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de-identification
|
<b>CDISC Definition:</b> The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization.
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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 |
de-identified information
|
<b>CDISC Definition:</b> Records that have had enough personally identifiable information removed or obscured such that the remaining information does not identify an individual, and there is no reasonable basis to believe that the information can be used to identify an individual. [Guide to Protecting Personally Identifiable Information (PII): Special Publication NIST pubs/800-122]
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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 |
decentralized clinical trial (DCT)
|
<b>CDISC Definition:</b> A trial in which data capture, administration of medication, and possibly other procedures are done at the subject's location, e.g., at home or by telemedicine, mobile technology, and local HCPs (like family physicians, general practitioners). NOTE: The procedures (entry of data, medical tests, clinical evaluations, objective measures, observations) for capturing safety and efficacy measurements and observations may be done in-person by a traveling clinician or nurse so DCTs are not necessarily virtual. The responsibility for preparation, maintenance and retention of source records may be allocated to a centralized investigator or sponsor investigator. [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also remote clinical trial, virtual, visit.
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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 |
decision rule
|
<b>CDISC Definition:</b> Succinct statement of how a decision will be reached based upon the expected foreseen clinical benefits in terms of outcomes of the primary endpoint. [FDA documentation]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Declaration of Helsinki
|
<b>CDISC Definition:</b> A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. it was originally adopted by the 18th World Medical assembly (Helsinki, Finland, 1964) and recently revised (64th WMA General Assembly, Fortaleza, Brazil, October 2013).
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
deep learning
|
<b>CDISC Definition:</b> A subset of machine learning that is part of the broader family of machine learning methodologies based on artificial neural networks. A deep neural network has multiple layers between input and output layers to progressively extract higher level features from the raw input. [After DeepAI Machine Learning Glossary and Terms] See also machine learning, artificial intelligence (AI).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Define-XML
|
<b>CDISC Definition:</b> A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language).
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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 |
demographic data
|
<b>CDISC Definition:</b> Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.
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[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
dependent variable
|
<b>CDISC Definition:</b> A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
deployment
|
<b>CDISC Definition:</b> Readying an electronic clinical trial system for field use by providing or disseminating capture devices, tokens, or passwords for users of an activated system. See activation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
derived variable
|
<b>CDISC Definition:</b> New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
design configuration
|
<b>CDISC Definition:</b> Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9]
|
[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
development plan
|
<b>CDISC Definition:</b> An ordered program of clinical trials, each with specific objectives. [adapted from ICH E9, see ICH E8]. See also clinical development plan.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
diagnose
|
<b>CDISC Definition:</b> A process to identify the disease, condition, or injury that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After \"Making a diagnosis\", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease, sign, symptom.
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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 |
diagnostic device
|
<b>CDISC Definition:</b> A class of medical devices intended to provide evidence for diagnosis. [After Regulation (EU) 2017/745; After US FDA, Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents, Nov 14, 2022] See also medical device, investigational device, in vitro diagnostic device.
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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 |
DIBD (development international birth date)
|
<b>CDISC Definition:</b> The sponsor's first authorization to conduct a clinical trial in any country worldwide. NOTE: Used to start the annual period for the Development Safety Update Report (DSUR). [After CIOMS VII; ICH E2F]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
digital signature
|
<b>CDISC Definition:</b> An electronic signature, based on cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters, such that the identity of the signer and the integrity of the data can be verified. [21 CFR 11]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
direct access
|
<b>CDISC Definition:</b> Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. NOTE: The party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. [ICH E6 Glossary]
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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 |
direct entry
|
<b>CDISC Definition:</b> Recording of data by human or automated action where an electronic record is the original means of capturing the data into an electronic records system without a paper source document. Examples are an individual keying original observations into a system or the automatic recording into the system of the output from measuring devices such as a balance that measures subject's body weight or an ECG machine. Compare to data entry, data acquisition.
