
<b>CDISC Definition:</b> A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. After BEST Resource]
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
performed activity
|
<b>CDISC Definition:</b> Clinical trial events as they actually occurred (as compared with events planned in the protocol).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
period effect
|
<b>CDISC Definition:</b> An effect occurring during a period of a trial in which subjects are observed and no treatment is administered.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
permanent data
|
<b>CDISC Definition:</b> Data that become or are intended to become part of an electronic record in relation to a regulatory submission. NOTE: Any changes made to such permanent data are recorded via an audit trail so that prior values are not obscured.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
permissible values
|
<b>CDISC Definition:</b> Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
personal data retention
|
<b>CDISC Definition:</b> The act of maintaining or holding personal data and those obligations on the part of controllers to retain personal data for certain specified purposes. [After European Data Protection Supervisor, Glossary, https://www.edps.europa.eu/data-protection/data-protection/glossary/d_en, Accessed 2025-02-27] See also personal data, processing (personal data), data controller.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
personally identifiable information (PII)
|
<b>CDISC Definition:</b> Any information about an individual maintained by an agency (or group) including but not limited to, education, financial transactions, medical history, and criminal or employment history, which can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, biometric records, etc., including any other personal information that is linked or linkable to an individual. Used in US [NIST Special publication 800-122] See also personal data.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmaceutical product
|
<b>CDISC Definition:</b> Qualitative and quantitative composition of a medicinal product in the dose form authorized by the regulatory authority for administration to patients, and as represented with any corresponding regulated product information. NOTE: A medicinal product may contain one or more pharmaceutical products. In many instances, the pharmaceutical product is the manufactured item. However, there are instances where the manufactured item undergoes further preparation before being administered to the patient (as the pharmaceutical product). [After ISO 11615:2017, 3.1.60]
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacodynamics
|
<b>CDISC Definition:</b> 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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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacoeconomics
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacogenetic test
|
<b>CDISC Definition:</b> An assay intended to study interindividual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacogenetics
|
<b>CDISC Definition:</b> Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacogenomic test
|
<b>CDISC Definition:</b> An assay intended to study interindividual variations in whole genome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. Compare to pharmacogenetic test.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacogenomics
|
<b>CDISC Definition:</b> 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 favorably, adversely, or not at all to an investigational product.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacokinetics
|
<b>CDISC Definition:</b> Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacology
|
<b>CDISC Definition:</b> Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pharmacovigilance
|
<b>CDISC Definition:</b> Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase (within a study)
|
<b>CDISC Definition:</b> A stage in the sequence of activities in a clinical study (e.g., Screening, Randomization, Treatment, Follow-up). See also arm, visit, phase (of clinical development), epoch.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 1
|
<b>CDISC Definition:</b> The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients. NOTE: 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. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also phase.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 2
|
<b>CDISC Definition:</b> Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 2a
|
<b>CDISC Definition:</b> Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] See also phase, phase 2, phase 2b.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 2b
|
<b>CDISC Definition:</b> Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] See also phase, phase 2, phase 2a.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 3
|
<b>CDISC Definition:</b> Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 3b
|
<b>CDISC Definition:</b> Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 4
|
<b>CDISC Definition:</b> Post-approval 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. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase 5
|
<b>CDISC Definition:</b> Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
phase
|
<b>CDISC Definition:</b> A stage in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
placebo
|
<b>CDISC Definition:</b> A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
placebo-controlled study
|
<b>CDISC Definition:</b> A type of study in which a group receiving an experimental treatment is compared with a control group receiving placebo. [After 21 CFR 314.12; After ICH E10] See also placebo.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
plain language writing
|
<b>CDISC Definition:</b> Writing in a way that helps readers understand the content in a document the first time they read it. Note: Plain writing is intended to be clear, concise, well-organized, and follow other best practices appropriate to the topic or field and the intended audience. [After Plain Writing Act of 2010, FDA]. See also health literacy.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
platform trial design
|
<b>CDISC Definition:</b> A type of trial design under a master protocol framework that tests multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
platform trial
|
<b>CDISC Definition:</b> A type of trial conducted under a master protocol and designed to test multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design, platform trial design.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
population
|
<b>CDISC Definition:</b> 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. [AMA style Manual]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
positive test result
|
<b>CDISC Definition:</b> The finding of the test indicates the criteria for the condition tested were met. NOTE: The test condition and the applied criteria are dependent on the specific case, as defined in the test design. The test results must be validated by comparison to a recognized reference standard.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
postmarketing commitment (PMC)
|
<b>CDISC Definition:</b> Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR).
