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The following table lists some of the terms and abbreviations and terms are used in this documentguide. Additional definitions can be found in the individual sections of this document (see esp. Section 7.1.2, Definitions of Trial Design Concepts (Copy)) and in the CDISC Glossary (available at https://www.cdisc.org/standards/glossary).


aCRFAnnotated CRF
ADaM
CDISC
Analysis
Dataset
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 (
code
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
CTCAECommon Terminology Criteria for Adverse Events
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
A

In the context of the CDASH Model and the SDTM, a collection of logically related observations with a

topic-specific commonality

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
HL7Health Level 7ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseICH E2AICH guidelines on Clinical Safety Data Management: Definitions and Standards for Expedited ReportingICH E2BICH guidelines on Clinical Safety Data Management: Data Elements for Transmission of Individual Cases Safety ReportsICH E3ICH guidelines on Structure and Content of Clinical Study Reports
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
ICH E9ICH guidelines on Statistical Principles for Clinical Trials
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
ISO 3166ISO codelist for representing countries; the Alpha-3 codelist uses 3-character codes.
LOINCLogical Observation
, Identifiers, Names, and Codes
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
(NIH)
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
PROPatient-reported outcomeSAPStatistical analysis planSDSSubmission Data Standards. Also the name of the team that created the SDTM and SDTMIG.SDTMStudy Data Tabulation ModelSDTMIGStudy Data Tabulation Model Implementation Guide: Human Clinical Trials [this document]SDTMIG-APStudy Data Tabulation Model Implementation Guide: Associated PersonsSDTMIG-MDStudy Data Tabulation Model Implementation Guide for Medical Devices
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
SDTMIG-PGxStudy Data Tabulation Model Implementation Guide: Pharmacogenomics/Genetics
SENDStandard for Exchange of
Non-Clinical
Nonclinical Data
SNOMED
SENDIGSEND Implementation Guide
SIInternational System of Units
SMQStandardized MedDRA query
Systematized Nomenclature of Medicine (a dictionary)
SOCSystem organ class
TDMTrial Design ModelWHODRUGWorld Health Organization Drug DictionaryXMLeXtensible Markup Language
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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