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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 |
direct identifier
|
<b>CDISC Definition:</b> A piece of data that can be used to uniquely identify an individual (e.g., name, patient ID, social security number, exact address, telephone number, e-mail address, government issued identifiers, passport/VISA numbers) either without additional information or with cross-linking through other information that is in the public domain. [After PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.]
|
[
"CDISC Glossary.xlsx"
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excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
discontinuation
|
<b>CDISC Definition:</b> The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] See also withdrawal.
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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 |
discrepancy
|
<b>CDISC Definition:</b> The failure of a data point to pass a validation check. NOTE: Discrepancies may be detected by computerized edit checks or observed/ identified by the data reviewer as a result of manual data review. See also query.
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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 |
disease
|
<b>CDISC Definition:</b> Any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the affected person. NOTE: The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. [After NCI Thesaurus] See also diagnosis.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
disease-free survival
|
<b>CDISC Definition:</b> The length of time after treatment for a specific disease during which a patient survives with no sign of recurrence of the disease. [NCI]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
document (HL7)
|
<b>CDISC Definition:</b> An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures. Descriptors for HL7 documents include type, class, and element. NOTE: In HL7, a document can be either physical (referring to the paper) or logical (referring to the content) with the following characteristics: 1) Stewardship; 2) Potential for authentication; 3) Wholeness; 4) Human readability; 5) Persistence; 6) Global vs. local context.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
document root
|
<b>CDISC Definition:</b> The element in an XML document that contains all other elements; the first element in the document. [SPL Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
document type definition (DTD)
|
<b>CDISC Definition:</b> XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document. NOTE: Agreeing on a common DTD facilitates interoperability among systems incorporating the agreed standards. [From Electronic Submission File Formats and Specifications. Orientation and Best Practices For Data Formats and Submission to The Center For Tobacco Products. January 2018; Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry. January 2019]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
documentation
|
<b>CDISC Definition:</b> All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. [ICH E6 Glossary]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
domain name
|
<b>CDISC Definition:</b> The way a particular web server is identified on the internet. For example, www.fda.gov names the World Wide Web (www) server for the Food and Drug administration, which is a government (.gov) entity. [Center for advancement of Clinical Research]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
domain
|
<b>CDISC Definition:</b> A collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation. NOTE: The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Example domains include laboratory test results (LB), adverse events (AE), concomitant medications (CM). [After SDTM Implementation Guide version 3.2, CDISC.org] See also general observation class.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
dosage form
|
<b>CDISC Definition:</b> Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. [After 21 CFR 314.3; After IDMP] See also drug product.
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
dosage regimen
|
<b>CDISC Definition:</b> The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
dosage
|
<b>CDISC Definition:</b> The amount of drug administered to a patient or test subject over a period of time; a regulated time bound administration of individual doses. NOTE: For example, a daily dosage specified in a prescription or a clinical trial, such as one 100mg tablet taken 4 times per day. [After AMA Manual of style]
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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 |
dose strength
|
<b>CDISC Definition:</b> The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]
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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 |
dose
|
<b>CDISC Definition:</b> Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics]
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[
"CDISC Glossary.xlsx"
] | null |
excel
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CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
dose-escalation trial
|
<b>CDISC Definition:</b> A study in which the dosage of the test article is increased until the desired physiological effect or toxicity is seen. (CDISC; After ICH E4)
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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 |
double-blind study
|
<b>CDISC Definition:</b> A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms]
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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 |
double-dummy
|
<b>CDISC Definition:</b> A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. supplies are prepared for Treatment a (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). subjects then take two sets of treatment; either a (active) and B (placebo), or a (placebo) and B (active). [ICH E9]
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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 |
dropout
|
<b>CDISC Definition:</b> A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol. [from ICH E9]
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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 |
drug development process
|
<b>CDISC Definition:</b> The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.
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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 |
drug distribution
|
<b>CDISC Definition:</b> In pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other tissues. See also ADME.
