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anticipated adverse event
|
<b>CDISC Definition:</b> Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such "anticipated" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
antigen
|
<b>CDISC Definition:</b> Any substance, generally a protein, that stimulates the immune system and elicits an immune response. Recognition by the immune system elicits either a T-lymphocyte response, recognizing processed antigens, or a B-lymphocyte response, producing antibodies that bind to unprocessed antigens. [NCI] See also antibody, immune system, autoimmunity.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
applet
|
<b>CDISC Definition:</b> A small application, typically downloaded from a server.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
applicable regulatory requirement(s)
|
<b>CDISC Definition:</b> Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
approvable letter
|
<b>CDISC Definition:</b> An official communication from FDA to an NDA/ BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
approval (in relation to Institutional Review Boards)
|
<b>CDISC Definition:</b> The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. [ICH E6]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
approval letter
|
<b>CDISC Definition:</b> An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
artificial intelligence (AI)
|
<b>CDISC Definition:</b> A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. NOTE: Types of artificial intelligence include generative AI and large language models. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017); After FDA Medical Products Paper: Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, March 2024] See also machine learning, deep learning, natural language processing, synthetic data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
assent form
|
<b>CDISC Definition:</b> A document explaining all the relevant information to assist an individual, who is unable to give informed consent on their own behalf, in understanding the expectations and risks in making a decision about a procedure.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
assessment
|
<b>CDISC Definition:</b> The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
attributable
|
<b>CDISC Definition:</b> A quality by which records and data can be traced back to the subject to whom they pertain, as well as to those persons who have acted on the records.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
attribute (n)
|
<b>CDISC Definition:</b> In data modeling, refers to specific items of data that can be collected for a class.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
audit certificate
|
<b>CDISC Definition:</b> Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). [ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
audit report
|
<b>CDISC Definition:</b> A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
audit trail
|
<b>CDISC Definition:</b> A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
audit
|
<b>CDISC Definition:</b> A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
authorised auxiliary medicinal product
|
<b>CDISC Definition:</b> A medicinal product that is currently authorised for marketing in a country or region, that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product, regardless of labelling of the auxiliary medicinal product. [after EU CTR]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
authorised investigational medicinal product
|
<b>CDISC Definition:</b> A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
authorization
|
<b>CDISC Definition:</b> The process of giving someone permission to do or have something. In multi-user computer systems, a system administrator defines for the system which users are allowed access to the system and what privileges of use are permitted. [HL7 EHR-S FM Glossary of Terms, 2010].
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
autoimmunity
|
<b>CDISC Definition:</b> An attack response of the immune system against the body's own components. [Janeway CA Jr, Travers P, Walport M, et al. Immunobiology: The Immune System in Health and Disease. 5th edition. New York: Garland Science; 2001. Autoimmune responses are directed against self antigens. Available from: https://www.ncbi.nlm.nih.gov/books/NBK27155/] See also immune system, antibody, antigen.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
auxiliary medicinal product
|
<b>CDISC Definition:</b> A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. [after EU-CTR]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
back translation (natural language)
|
<b>CDISC Definition:</b> The process of translating a document that was translated from one language to another back to the original language. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
background material
|
<b>CDISC Definition:</b> Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
background treatment
|
<b>CDISC Definition:</b> Medicinal products that are administered to each clinical trial subject, regardless of randomization group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
balanced study
|
<b>CDISC Definition:</b> Trial in which a particular type of subject is equally represented in each study group.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
bandwidth
|
<b>CDISC Definition:</b> An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals. All digital and analog signal channels have a bandwidth.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
baseline assessment
|
<b>CDISC Definition:</b> Assessment of subjects as they enter a trial and before they receive any treatment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
baseline characteristics
|
<b>CDISC Definition:</b> Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NOTE: Randomized, controlled trials aim to compare groups of participants that differ only with respect to the intervention (treatment). although proper random assignment prevents selection bias, it does not guarantee that the groups are equivalent at baseline. any differences in baseline characteristics are, however, the result of chance rather than bias. The study groups should be compared at baseline for important demographic and clinical characteristics. Baseline data may be especially valuable when the outcome measure can also be measured at the start of the trial. [CONSORT statement]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
baseline imbalance
|
<b>CDISC Definition:</b> A systematic error in creating intervention groups, such that they differ with respect to prognosis. That is, the groups differ in measured or unmeasured baseline characteristics because of the way participants were selected or assigned. NOTE: also used to mean that the participants are not representative of the population of all possible participants. [ICH E9]
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
basket trial design
|
<b>CDISC Definition:</b> A type of trial design under a master protocol designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [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 |
basket trial
|
