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specified substance
|
<b>CDISC Definition:</b> Substance defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products. NOTE: This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. [After ISO 11615:2017, 3.1.77]
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[
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sponsor
|
<b>CDISC Definition:</b> An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
sponsor-investigator
|
<b>CDISC Definition:</b> 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. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
standard deviation
|
<b>CDISC Definition:</b> Indicator of the relative variability of a variable around its mean; the square root of the variance.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
standard of care
|
<b>CDISC Definition:</b> A guideline for medical management and treatment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
standard operating procedures (SOPs)
|
<b>CDISC Definition:</b> Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
standard treatment
|
<b>CDISC Definition:</b> A treatment currently in wide use and approved by FDA or other health authority, considered to be effective in the treatment of a specific disease or condition.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
standard
|
<b>CDISC Definition:</b> A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Standards Development Organization (SDO)
|
<b>CDISC Definition:</b> A domestic or international organization that plans, develops, establishes, or coordinates standards by using procedures that incorporate the attributes of openness, balance of interests, due process, an appeals process, and consensus. [After Office of Management and Budget (OMB) Circular A-119]. See also standard, data standards, CDISC standards, and Study Data Standardization Plan.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
statistical analysis plan
|
<b>CDISC Definition:</b> 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. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
statistical distribution
|
<b>CDISC Definition:</b> A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
statistical method
|
<b>CDISC Definition:</b> The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
statistical power
|
<b>CDISC Definition:</b> A measure of the likelihood that a significance test will detect an effect or difference in a sample if the effect or difference exists in the full population. NOTE: The power calculation is a function of factors such as sample size, effect size, and significance level. It is dependent upon the assumption that the differences between the compared treatments are unbiased estimates of the same quantity. [After McHugh ML. Power analysis in research. Biochem Med (Zagreb). 2008;18:263-274; After ICH E9] See also statistical significance, sample size, effect size.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
statistical significance
|
<b>CDISC Definition:</b> The likelihood that an event occurs by chance (e.g., the null hypothesis is rejected). NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that there is a 95% probability that the effect did not occur by chance. [After AMA Manual of Style; After Principles of Epidemiology in Public Health Practice, Third Edition, An Introduction to Applied Epidemiology and Biostatistics, Oct 2006, Updated May 2012, US DHHS]
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[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
stem
|
<b>CDISC Definition:</b> The prompt, question, or instruction in a PRO item. See also response option, item.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
stochastic
|
<b>CDISC Definition:</b> Involving a random variable; involving chance or probability.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
stopping rules
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
stratification
|
<b>CDISC Definition:</b> Grouping defined by important prognostic factors measured at baseline. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
structured data
|
<b>CDISC Definition:</b> Data that have been organized into discrete fields, and may be enumerated, numeric, or codified.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
structured health record information
|
<b>CDISC Definition:</b> Structured health record information is organized into discrete fields, and may be enumerated, numeric, or codified. Examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010].
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[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
structured product label (SPL)
|
<b>CDISC Definition:</b> The structured product labeling (SPL) specification is an HL7 ANSI-approved document markup standard that specifies the structure and semantics for the exchange of product information. [HL7]
|
[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study arm
|
<b>CDISC Definition:</b> A planned pathway through the study to which subjects are assigned, and that describes treatments, exposures, controls, and/or observations. [After BRIDG] See also control, control group.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study compensation
|
<b>CDISC Definition:</b> Money or other forms of payment for participating in a study. NOTE: Compensation can either be offered in monetary forms, i.e., as payment, or non-monetary forms provided as goods or services. [https://health.ec.europa.eu/system/files/2023-06/payment_compensation_template_en.pdf; Payment and Reimbursement to Research Subjects, FDA, 2018] See also study reimbursement.
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[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study completion date
|
<b>CDISC Definition:</b> The date on which the final data for a clinical study were collected because the last study participant made the final visit to the study location (that is, last subject, last visit, or as otherwise defined in the study protocol). NOTE: See also study completion date data element on ClinicalTrials.gov.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study completion
|
<b>CDISC Definition:</b> As defined in the protocol, the point at which all protocol-required activities have been executed. NOTE: According to EU CTR, this should be a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof should be included. [REGULATION (EU) No 536/2014 Article 2.26]
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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 |
Study Data Standardization Plan (SDSP)
|
<b>CDISC Definition:</b> A document that describes the data standardization strategy for clinical and nonclinical studies within a development program. NOTE: A Study Data Standardization Plan is intended to include historical, current, and planned information about the use of study data standards for studies to conform with the current technical formats, and terminologies described in the FDA Data Standards Catalog which applies to CDER, CBER, and CDRH. [After http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf, https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources, https://www.fda.gov/media/102719/download] See also standards, data standards, CDISC standards, and Standards Development Organization.