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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 |
drug interaction
|
<b>CDISC Definition:</b> Changes in a drug's effects due to recent or concurrent use of another drug or drugs (drug-drug interactions), ingestion of food (drug-nutrient interactions), or ingestion of dietary supplements (dietary supplement-drug interactions). [MSD Manual Professional Version. Drug Interactions. By Shalini S. Lynch , PharmD, University of California San Francisco School of Pharmacy. Reviewed/Revised Jul 2022; Modified Sep 2022. Merck & Co, Inc., Rahway, NJ, USA] See also additive effect, synergistic effect, antagonistic effect.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
drug product
|
<b>CDISC Definition:</b> A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21 CFR 210.3] See also medicinal product, dosage form.
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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 |
drug treatment
|
<b>CDISC Definition:</b> A drug given to a patient to mitigate or cure an illness, injury, or reduced health status. See also drug, treatment, intervention.
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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 |
drug
|
<b>CDISC Definition:</b> An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance.
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[
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
dynamic HTML
|
<b>CDISC Definition:</b> Collective term for a combination of tags and options, style sheets, and programming that allows users to create web pages in hypertext Mark-up language (HTML) that are more responsive to user interaction than previous versions of HTML.
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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 |
Early Phase I
|
<b>CDISC Definition:</b> Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase.
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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 |
early termination of trial
|
<b>CDISC Definition:</b> The premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with. [REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC; ICH E6] See also termination (of a clinical trial).
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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 |
eCertified copy
|
<b>CDISC Definition:</b> A copy of an electronic record that is created through the application of a process validated to preserve the data and metadata of the original and where the validation of the process is certified by the dated signature of an authorized person. [CDISC, after EMA/INS/GCP/454280/2010 GCP Inspectors Working Group (GCP IWG) June 2010]
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
eClinical trial
|
<b>CDISC Definition:</b> Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial.
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
eConsent form
|
<b>CDISC Definition:</b> An electronic document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian. [NCI] See also informed consent, consent form, electronic signature.
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
eCRF (electronic case report form)
|
<b>CDISC Definition:</b> An auditable electronic record of information that is reported to the sponsor (or sponsor's agent such as an EDC provider) on each trial subject to enable data pertaining to a clinical investigation protocol to be systematically captured, reviewed, managed, stored, analyzed, and reported. The eCRF is a CRF in which related data items and their associated comments, notes, and signatures are linked programmatically. See also case report form, CRF, eSRF.[CSUICI; Revised from FDA Final Guidance on eSource]
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excel
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CDISC Glossary.xlsx
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Glossary Terminology 2025-09-26
| null |
eCRT (electronic case report tabulation)
|
<b>CDISC Definition:</b> Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format.
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excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
EDC (electronic data capture)
|
<b>CDISC Definition:</b> The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
edit check
|
<b>CDISC Definition:</b> An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range, or other properties that is intended to reduce error. NOTE: Time-of-entry edit checks are a type of edit check that is run (executed) at the time data are first captured or transcribed to an electronic device at the time entry is completed of each field or group of fields on a form. Back-end edit checks are a type that is run against data that has been entered or captured electronically and has also been received by a centralized data store.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
EDR (electronic document room)
|
<b>CDISC Definition:</b> The electronic document room is an extension of the e-Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
effect size
|
<b>CDISC Definition:</b> A measure or estimate of the observed or expected change in an outcome as a result of an intervention. [After AMA Manual of Style]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
effectiveness
|
<b>CDISC Definition:</b> A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
efficacy
|
<b>CDISC Definition:</b> A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
EHR (electronic health record)
|
<b>CDISC Definition:</b> An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. NOTE: The EHR has the following distinguishing features: able to be obtained from multiple sources; shareable; interoperable; accessible to authorized parties. [After National Office of Health Information Technology-HIT, USHHS]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
electronic data transfer
|
