The following table lists some of the terms and abbreviations used in this guide. Additional definitions can be found in the individual sections of this document and in the CDISC Glossary (available at https://www.cdisc.org/standards/glossary).


aCRFAnnotated CRF
ADaMAnalysis Data Model
ADaMIGADaM Implementation Guide
ADSL(ADaM) Subject-level Analysis Dataset
Applicant

Any party, which may include the tobacco manufacturer and its authorized representative, who is subject to FDA's jurisdiction under chapter IX of the FD&C Act and submits an application to FDA for authority to market a tobacco product.

ATCAnatomic Therapeutic Chemical (classification system; WHO)
BMIBody mass index
BQLBelow limit of quantification
CASChemical Abstracts Service (a division of the American Chemical Society)
CDASHClinical Data Acquisition Standards Harmonization (Model)
CDASHIGCDASH Implementation Guide
CDISCClinical Data Interchange Standards Consortium
CQCustomized (MedDRA) query
ConformanceRefers to whether implementation of standards per this guide meets the requirements of the standards
CRFCase report form (sometimes case record form). In this guide, CRF refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
CROContract research organization
CTP(US FDA) Center for Tobacco Products
DAO Data as observed
DatasetA collection of structured data in a single file
Data collection field(s)

Data elements that are commonly on a CRF

Data collection variable(s)

Data elements stored in an EDC system

Define-XMLCDISC standard for transmitting metadata that describes any tabular dataset structure
Domain

In the context of the CDASH Model and the SDTM, a collection of logically related observations with a common, specific topic. The logic of the relationship may pertain to the scientific subject matter of the data or its role in a study or trial.

ECGElectrocardiogram
EDCElectronic data capture (sometimes collection)
eDTElectronic data transfer
ENDSElectronic nicotine delivery systems
EVS(NCI) Enterprise Vocabulary Services
FDA(US) Food and Drug Administration
GLPGood laboratory practice
HPHCHarmful and potentially harmful constituents
HTPHeated tobacco product
General observation classA high-level categorization of the subject-level observation domains defined and used to group domains in the SDTM
ISOInternational Organization for Standardization
ISO 8601ISO character representation of dates, date/times, intervals, and durations of time. The SDTM uses the extended format.
IUPACInternational Union of Pure and Applied Chemistry (developer of chemical nomenclature and terminology)
IVRSInteractive voice response system
LOCFLast observation carried forward
LOINCLogical Observation Identifiers Names and Codes
Mechanisms for data collectionDifferent approaches used to control how data are collected (e.g., on a CRF) including tick boxes, checkboxes, radio buttons, and drop-down lists
MedDRAMedical Dictionary for Regulatory Activities
MRIMagnetic resonance imaging
Nonclinical studyA scientific experiment, typically involving animal subjects, which is intended to address certain scientific questions that are the objectives of the study
NCI(NIH) National Cancer Institute
NHKNormal human keratinocytes
NIH(US) National Institutes of Health
NNNN-nitrosonornicotine
NRSNumeric rating scale
NSVNon-standard variable; in the context of standards for tabulation, an NSV is a variable which is not defined in the SDTM
NullIn the context of populating a value in a variable, null indicates no value will be populated.
ObservationAn observation refers to a discrete piece of information collected during a study (e.g., a vital sign measured/observed for a specific subject at a specific time as part of a study)
ODMOperational Data Model
PBSPhosphate-buffered saline
PKPharmacokinetic
PMTAPremarket tobacco product applications (rule)
QRSQuestionnaires, ratings, and scales
SAPStatistical analysis plan
SDTMStudy Data Tabulation Model
SDTMIGSDTM Implementation Guide
SENDStandard for Exchange of Nonclinical Data
SENDIGSEND Implementation Guide
SIInternational System of Units
SMQStandardized MedDRA query
SOCSystem organ class
STN(FDA) Submission tracking number 
TIGTobacco Implementation Guide
TKToxicokinetics
TNETotal nicotine equivalents
UUIDUniversally unique identifier
VASVisual analog scale
WHOWorld Health Organization
WHODrug(WHO) Global medicinal information dictionary
XMLExtensible markup language

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