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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 |
study description
|
<b>CDISC Definition:</b> Representation of key elements of study (e.g., control, blinding, dose, indication, configuration).
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study design rationale
|
<b>CDISC Definition:</b> Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study design schematic
|
<b>CDISC Definition:</b> A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3]
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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 |
study design
|
<b>CDISC Definition:</b> A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. NOTE: Additional elements may include choice of control group(s), method of allocating treatments, blinding methods, and minimization of bias. [After Pocock, Clinical Trials: a Practical approach; After ICH E8; After ICH E9] See also Trial Design Model, arm, epoch, visit, parallel trial, crossover trial.
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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 |
study feasibility
|
<b>CDISC Definition:</b> The likelihood that a study will be completed as designed.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study life cycle
|
<b>CDISC Definition:</b> The flow of events that characterize a research study from start to finish. [NCI]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study monitoring
|
<b>CDISC Definition:</b> The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study participant
|
<b>CDISC Definition:</b> A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones 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, vulnerable subjects, data subject, clinical research subject, participant.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study population
|
<b>CDISC Definition:</b> A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. (CDISC Protocol Entities)
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study publication date
|
<b>CDISC Definition:</b> The date of the publication of scientific articles or abstracts about a clinical study. NOTE: Institute of Medicine (IOM) Report: The committee noted support for open and free access to scientific publications immediately upon publication, as well as the requirement of the U.S. Food and Drug Administration (FDA) to make a summary of clinical trial results available to the public. [ClinicalTrials.gov]
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[
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
study reimbursement
|
<b>CDISC Definition:</b> Money paid to the study subject/participant to offset personal expenses incurred during study participation, as agreed to by the sponsor and participant. See also study compensation.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study report completion date
|
<b>CDISC Definition:</b> The date at which the study report is considered final and will not be subject to any further change prior to submission. NOTE: For interventional studies of adults the study report completion date should be one year from the end of the LPLV, or end of study; for pediatric interventional studies this date should be six months. For non-interventional studies the study report completion date should be one year from the end of the LPLV, end of study, or end of data collection. [EU CTR]
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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 |
study results
|
<b>CDISC Definition:</b> The findings from a research study to include data, statistical analyses, and clinical interpretation. [After ICH E3] See also clinical study report, outcome, result synopsis, outcome of study.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study start date
|
<b>CDISC Definition:</b> The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021]
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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 |
study start
|
<b>CDISC Definition:</b> The criteria for study start, as defined in the protocol, are met.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
study variable
|
<b>CDISC Definition:</b> A term used in trial design to denote a variable to be captured on the CRF. See also variable.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
sub-investigator
|
<b>CDISC Definition:</b> Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject completion
|
<b>CDISC Definition:</b> The case where a subject ceases active participation in a trial because the subject has, or is presumed to have followed all appropriate conditions of a protocol.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject data event
|
<b>CDISC Definition:</b> A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM]
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject identification code
|
<b>CDISC Definition:</b> A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. [ICH]
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject monitoring
|
<b>CDISC Definition:</b> Act of tracking, reporting, and review of a clinical trial subject's status and/ or performance of required activities per protocol. NOTE: Examples include monitoring compliance with treatment and scheduled tasks, tracking measures of symptoms, self reported feelings, and/or behaviors. Subject monitoring supports managing of patient safety and well being by site staff as defined in a protocol. Compare with medical device, medical monitoring.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject trial contact
|
<b>CDISC Definition:</b> Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data. See visit.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subject-reported outcome (SRO)
|
<b>CDISC Definition:</b> An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO).
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
submission model
|
<b>CDISC Definition:</b> A set of data standards (including SDTM, ADaM, and define.xml) for representing data that are submitted to regulatory authorities to support product marketing applications. NOTE: CDISC submission data consist of: tabulations that represent the essential data collected about patients; analysis data structured to support analysis and interpretation; and metadata descriptions.