<b>CDISC Definition:</b> The exchange of data across computer systems and networks, taking into account all required quality aspects such as security, data privacy, data quality, data integrity, and audit trail. [After FDA 21 CFR Part 11; After Guideline on computerized systems and electronic data in clinical trials (europa.eu) EMA/INS/GCP/112288/2023] See also data security, data quality, data integrity, data entry, ALCOA++.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
electronic personal health record (ePHR)
|
<b>CDISC Definition:</b> An electronic record for individuals to create, import, store, and use clinical information to support their own health.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
electronic record
|
<b>CDISC Definition:</b> Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. [21 CFR 11.3(b) (6)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
electronic signature
|
<b>CDISC Definition:</b> A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7); After US FDA Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application, Aug 2003] See also eConsent form.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
eligibility criteria
|
<b>CDISC Definition:</b> Requirements that must be met for a person to be included in a study, which help make sure that the results of the study are caused by the intervention being tested and not by other factors. NOTE: Eligibility Criteria, including inclusion and exclusion criteria, should enable constitution of the targeted cohorts in the clinical study. [After NCI's Dictionary of Cancer Terms]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
emergency use authorization
|
<b>CDISC Definition:</b> Approval by FDA for the emergency use of certain unapproved medical products or an unapproved use of an approved medical product for certain emergency circumstances, when applied for under a declared health emergency. These medical products may be referred to as medical countermeasures (MCMs) and may include drugs, biologics, and devices. [After Emergency Use Authorization of Medical Products and Related Authorities. FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval access.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
EMR (electronic medical record)
|
<b>CDISC Definition:</b> An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
end-point assessment medicinal product
|
<b>CDISC Definition:</b> Medicinal products given to the subject as an aid to assess a relevant clinical trial end-point; it is not being tested or used as a reference in the clinical trial. [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 |
endemic disease
|
<b>CDISC Definition:</b> The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
endpoint
|
<b>CDISC Definition:</b> A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
enrolled
|
<b>CDISC Definition:</b> Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., Clinicaltrials.gov. See also informed consent, enrollment.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
enrollment (cumulative)
|
<b>CDISC Definition:</b> Current enrollment including any subjects who were once enrolled and have ended participation.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
enrollment (current)
|
<b>CDISC Definition:</b> Subjects actively continuing to participate in a clinical trial as of the current date.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
enrollment
|
<b>CDISC Definition:</b> The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
epidemic
|
<b>CDISC Definition:</b> The occurrence in a community or region of cases of an illness, specific health-related behavior, or other health-related events clearly in excess of normal expectancy. NOTE: The community or region and the period in which the cases occur are specified precisely. The number of cases indicating the presence of an epidemic varies according to the agent, size, and type of population exposed; previous experience or lack of exposure to the disease; and time and place of occurrence. [After A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, OXFORD UNIVERSITY PRESS 2001]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
epoch
|
<b>CDISC Definition:</b> Planned interval of time in the conduct of a study wherein an activity is specified and consistent, e.g., specific treatment dose or study activity such as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period defined in the protocol with a study-specific purpose. See also arm, visit, phase (within a study).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
ePRO
|
<b>CDISC Definition:</b> Patient reported outcome data initially captured electronically. NOTE: Usually ePRO data is captured as eSource. [DIA ePRO Working Group]. See also patient reported outcome, PRO, eSource.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
equipoise
|
<b>CDISC Definition:</b> A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. NOTE: An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
equivalence trial
|
<b>CDISC Definition:</b> A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant. NOTE: This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
equivalent effect
|
<b>CDISC Definition:</b> An effect of two or more bioactive compounds or drugs that is deemed to be equal, and can be expected to have the same clinical effect and safety profile. [After US FDA, Evaluation of Therapeutic Equivalence, Draft Guidance for Industry, July 2022]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
eSource data
|
<b>CDISC Definition:</b> Source data captured initially into a permanent electronic record (eSource document) used for the reconstruction and evaluation of a clinical study or a source data item included in an eCRF when direct entry is made. NOTE: permanent in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also eSource document, source data, permanent data, data originator. [From body of FDA Final Guidance on eSource]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
eSource document
|
