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exposure (individual)
|
<b>CDISC Definition:</b> The result of an intentional contact (e.g., intervention, dosage, drug/product use, misuse, or abuse) or an unintentional contact (circumstantial events leading to unknown, inadvertent, or accidental contact) resulting in inputs to the body of an individual which can occur directly through primary bodily contact routes or indirectly through secondary contact routes (such as via fluids as in fetal exposure during pregnancy or lactation/breast feeding or other biological transfers). [After FDA, Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies] See also exposure, intervention, extent of exposure.
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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 |
exposure
|
<b>CDISC Definition:</b> Contact between an agent and a target. A state of contact or close proximity to a medicinal product, chemical, pathogen, radioisotope or other substance. NOTE: Types of exposure may be described by many qualifiers (e.g., local, systemic, acute, chronic, cumulative, environmental, population, individual, gestational, or occupational.) See also exposure (individual), intervention, extent of exposure. [After International Programme on Chemical Safety (IPCS) 2004 WHO]
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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 |
eXtensible markup language (XML) data element
|
<b>CDISC Definition:</b> For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
extent of exposure
|
<b>CDISC Definition:</b> A variable of exposure taking into consideration the strength, dose, duration, frequency, route, and/or timing or gestational stage in utero and other factors. NOTE: Measures of concentrations in biological fluids and tissues may be used to attempt to quantify the extent of exposures (e.g., Cmax, Cmin, Css, AUC in pharmacokinetics or other exposure measurement and assessment models). [After, FDA Guidance for Industry Exposure-Response Relationships] See also exposure, exposure (individual), intervention.
|
[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
extraction transformation load (ETL)
|
<b>CDISC Definition:</b> A class of software applications for data extraction, transformation, and loading that are used to implement data interfaces between disparate database systems, often to populate data warehouses.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
feels
|
<b>CDISC Definition:</b> A patient's physical sensation (e.g., symptoms) or perceived mental state. A patient may feel pain, feel feverish, or perceive a severely low mood (as with depression). [FDA Clinical Outcome Assessment (COA) Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
field
|
<b>CDISC Definition:</b> Locus on a data collection instrument (usually a CRF) for recording or displaying a data element. See data item.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
File Transfer Protocol (FTP)
|
<b>CDISC Definition:</b> A standard protocol for exchanging files between computers on the internet. See also TCP/IP.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
final report
|
<b>CDISC Definition:</b> A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. [ICH E3]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
finding
|
<b>CDISC Definition:</b> A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject in - date, time (FSI - date, time)
|
<b>CDISC Definition:</b> The date and/or date and time the first subject is enrolled into a study. See also enrollment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject in - identity (FSI - identity)
|
<b>CDISC Definition:</b> The first subject enrolled. See also enrollment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject screened - date, time
|
<b>CDISC Definition:</b> The date and/or date and time the first subject signs the informed consent form and is screened for potential enrollment or randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
|
[
"CDISC Glossary.xlsx"
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject screened - identity
|
<b>CDISC Definition:</b> The first subject who is so screened.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject treated - date, time
|
<b>CDISC Definition:</b> The date and/or date and time when the first subject receives the test article or placebo in a clinical investigation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first subject treated - identity
|
<b>CDISC Definition:</b> The first subject who is so treated.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
first-in-humans study
|
<b>CDISC Definition:</b> The first Phase 1 study in which the test product is administered to human beings.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
follow-up (clinical study)
|
<b>CDISC Definition:</b> A period in a clinical study during which selected observations are made, starting after the end of the active part of the study or as specified in the protocol.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Food and Drug Administration (FDA)
|
<b>CDISC Definition:</b> The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Form
|
<b>CDISC Definition:</b> A collection of items and item groups for capturing and displaying clinical trial data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
frequentist methods
|
<b>CDISC Definition:</b> Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. [ICH E9]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
frozen
|
<b>CDISC Definition:</b> Status of a database, file, or element that has been presumed to be in its final state pending "lock" and where further editing is prevented without "unfreezing." NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from "locking" and "unlocking" only in the degree of approval required. See database lock.
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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 |
functional roles (in a study)
|
<b>CDISC Definition:</b> The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
functions
|
<b>CDISC Definition:</b> The manner in which a patient can perform successfully tasks and roles required for everyday living. A patient's ability to perform specified activities that are a meaningful (to the patient), part of typical (e.g., daily) life. [FDA Clinical Outcome Assessment (COA) Glossary]
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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 |
gender
|
<b>CDISC Definition:</b> Subject self-identification re: masculine/feminine. [IOM] See also sex. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
gene therapy
|
<b>CDISC Definition:</b> Ex vivo or in vivo gene modification of cells in order to correct or treat an inherited or acquired disease or condition. NOTE: Gene therapy mechanisms can include: Replacing a disease-causing gene with a healthy copy of the gene; Inactivating a disease-causing gene that is not functioning properly; and Introducing a new or modified gene into the body to help treat a disease. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017; After What is Gene Therapy?, US FDA, 07/25/2018] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product.