<b>CDISC Definition:</b> A type of trial conducted under a master protocol and designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022; Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.]. See also basket trial design, adaptive design, master protocol.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Bayesian approaches
|
<b>CDISC Definition:</b> Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g., treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. [ICH E9 Glossary]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Bayesian statistics
|
<b>CDISC Definition:</b> Statistical approach named for Thomas Bayes (1701-1761) that has among its features giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
benefit summary
|
<b>CDISC Definition:</b> A description of any physical, psychological, social, or other potential positive effects to individual participants as a result of participating in the study, addressing immediate potential benefits and/or long-range potential benefits. NOTE: In a benefit summary, no or minimal benefits must also be described. [After ICH M11] See also clinical benefit, treatment benefit.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
beta error
|
<b>CDISC Definition:</b> Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis. See also Type 2 error. [AMA Manual of style]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
bias
|
<b>CDISC Definition:</b> Bias refers to defects in study design, measurement, analysis or interpretation such that they cause a result to depart from the true value in a consistent direction. [after AMA Manual of style, ICH E9, CONSORT Statement]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
bioanalytical assays
|
<b>CDISC Definition:</b> Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
bioavailability
|
<b>CDISC Definition:</b> Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biobanking
|
<b>CDISC Definition:</b> The storage of collected biospecimens for future use. (After NHMRC (2010) National Health and Medical Research Council "Biobanks information paper". Canberra. https://www.nhmrc.gov.au/sites/default/files/documents/attachments/Biobanks-information-paper-2010.pdf) See also biospecimen, biorepository.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
bioequivalence
|
<b>CDISC Definition:</b> Scientific basis on which drugs with the same active ingredient(s) are compared. NOTE: To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biological product
|
<b>CDISC Definition:</b> A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition. Such products may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product. NOTE: Biological products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Biological products are generally large, complex molecules and are often more difficult to characterize than small molecule drugs. [After 21 CFR 600.3; After FDA Biological Product Definitions] See also vaccine, cell therapy, gene therapy, pharmaceutical product, drug product, medicinal product.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Biologics licensing application (BLA)
|
<b>CDISC Definition:</b> Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biomarker
|
<b>CDISC Definition:</b> A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; safety biomarker; pharmacodynamic/response biomarker. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biometric signature
|
<b>CDISC Definition:</b> A signature based on the verification of an individual's identity, based on measurement of the individual's physical feature(s) or repeatable action(s), where those features and/or actions are both unique to that individual, and measureable [21 CFR 11]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biorepository
|
<b>CDISC Definition:</b> A storage facility for biospecimens. NOTE: The biorepository has stringent guidelines regarding the standardized collection, handling, storage, and documentation of biological specimens. See also biobanking, biospecimen.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biosimilar
|
<b>CDISC Definition:</b> A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components. This requires that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (see section 351(i)(2) of the PHS Act). [after FDA, Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
biospecimen
|
<b>CDISC Definition:</b> Any material from a biological entity used for testing, diagnostic, propagation, treatment, or research purposes. [See SDTM codelists: https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C78734; https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C111114] See also biobanking, biorepository.
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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 |
biostatistics
|
<b>CDISC Definition:</b> Branch of statistics applied to the analysis of biological phenomena.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
blind review
|
<b>CDISC Definition:</b> Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis. [Modified ICH E9]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
blinded (masked) medications
|
<b>CDISC Definition:</b> Products that appear identical in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators (or anyone assessing the outcome) to determine which medication is being administered.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
blinded study
|
<b>CDISC Definition:</b> A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s). NOTE: Blinding is used to reduce the potential for bias. [Modified ICH E6 Glossary] See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
blinding
|
<b>CDISC Definition:</b> A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. [After Abhaya Indrayan, Martin P. Holt. Concise Encyclopedia of Biostatistics for Medical Professionals. Chapman & Hall; November 17, 2016] See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study, masking.
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[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
blood draw
|
<b>CDISC Definition:</b> The collection of blood from a vein, most commonly via needle venipuncture. (NCI)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
branch
|
<b>CDISC Definition:</b> Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
browser
|
<b>CDISC Definition:</b> Computer program that runs on the user's desktop computer and is used to navigate the World Wide Web. See also web browser.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
cache
|
<b>CDISC Definition:</b> Storage area on a computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
carry-over effect
|
<b>CDISC Definition:</b> Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
case history
|
<b>CDISC Definition:</b> An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation of each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation. NOTE: Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study. [21 CFR 312.62(b)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
case report form (CRF)
|
<b>CDISC Definition:</b> A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items, linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations can be or have been collected by completion of such CRF pages for a subject in a clinical study. See also CRF (paper), eCRF. [ICH E6 Glossary, FDA Final Guidance on eSource].