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
subprocessor
|
<b>CDISC Definition:</b> An authorized third-party to carry out processing activities on a data processor's behalf. [Article 4 GDPR Definitions] See also personal data, processing (personal data), data processor.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
superiority trial
|
<b>CDISC Definition:</b> A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9]
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
supplier (system)
|
<b>CDISC Definition:</b> An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
surrogate endpoint
|
<b>CDISC Definition:</b> An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
surrogate marker
|
<b>CDISC Definition:</b> A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.]
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
surrogate variable
|
<b>CDISC Definition:</b> A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. [ICH E9]
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
survey
|
<b>CDISC Definition:</b> Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data. NOTE: survey refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents. [from ISOQOL comments on PRO Guidance] Compare to instrument.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
suspension (of a clinical trial)
|
<b>CDISC Definition:</b> An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
symptom
|
<b>CDISC Definition:</b> A physical or mental experience or observation reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
synergistic effect
|
<b>CDISC Definition:</b> An interaction between bioactive compounds or drugs that is deemed greater than the sum of each individual component. NOTE: The terms additivity, synergism, and antagonism should be used with care, unless the specific pharmacological pathways or mechanisms of action of the investigated drugs are known. [After Calzetta L, Koziol-White C. Pharmacological interactions: Synergism, or not synergism, that is the question. Curr Res Pharmacol Drug Discov. 2021 Aug 11;2:100046.] See also synergistic effect, antagonistic effect, drug interaction.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
synopsis
|
<b>CDISC Definition:</b> Brief overview prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc. [after ICH E3]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
syntactic
|
<b>CDISC Definition:</b> The order, format, content of clinical trial data and/or documents as distinct from their meaning. NOTE: Syntactic interoperability is achieved when information is correctly exchanged between two systems according to structured rules whether or not sensible meaning is preserved. See also semantic, semantic interoperability.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
synthetic data
|
<b>CDISC Definition:</b> Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
system
|
<b>CDISC Definition:</b> People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
t-test
|
<b>CDISC Definition:</b> A statistical test used to compare the means of two groups of test data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
table of roles and responsibilities
|
<b>CDISC Definition:</b> A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
tabulation dataset
|
<b>CDISC Definition:</b> A dataset structured in a tabular format. NOTE: The CDISC Study Data Tabulation Model (SDTM) defines standards for tabulation datasets that fulfill FDA requirements for submitting clinical trial data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
target enrollment
|
<b>CDISC Definition:</b> The planned number of subjects intended to be enrolled within a study to reach a pre-specified sample size (in any cohort or the entire study). NOTE: Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process. [After clinicaltrials.gov] See also accrual, target population.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
target population
|
<b>CDISC Definition:</b> The group of people in the general population to which the study results can be generalized.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
technology provider
|
<b>CDISC Definition:</b> A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
temporary halt (of a clinical trial)
|
<b>CDISC Definition:</b> An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
term
|
<b>CDISC Definition:</b> One or more words designating something. NOTE: In a controlled vocabulary, terms are considered to refer to an underlying concept having a single meaning. Concepts may be linked to several synonymous terms.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
termination (of a clinical trial)
|
<b>CDISC Definition:</b> Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
terminology
|
<b>CDISC Definition:</b> Set of concepts, designations, and relationships for a specialized subject area. NOTE: In the context of clinical research in human subjects, a standardized, finite set of terms (e.g., CDISC Terminology, MedDRA codes) that denote patient findings, circumstances, events, and interventions. See also glossary, vocabulary. Contrast with nomenclature.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
therapeutic area
|
<b>CDISC Definition:</b> A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
therapeutic effect
|
<b>CDISC Definition:</b> The intended beneficial effect of an intervention on the body or disease. NOTE: Contrast with side effect, which is an unintended effect. [After Zhang P, Wang F, Hu J, Sorrentino R. Exploring the relationship between drug side-effects and therapeutic indications. AMIA Annu Symp Proc. 2013 Nov 16;2013:1568-77.] See also treatment effect, side effect.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
therapeutic index
|