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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 |
general observation class
|
<b>CDISC Definition:</b> In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. NOTE: Most CDISC domains are assigned to one of three general observation classes: 1) The Interventions general observation class is a domain that captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (usually for therapeutic purposes) either as specified by the study protocol (e.g., exposure), coincident with the study assessment period (e.g., concomitant medications), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). 2) The Events general observation class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., "adverse events" or "disposition") or prior to the trial (e.g., "medical history"). 3) The Findings general observation class captures the observations resulting from planned evaluations such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, event, intervention, finding. Compare with special purpose domain.
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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 |
generalizability
|
<b>CDISC Definition:</b> The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Generative AI (GenAI)
|
<b>CDISC Definition:</b> Algorithms to organize large, complex data sets into meaningful clusters of information in order to create new content, including text, images and audio, in response to a query or prompt. [George Lawton, "What is GenAI? Generative AI explained", Informa, Mar 13, 2025, https://www.techtarget.com/searchenterpriseai/definition/generative-AI] See also AI prompt, Large Language Model (LLM).
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
generic name
|
<b>CDISC Definition:</b> The name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
global assessment variable
|
<b>CDISC Definition:</b> A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
glossary
|
<b>CDISC Definition:</b> A collection of specialized words or terms with their meanings.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Good Clinical Practice (GCP)
|
<b>CDISC Definition:</b> A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. NOTE: For Guidance on Good Clinical Practice see COMP/ICH/135/95; Declaration of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR 56, and 21 CFR 312. [ICH]
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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 |
granularity
|
<b>CDISC Definition:</b> Refers to the size of an information unit in relation to a whole. NOTE: Structuring "privileges" in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
group sequential design
|
<b>CDISC Definition:</b> A type of adaptive trial design that allows successive, unscheduled interim analyses of the data at particular time points or after a pre-defined number of patients have been enrolled. NOTE: This kind of trial design is chosen to allow for spontaneous interim analyses, in order to, for example, determine whether to stop the trial, adjust the sample size, adjust the dose, or otherwise amend the protocol. [After https://toolbox.eupati.eu/glossary/group-sequential-design/; https://www.statisticshowto.com/group-sequential-design/; https://toolkit.ncats.nih.gov/glossary/group-sequential-trial/] See also interim analysis(es), adaptive design, Bayesian statistics, Bayesian approaches.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
handwritten signature
|
<b>CDISC Definition:</b> The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. NOTE: The act of signing with a writing or marking instrument such as a pen or stylus is preserved. [21CFR 11]
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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 |
harmonized standard
|
<b>CDISC Definition:</b> A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
hazard ratio
|
<b>CDISC Definition:</b> A complex statistical analysis that compares the risk of harm in one group to another. NOTE: Calculated from the Cox Proportional Hazard model. [After AMA Manual of Style; After NCI Thesaurus] See also relative risk.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Health Level 7 (HL7)
|
<b>CDISC Definition:</b> An ANSI-accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization's (ISO) communications model for Open Systems Interconnection (OSI), the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. Level 7 supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations, and, most importantly, data exchange structuring.
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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 |
health literacy
|
<b>CDISC Definition:</b> The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. [After The Patient Protection and Affordable Care Act of 2010, Title V; After What is Health Literacy? Oct 23, 2019]. See also plain language writing.
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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 |
health-related quality of life (HRQoL)
|
<b>CDISC Definition:</b> A multi-domain concept that represents the patient's general perception of the effect of illness and treatment on physical, psychological, and social aspects of life. NOTE: Claiming a statistical and meaningful improvement in HRQoL implies: (1) that all HRQoL domains that are important to interpreting change in how the clinical trial's population feels or functions as a result of the targeted disease and its treatment were measured; (2) that a general improvement was demonstrated; and (3) that no decrement was demonstrated in any domain. [FDA Clinical Outcome Assessment (COA) Glossary] Compare to quality of life (QoL).