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
case report tabulations (CRT)
|
<b>CDISC Definition:</b> In a paper submission, listings of data that may be organized by domain (type of data) or by subject. See also eCRT.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
case-control study
|
<b>CDISC Definition:</b> A study in which individuals to an outcome (cases) are compared with those who do not have the outcome (controls). NOTE: The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
categorical data
|
<b>CDISC Definition:</b> Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
causality assessment
|
<b>CDISC Definition:</b> An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
CDISC Library
|
<b>CDISC Definition:</b> A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
CDISC standards
|
<b>CDISC Definition:</b> A set of models, implementation guides, controlled vocabularies, and exchange formats developed by the Clinical Data Interchange Standards Consortium (CDISC), which are intended to provide for consistent use of common representations of data, terms and specifications. NOTE: These standards apply to translational research, electronic submission of clinical data, and the life-cycle of clinical product development, which includes protocol representation, data collection, aggregation, tabulation, and analysis and unambiguous information exchange across disparate systems. [After https://www.ncbi.nlm.nih.gov]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
cell therapy
|
<b>CDISC Definition:</b> The prevention or treatment of human disease by the administration of cells that have been selected, multiplied, and pharmacologically treated or altered outside the body (ex vivo), or methods (pharmacological as well as nonpharmacological) to modify the function of intrinsic cells of the body for therapeutic purposes (in vivo). NOTE: Cell therapies can be classified based on therapeutic indication, cell type, source of cells, and underlying technology, among others, in medical and regulatory contexts. [After https://www.sciencedirect.com/topics/neuroscience/cell-therapy; After Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.] See also regenerative medicine therapy, regenerative medicine advanced therapy, gene therapy, biological product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
certified copy
|
<b>CDISC Definition:</b> A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. [ICH E6 (R2)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
certified IRB professional (CIP)
|
<b>CDISC Definition:</b> Persons certified to participate on an institutional review board, who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
challenge agent
|
<b>CDISC Definition:</b> A non-investigational medicinal product (NIMP) given to trial subjects to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
CHI (consolidated health informatics)
|
<b>CDISC Definition:</b> CHI began as an eGov initiative to establish a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to "speak the same language" based on common enterprise-wide business and information technology architectures. CHI is currently managed under the Office of the National Coordinator for Health Informational Technology's (ONC) Federal Health Architecture (FHA) Program Management Office. Ref: The United States Health Information Knowledgebase [USHIK]. [HITSP]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
class
|
<b>CDISC Definition:</b> A definition of objects with properties (attributes, methods, relationships) that all objects in the class have in common. [HL7, 2001] in data modeling, a class defines a set of objects that share the same attributes, relationships, and semantics. A class is usually an entity that represents a person, place, or thing.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clean database
|
<b>CDISC Definition:</b> A set of reviewed data in which errors have been resolved to meet QA requirements for error rate and in which measurements and other values are provided in acceptable units; database that is ready to be locked. See also database lock, clean file.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clean file
|
<b>CDISC Definition:</b> When all data cleaning is completed and database is ready for quality review and unblinding.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
client
|
<b>CDISC Definition:</b> A program that makes a service request of another program, usually running on a server, that fulfills the request. Web browsers (such as Firefox and Microsoft explorer) are clients that request HTML files from web servers.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical benefit
|
<b>CDISC Definition:</b> A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels. See also benefit summary, treatment benefit.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical clarification
|
<b>CDISC Definition:</b> A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical data
|
<b>CDISC Definition:</b> Data pertaining to the medical well-being or status of a patient. Category also includes clinical reports and individual patient data (IPD) as defined in the EMA Policy 0070 Implementation Guide. [http://www.ema.eoropa.eu/docs/en_GB/document_library/REPORT/2014/10/WC500174378.PDF]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical development plan
|
<b>CDISC Definition:</b> A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. NOTE: The plan should have appropriate decision points and allow modification as knowledge accumulates. [from ICH E9] See also development plan.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical document architecture
|
<b>CDISC Definition:</b> Specification for the structure and semantics of "clinical documents" for the purpose of exchange. [HL7; SPL]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical document
|
<b>CDISC Definition:</b> A documentation of clinical observations and services. NOTE: an electronic document should incorporate the following characteristics: persistence, stewardship, potential for authentication, wholeness, and human readability. [SPL]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical efficacy
|