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
postmarketing requirement (PMR)
|
<b>CDISC Definition:</b> FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC).
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
postmarketing surveillance
|
<b>CDISC Definition:</b> Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pragmatic trial
|
<b>CDISC Definition:</b> A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pre-approval access
|
<b>CDISC Definition:</b> A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. NOTE: The intent is treatment, as opposed to research. Individual, Intermediate-size, and Widespread Use Expanded Access, also Emergency IND, are all programs administered under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent of FDA, expands access. [FDA Expanded Access: Information for Physicians]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pre-market approval application (PMA)
|
<b>CDISC Definition:</b> An application to FDA for a license to market a new device in the United States.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
preamble
|
<b>CDISC Definition:</b> A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
preclinical studies
|
<b>CDISC Definition:</b> Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). NOTE: Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
prevalence
|
<b>CDISC Definition:</b> The number of the existing cases of disease or injury in a defined population at a given point in time. NOTE: The relation between incidence and prevalence varies among diseases. There may be low incidence and a high prevalence - as for diabetes - or a high incidence and a low prevalence - as for the common cold. [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to incidence. See also morbidity rate, morbidity, mortality, incidence rate.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
primary completion date
|
<b>CDISC Definition:</b> The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated. NOTE: The primary completion date may or may not be the same as the study completion date. [ClinicalTrials.gov]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
primary objective
|
<b>CDISC Definition:</b> The main scientific question(s) the study is designed to answer. [After ICH E8; ICH E6 6.3] See also objective, secondary objective, exploratory objective.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
primary outcome variable
|
<b>CDISC Definition:</b> 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. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [CONSORT Statement] See also primary objective, outcome, endpoint.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
principal investigator
|
<b>CDISC Definition:</b> The study investigator who has the primary responsibility for the conduct of a study and for the study-related personnel at the participating site(s). NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
privacy breach
|
<b>CDISC Definition:</b> A privacy breach is the loss of, unauthorized access to, or disclosure of, personal information. [Office of the Privacy Commissioner of Canada] See also serious breach.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
probability
|
<b>CDISC Definition:</b> The number of times an event is expected to occur in a study group divided by the number of individuals being studied. [After AMA Manual of Style]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
processing (personal data)
|
<b>CDISC Definition:</b> Any operation or set of operations that are performed on personal data or on sets of personal data, whether or not by automated means. NOTE: Examples are: collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. [After Article 4 GDPR Definitions] See also personal data, data controller, data processor, subprocessor.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
product dose
|
<b>CDISC Definition:</b> The amount of a product administered in a single dose at a point in time. Usually expressed as a weight, volume, or a number of items (e.g., dosage forms) administered. The expression refers to the substance(s) contained in the Product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
progression-free survival
|
<b>CDISC Definition:</b> The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. [NCI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
PROMIS
|
<b>CDISC Definition:</b> NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function, and emotional well-being. [NIH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
prophylaxis
|
<b>CDISC Definition:</b> Practices or interventions used to maintain health and prevent disease or injury. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
proprietary name
|
<b>CDISC Definition:</b> A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL; FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
prospective study
|
<b>CDISC Definition:</b> A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After ClinicalTrials.gov] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protected personal data (PPD)
|
<b>CDISC Definition:</b> Data relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural, or social identity. NOTE: In a clinical trial setting, data refers to collected information. [After EU Directive 95/46/EC] See also processing (personal data), sensitive personal data, data controller, data processor, subprocessor.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol amendment(s)
|
<b>CDISC Definition:</b> A written description of a change(s) to or formal clarification of a protocol. NOTE: If a protocol modification is substantial, it may require notification to the regulatory authority. For example, substantial impacts on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial. [ICH E3; ICH E6 (R2) Glossary 1.45]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol approval (Sponsor)
|
<b>CDISC Definition:</b> Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated. NOTE: Approval by the sponsor usually initiates secondary approvals by IRBs, regulatory authorities, and sites. Protocol amendments usually also require a cycle of approval by sponsor and study staff prior to taking effect.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol deviation