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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 |
healthcare facility
|
<b>CDISC Definition:</b> Any public or private entity or agency or medical or dental facility where healthcare services are provided or clinical trials are conducted. [After ICH E6; CIOMS Glossary of ICH terms and definitions]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
healthcare provider
|
<b>CDISC Definition:</b> A person licensed, certified, or otherwise authorized or permitted by law to administer healthcare in the ordinary course of business or practice of a profession, including a healthcare facility. [HL7]
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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 |
healthy volunteer
|
<b>CDISC Definition:</b> A person with no significant health-related issues who agrees to participate as a subject in a clinical study. NOTE: This is often a healthy person in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 2023-03-30]
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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 |
hereditary
|
<b>CDISC Definition:</b> Transmitted from parent to child by genetic transmission. [After NCI]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
HIE (Health Information Exchange)
|
<b>CDISC Definition:</b> The mobilization of healthcare information electronically across organizations within a region or community. HIE provides the capability to electronically move clinical information between disparate healthcare information systems, while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to, and retrieval of, clinical data to provide safer, more timely, efficient, effective, equitable, and patient-centered care. [HITSP]
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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 |
human subject
|
<b>CDISC Definition:</b> Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3]. See also clinical research subject.
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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 |
Huriet Law
|
<b>CDISC Definition:</b> France's regulations covering the initiation and conduct of clinical trials.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
HyperText Markup Language (HTML)
|
<b>CDISC Definition:</b> A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML.
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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 |
hypertext
|
<b>CDISC Definition:</b> Links in a document that permit browsers to jump immediately to another document. NOTE: In most browsers links are displayed as colored, underlined text.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
hypothesis to test
|
<b>CDISC Definition:</b> In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value. [CONSORT Statement]
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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 |
immediately life-threatening disease or condition
|
<b>CDISC Definition:</b> A stage of disease in which there is reasonable likelihood that death will occur within a matter of months, or in which premature death is likely without early treatment. [21 CFR 312.300]
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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 |
immune system
|
<b>CDISC Definition:</b> A complex network of cells, chemicals, tissues, and organs that defends the body from infection and disease. NOTE: Bone marrow, thymus, lymphatic system, lymph nodes, spleen, and mucous membranes can be involved. [After NCI Thesaurus] See also antigen, antibody, autoimmunity.
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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 |
impartial witness
|
<b>CDISC Definition:</b> A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. [ICH]
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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 |
in vitro diagnostic device
|
<b>CDISC Definition:</b> A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis. (After Regulation (EU) 2017/746; After US FDA 21 CFR 809.3)
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[
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
incidence rate
|
<b>CDISC Definition:</b> A proportion calculated as the number of individuals who develop the disease during a period of time divided by the number of persons at risk. [After AMA Style Guide, 10th Edition; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] See also morbidity rate, morbidity, mortality, incidence, prevalence.
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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 |
incidence
|
<b>CDISC Definition:</b> The occurrence of new cases of disease, injury, or disability in a defined population over a specified period of time. NOTE: Incidence is most often expressed relative to the total population at risk (i.e., per unit of population). [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 prevalence. See also morbidity rate, morbidity, mortality, incidence rate.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
inclusion criteria
|
<b>CDISC Definition:</b> The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
independent data monitoring committee (IDMC)
|
<b>CDISC Definition:</b> A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] See also data monitoring committee.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
independent ethics committee (IEC)
|
<b>CDISC Definition:</b> An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
independent variable
|
<b>CDISC Definition:</b> A variable that is not affected by other variables that the study is trying to understand. Independent variables influence dependent variables. [After AMA Manual of Style] See also dependent variable.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
indication
|
<b>CDISC Definition:</b> The target disease or condition, or its manifestations or symptoms, for which the treatment, prevention, mitigation, cure, or diagnosis is studied or approved. NOTE: In the context of product labeling, the disease indication is usually associated with a population of interest. [After 21 CFR 201.57(c)(2); Wording of therapeutic indication. A Guide for Assessors of Centralised Applications. 21 October 2019, EMA/CHMP/483022/2019. Committee for Medicinal Products for Human Use (CHMP)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
indirect identifier
|
<b>CDISC Definition:</b> Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, sex, events, specific findings, etc. NOTE: Two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
informed consent
|
<b>CDISC Definition:</b> A process that provides the subject with explanations that will help in making decisions about whether to begin or continue participating in a study, after having achieved an understanding of the potential risks and benefits. NOTE: Informed consent is an ongoing, interactive process rather than a one-time information session and can use digital methodologies. Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. [US FDA 21 CFR 50.20; After US FDA Use of Electronic Informed Consent Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors, Dec 2016] See also consent form, eConsent form.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
infusion
|
<b>CDISC Definition:</b> Any form of treatment that is introduced into the body slowly by constant administration or drip via a blood vessel, a muscle, or the spinal cord. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also administration (substance).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
ingredient
|