<b>CDISC Definition:</b> Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical encounter
|
<b>CDISC Definition:</b> Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. [CDISC]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical hold (of a clinical trial)
|
<b>CDISC Definition:</b> An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (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 |
clinical investigation
|
<b>CDISC Definition:</b> Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Considered synonymous with clinical research by FDA. See clinical study, clinical trial. [FDA Science & Research]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical outcome assessment (COA) qualification
|
<b>CDISC Definition:</b> A formal conclusion by FDA that, within the stated context of use, the results of the COA measurement can be relied upon to have a specific interpretation and application. NOTE: For qualified COAs, FDA permits drug developers to use the COA in the qualified context in IND and NDA/BLA submissions without requesting that the relevant CDER review group reconsider and reconfirm the suitability of the COA. [FDA Clinical Outcome Assessment (COA) Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical outcome assessment (COA)
|
<b>CDISC Definition:</b> Any assessment that may be influenced by human choices, judgment, or motivation and may support or refute treatment benefit. NOTE: Unlike biomarkers that rely completely on an automated process or algorithm, COAs reflect interpretation of reporting from a patient, a clinician, or an observer. There are four types of COAs. See also patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO). [FDA Clinical Outcome Assessment (COA) Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical pharmacology
|
<b>CDISC Definition:</b> Science that deals with the characteristics, effects, properties, reactions, and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical research and development
|
<b>CDISC Definition:</b> The testing of a drug compound in humans primarily done to determine its safety and pharmacological effectiveness. Clinical development is done in phases, which progress from very tightly controlled dosing of a small number of subjects to less tightly controlled studies involving large numbers of patients. [SQA]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical research associate (CRA)
|
<b>CDISC Definition:</b> Person employed by a study sponsor or by a contract research organization (CRO) acting on a sponsor's behalf, who monitors the status, data integrity, and protocol adherence of investigator sites participating in a clinical study. See also sponsor.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical research coordinator (CRC)
|
<b>CDISC Definition:</b> A qualified study staff member who manages the participation of subjects according to the study protocol. NOTE: CRCs coordinate communication among the subject, investigator, and sponsor. Responsibilities may also include screening, enrollment, monitoring of potential participants, and informed consent. [After Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research Cavalieri Jennifer and Rupp Mark Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research 336pp US$44.95 Sigma Theta Tau 9781937554637 1937554635 [Formula: see text]. Nurs Manag (Harrow). 2014 Aug 28;21(5):13.; After SOCRA]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical research subject
|
<b>CDISC Definition:</b> A person who is enrolled into a clinical study or trial. See also study, trial, and study population.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical significance
|
<b>CDISC Definition:</b> Change in a subject's clinical condition regarded as important whether or not due to the test intervention. NOTE: some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol. The term "clinical significance" is not advisable unless operationally defined.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical study data element
|
<b>CDISC Definition:</b> A single observation associated with a subject in a clinical study. A data element in an eCRF represents the smallest unit of observation captured for a subject in a clinical investigation. NOTE: Examples include birth date, white blood cell count, pain severity measure, and other clinical observations made and documented during a study. Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. See also eCRF, data element identifier, data originator, item. [After FDA Guidance for Industry Electronic Source Data in Clinical Investigations , Body text and Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical study report
|
<b>CDISC Definition:</b> A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. NOTE: For further information, see the ICH Guideline for Structure and Content of Clinical Study Reports. [ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical study
|
<b>CDISC Definition:</b> A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical trial authorization
|
<b>CDISC Definition:</b> Authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction. NOTE: If an ethical committee allows a trial to proceed it is called an approval to proceed. [After ISO 11615:2017, 3.1.12]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical trial data
|
<b>CDISC Definition:</b> Data collected in the course of a clinical trial. See also clinical trial information.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical trial exemption (CTX)
|
<b>CDISC Definition:</b> A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days). NOTE: Approval means that the company is exempt from the requirement to hold a clinical trial certificate (CTC). [UK]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical trial information
|
<b>CDISC Definition:</b> Data collected in the course of a clinical trial or documentation related to the integrity or administration of that data. A superset of clinical trial data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
clinical trial materials
|
<b>CDISC Definition:</b> Complete set of supplies provided to an investigator by the trial sponsor.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
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