<b>CDISC Definition:</b> The ratio of the dose that produces toxicity (denominator) to the dose that produces a clinically desired or effective response (numerator). NOTE: The therapeutic index is a measure of a drug's safety, because a larger value indicates a wide margin between doses that are effective and doses that are toxic. [After Finkel, R, Clark, M. A., Champe, P. C. & Cubeddu, L. X. (eds) Lippincott's Illustrated Reviews: Pharmacology 4th edn (Lippincott Williams & Wilkins, 2008).]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
token
|
<b>CDISC Definition:</b> Physical key that provides access to a secure electronic system or location.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
traceability (data)
|
<b>CDISC Definition:</b> The ability to track data from source data collection through final use in reporting or analysis to ensure data interoperability, integrity, and interpretability. See also data integrity.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
transcription
|
<b>CDISC Definition:</b> Process of transforming dictated or otherwise documented information from one storage medium to another. NOTE: often refers explicitly to data that is manually transcribed from source docs or measuring devices to CRFs or to eCRFs.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
transition rule
|
<b>CDISC Definition:</b> A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan. See branch.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
translation
|
<b>CDISC Definition:</b> Converting information from one natural language to another while preserving meaning. Compare to mapping.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
translational research
|
<b>CDISC Definition:</b> The multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. NOTE: These studies are designed to translate basic science findings into clinically useful tools and applications and to ensure that new treatments and research knowledge reach the patients or populations for whom they are intended and are implemented correctly. [After Rubio DM, Schoenbaum EE, Lee LS, Schteingart DE, Marantz PR, Anderson KE, Platt LD, Baez A, Esposito K. Defining translational research: implications for training. Acad Med. 2010 Mar;85(3):470-5. and NCI Thesaurus]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
transmit
|
<b>CDISC Definition:</b> To transfer data, usually electronically. NOTE: In eClinical investigations data are commonly transmitted from subjects to clinical study sites, within or among clinical study sites, contract research organizations, data management centers, and sponsors, or to regulatory authorities. [modified from CSUICI].
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
treatment benefit
|
<b>CDISC Definition:</b> The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary] See also benefit summary, clinical benefit.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
treatment contrast interaction
|
<b>CDISC Definition:</b> The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction, the direction of the contrast differs for at least one level of the factor. [ICH E9 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
treatment effect
|
<b>CDISC Definition:</b> Any intended or unintended effect of the intervention on the body or disease. NOTE: In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments. [After ICH E9] See also therapeutic effect, side effect, treatment contrast interaction.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
treatment
|
<b>CDISC Definition:</b> Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis, adjuvant therapy, neoadjuvant therapy, palliative therapy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
treatment-emergent adverse event
|
<b>CDISC Definition:</b> An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
trial design element
|
<b>CDISC Definition:</b> A basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.[CDISC PRM Project] See also epoch.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Trial Design Model
|
<b>CDISC Definition:</b> Defines a standard structure for representing the planned sequence of events and the treatment plan of a trial. NOTE: A component of the SDTM that builds upon elements, arms epochs, visits; suitable also for syntactic interpretation by machines. [CDISC] See study design.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
trial site
|
<b>CDISC Definition:</b> A physical location (e.g., healthcare organization, institution, or facility) directly involved in conducting or facilitating a particular clinical trial. NOTE: There may not be a physical location, see decentralized cluster. [After ICH E6 (R2)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
trial statistician
|
<b>CDISC Definition:</b> 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. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
triple-blind study
|
<b>CDISC Definition:</b> A study in which knowledge of the treatment assignment(s) is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
trustworthy (electronic records)
|
<b>CDISC Definition:</b> An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity. [after 21CFR Part 11]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
type 1 (or type I) error
|
<b>CDISC Definition:</b> Error made when a null hypothesis is rejected but is actually true.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
type 2 (or type II) error
|
<b>CDISC Definition:</b> Error made when an alternative hypothesis is rejected when it is actually true.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
type 3 (or type III) error
|
<b>CDISC Definition:</b> Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
type of comparison
|
<b>CDISC Definition:</b> How treatment arms will be compared (e.g., safety, efficacy, PK/PD). May also include comparison to data from other studies or sources (e.g., historical control). [ICH E9, EudraCT (p.18)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
umbrella trial design
|
<b>CDISC Definition:</b> A type of trial design under a master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
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