<b>CDISC Definition:</b> Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
inspection
|
<b>CDISC Definition:</b> The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). [ICH] See also audit.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
institutional review board (IRB)
|
<b>CDISC Definition:</b> An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
instrument
|
<b>CDISC Definition:</b> A means to capture data (e.g., questionnaire, diary) plus all the information and documentation that supports its use. NOTE: Generally, instruments include clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis, and interpretation of results. [from PRO Draft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006, by ISOQOL, p. 8).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
intended use
|
<b>CDISC Definition:</b> The specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the "Statement of Intended Use" prepared by the persons legally responsible for the labeling of medical products. [after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
intention-to-treat
|
<b>CDISC Definition:</b> The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given. NOTE: This has the consequence that subjects allocated to a treatment group should be followed up, assessed, and analyzed as members of that group irrespective of their compliance with the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment. [ICH E9; after CONSORT statement]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
inter-rater reliability
|
<b>CDISC Definition:</b> The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
intercurrent event
|
<b>CDISC Definition:</b> An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. [ICH E9 Addendum on Estimands]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
interim analysis schedule
|
<b>CDISC Definition:</b> The time/information points at which interim analyses are planned.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
interim analysis(es)
|
<b>CDISC Definition:</b> Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. [CONSORT statement]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
interim clinical trial/study report
|
<b>CDISC Definition:</b> A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
internal consistency
|
<b>CDISC Definition:</b> Pertaining to data that do not include contradictions.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
international birth date (IBD)
|
<b>CDISC Definition:</b> The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
international nonproprietary name (INN)
|
<b>CDISC Definition:</b> Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
internet service provider (ISP)
|
<b>CDISC Definition:</b> A company that provides access to the internet for individuals and organizations.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
internet
|
<b>CDISC Definition:</b> A global system of computer networks that provides the common TCP IP infrastructure for e-mail, the World Wide Web, and other online activities.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
interoperability
|
<b>CDISC Definition:</b> Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
intervention
|
<b>CDISC Definition:</b> An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Investigational Device Exemption (IDE)
|
<b>CDISC Definition:</b> An application to FDA for a waiver to test a device in a clinical trial. [After US FDA, 21 CFR Part 812]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigational device
|
<b>CDISC Definition:</b> A device that is assessed in a clinical investigation. [REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] See also investigational product, medical device.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigational medicinal product
|
<b>CDISC Definition:</b> A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational medicinal product, experimental intervention.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Investigational New Drug (IND) application
|
<b>CDISC Definition:</b> An application to FDA for a waiver to allow the administration of investigational products in a clinical trial. [After US FDA, 21 CFR Part 312]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigational product code
|
<b>CDISC Definition:</b> A symbol or combination of symbols (usually alphanumeric characters) that are assigned by the sponsor to uniquely identify an experimental intervention. [After ICH M11]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigator
|
<b>CDISC Definition:</b> A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. NOTE: For example, under whose immediate direction the test article is administered or dispensed to, or used involving a subject. [21 CFR 50.3, ICH E6] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigator's brochure
|
<b>CDISC Definition:</b> A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
investigator/institution
|
<b>CDISC Definition:</b> An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements" with respect to the transfer or assignment of responsibilities. [After ICH E6 1.35] See also coordinating investigator, investigator, principal investigator, site investigator, sponsor-investigator, sub-investigator.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
item (PRO)
|
<b>CDISC Definition:</b> An individual question, statement, or task (and its standardized response options) that is evaluated by the patient to address a particular concept. [FDA Clinical Outcome Assessment (COA) Glossary] See also item generation, response option.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
item definition
|
<b>CDISC Definition:</b> Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
item generation
|
<b>CDISC Definition:</b> Establishing the content to be covered by the items in a PRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and readability. NOTE: PRO instrument item generation is potentially incomplete without patient involvement. [from ISOQOL comments on PRO Draft Guidance]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
item group definition
|
<b>CDISC Definition:</b> The specification in an eClinical trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using SDTM which can, for example, distinguish between different therapy types: study therapy, prior therapy, concomitant therapy, protocol forbidden therapies, rescue therapies. [ODM]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
item
|
<b>CDISC Definition:</b> A representation of a clinical variable, fact, concept, or instruction in a manner suitable for communication, interpretation, or processing by humans or by automated means. NOTE: Items are collected together to form item groups. [CDISC] Compare to data item, item (PRO).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Janus conceptual model
|
<b>CDISC Definition:</b> A logical design for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. [FDA Study Data Standards]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Janus study data repository
|
<b>CDISC Definition:</b> The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submission. NOTE: Sometimes written as JANUS, the term is not an acronym. [FDA Study Data Standards]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
label
|
<b>CDISC Definition:</b> Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
labeling (content of)
|
<b>CDISC Definition:</b> All text, tables, and figures in labeling as described in regulations for a specific product (e.g., 21 CFR 201.56 and 201.57 for human prescription drugs; 201.66 for human over-the-counter drugs; 21 CFR 801 for medical devices; and 21 CFR 606.122 for blood products). See also structured product label.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
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