|
<b>CDISC Definition:</b> A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE: Good clinical practice recommends that deviations be summarized by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed. Compare to protocol violation. [See ICH E3]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Protocol Identifying Number
|
<b>CDISC Definition:</b> Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [EudraCT]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol referenced documents
|
<b>CDISC Definition:</b> Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol title
|
<b>CDISC Definition:</b> The name of a study protocol. NOTE: In most cases the protocol title is the same as the study title but in certain cases the titles may be different. See also official protocol title, public protocol title, master protocol.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol violation
|
<b>CDISC Definition:</b> 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. Compare to protocol deviation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
protocol
|
<b>CDISC Definition:</b> 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. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
proxy (as an origin of outcome measures)
|
<b>CDISC Definition:</b> A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO) directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. [CDISC (extension of SDTM based on Table 2 Patrick, D.L., 2003)] See also observer assessment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
proxy respondent
|
<b>CDISC Definition:</b> Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. [Patrick, D.L., 2003; DIA ePRO Workgroup] Compare to observer assessment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
proxy-reported outcome
|
<b>CDISC Definition:</b> A measurement based on a report by someone other than the patient reporting as if he or she is the patient. NOTE: A proxy-reported outcome is not a patient-reported outcome (PRO). FDA does not consider a proxy-reported outcome as a valid endpoint. [After FDA Clinical Outcome Assessment (COA) Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
pseudonymization
|
<b>CDISC Definition:</b> A privacy preservation technique that both replaces the direct association with a data subject and adds an association between a particular set of characteristics relating to the data subject and one or more pseudonyms. Typically, pseudonymization is implemented by replacing direct identifiers (like the subject's name) with a pseudonym such as a randomly generated value. [ISO/TS 25237:2008]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
psychometric reliability
|
<b>CDISC Definition:</b> The degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, and sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected "construct" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability, and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation. See also validation, instrument.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
psychometric validation
|
<b>CDISC Definition:</b> The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, [Guyatt et al., 1993; DIA ePRO Workgroup] See also validation; compare to psychometric reliability.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
psychometrics
|
<b>CDISC Definition:</b> The science of assessing the measurement characteristics of scales that assess human psychological characteristics.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
public protocol title
|
<b>CDISC Definition:</b> The brief descriptive name for the protocol that is intended for the public in easily understood language. NOTE: Public title may also be referred to as a short title or brief title. [Segen's Medical Dictionary] See also official protocol title, protocol title.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
qualitative variable
|
<b>CDISC Definition:</b> One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
quality assurance (QA)
|
<b>CDISC Definition:</b> 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). [ICH E6 R2 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
quality control (QC)
|
<b>CDISC Definition:</b> 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. [ICH E6 R2 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
quality of life (QoL)
|
<b>CDISC Definition:</b> 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. NOTE: Quality of life is one way to measure the benefits or negative impacts of an "improvement" measured in terms of a physiological or psychological symptom. QoL research seeks to quantify what an intervention means to a patient's sense that their life has changed. NOTE: See also definition from FDA eCOA Glossary. [WHO Group, 1994]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
quantitative variable
|
<b>CDISC Definition:</b> One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
query management
|
<b>CDISC Definition:</b> Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
query resolution
|
<b>CDISC Definition:</b> The closure of a query usually based on information contained in a data clarification.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
query
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
questionnaire
|
<b>CDISC Definition:</b> A set of questions or items shown to a respondent in order to get answers for research purposes. [PRO Draft Guidance] See also instrument, survey.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
race
|
<b>CDISC Definition:</b> An arbitrary classification of a taxonomic group that is a division of a species. It usually arises as a consequence of geographical isolation within a species and is characterized by shared heredity, physical attributes and behavior, and in the case of humans, by common history, nationality, or geographic distribution. (NCI)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
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