<b>CDISC Definition:</b> Electronic record containing source data for a clinical trial, used to aggregate a particular instance of eSource data items for capture, transmission, storage, and/ or display, and serving as a source document for a clinical investigation. NOTE: Electronic Source documents are recorded in electronic systems according to conventions (such as those for PDF documents) that ensure that all the fields of eSource data and associated contextual information (e.g. time of capture, time zone, authorship, origin, signatures, revisions, etc.) are linked to each other in a particular structure for presentation. The encoded specifications in the electronic record thus serve the same role as have the physical properties of paper (binding data items together). eSource documents are subject to regulations and guidance that apply to source documents. See also source documents. [relevant to FDA Final Guidance on eSource]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
eSource
|
<b>CDISC Definition:</b> Source record that is electronic. See also source, electronic record.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
eSRF (electronic source report form)
|
<b>CDISC Definition:</b> The human-readable rendering of an electronic record serving as an eSource document that is part of a case history. The eSRF supports capture, transmission, storage, editing and/ or display of eSource documents (original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation) used for reconstructing and evaluating the investigation. NOTE: Intended use distinguishes eCRF and eSRF. The eCRF is for capture, review and editing of protocol data belonging to the sponsor; the eSRF is for the human-readable representation of the eSource document for review or to maintain the eSource document that is part of the case history under 21CFR312.62. See also eCRF, eSource document. [CDISC, relevant to FDA Final Guidance on eSource]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
essential documents
|
<b>CDISC Definition:</b> Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. [ICH E6 Glossary]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
established name
|
<b>CDISC Definition:</b> The official name of a drug or pharmaceutical product, relevant in US regulations. [US FDA, 21 CFR 299.4] See also proprietary name, generic name, international nonproprietary name (INN), medicinal product name, compendial name.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
estimand
|
<b>CDISC Definition:</b> A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarizes at a population level what the outcomes would be in the same patients under different treatment conditions being compared. NOTE: The four characteristics of an estimand include the definition of the target study population, statement of the endpoint of interest, intercurrent event details, and the population level summary of the variable of interest. (ICH E9 R1 Addendum; After Estimand Framework: What it is and Why You Need it. Applied Clinical Trials. February 27, 2020]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
ethics committee
|
<b>CDISC Definition:</b> Group convened to protect research subjects. NOTE: Such bodies, depending on the country or region, are abbreviated as: CCI, CCPPRB, CHR, CPPHS, CRB, EAB, HEX, HSRC, LREC, MREC, NIRB, NRB, and REB. See also institutional review board, independent ethics committee.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
ethnicity
|
<b>CDISC Definition:</b> Denotes social groups with a shared history, sense of identity, geography, and cultural roots.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
European Medicines Agency (EMA)
|
<b>CDISC Definition:</b> The regulatory agency for the EU.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
evaluable (for efficacy and safety)
|
<b>CDISC Definition:</b> Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
event
|
<b>CDISC Definition:</b> Planned protocol activities such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). [After SDTM, www.cdisc.org] See also general observation class, intervention, finding.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
exclusion criteria
|
<b>CDISC Definition:</b> List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
excretion
|
<b>CDISC Definition:</b> The act or process of eliminating waste products from the body. See also ADME.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
expansion cohort trial
|
<b>CDISC Definition:</b> A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
experimental intervention
|
<b>CDISC Definition:</b> The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). NOTE: This does not include comparators or placebos. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis, investigational medicinal product.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
experimental unit
|
<b>CDISC Definition:</b> A physical entity which is the primary interest in a specific research objective. NOTE: Depending on the research objectives, a single study may have multiple levels of experimental units. Commonly the individual study subject (animal, person or product) is the experimental unit. (BRIDG v5.3)
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
exploratory IND study
|
<b>CDISC Definition:</b> A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
exploratory objective
|
<b>CDISC Definition:</b> Additional scientific question(s) within the study that enable further discovery research, beyond the primary and secondary objectives. See also objective, primary objective, secondary objective.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
exploratory study
|
<b>CDISC Definition:</b> Phase 1 or 2 study during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in exploratory studies may appropriately be altered beyond the standard adequate and well controlled processes to expand the scope or method of investigation. [NOTE: After FDA eCOA Glossary] Compare to confirmatory study.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
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