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aCRF | Annotated CRF |
ADaM | Analysis Data Model |
ADaMIG | ADaM 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’sFDA's jurisdiction under Chapterchapter IX of the Federal Food, Drug, and CosmeticFD&C Act and whichsubmits an application to FDA for authority to market a tobacco product. |
ATC | Anatomic Therapeutic Chemical (classification system; WHO) |
BMI | Body mass index |
BQL | Below limit of quantification |
CAS | Chemical Abstracts Service (a division of the American Chemical Society) |
CDASH | Clinical Data Acquisition Standards Harmonization (Model) |
CDASHIG | CDASH Implementation Guide |
CDISC | Clinical Data Interchange Standards Consortium |
CQ | Customized (MedDRA) query |
Conformance | Refers to whether implementation of standards per this guide meets the requirements of the standards |
CRF | Case report form (sometimes case record form). In this guide, CRF refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified. |
CRO | Contract research organization |
CT | Computed tomography (scan) |
CTP | (US FDA) Center for Tobacco Products |
DAO | Data as observed |
Dataset | A 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-XML | CDISC 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. |
ECG | Electrocardiogram |
EDC | Electronic data capture (sometimes collection) |
eDT | Electronic data transfer |
ENDS | Electronic nicotine delivery systems |
EVS | (NCI) Enterprise Vocabulary Services |
FDA | (US) Food and Drug Administration |
GLP | Good laboratory practice |
HPHC | Harmful and potentially harmful constituents |
HTP | Heated tobacco product |
General observation class | A high-level categorization of the subject-level observation domains defined and used to group domains in the SDTM |
ISO | International Organization for Standardization |
ISO 8601 | ISO character representation of dates, date/times, intervals, and durations of time. The SDTM uses the extended format. |
IUPAC | International Union of Pure and Applied Chemistry (developer of chemical nomenclature and terminology) |
IVRS | Interactive voice response system |
LOCF | Last observation carried forward |
LOINC | Logical Observation Identifiers Names and Codes |
Mechanisms for data collection | Different approaches used to control how data are collected (e.g., on a CRF) including tick boxes, checkboxes, radio buttons, and drop-down lists |
MedDRA | Medical Dictionary for Regulatory Activities |
MRI | Magnetic resonance imaging |
Nonclinical study | A 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 |
NHK | Normal human keratinocytes |
NIH | (US) National Institutes of Health |
NNN | N-nitrosonornicotine |
NRS | Numeric rating scale |
NSV | Non-standard variable; in the context of standards for tabulation, an NSV is a variable which is not defined in the SDTM |
Null | In the context of populating a value in a variable, null indicates no value will be populated. |
Observation | An 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) |
ODM | Operational Data Model |
PBS | Phosphate-buffered saline |
PK | Pharmacokinetic |
PMTA | Premarket tobacco product applications (rule) |
QRS | Questionnaires, ratings, and scales |
SAP | Statistical analysis plan |
SDTM | Study Data Tabulation Model |
SDTMIG | SDTM Implementation Guide |
SEND | Standard for Exchange of Nonclinical Data |
SENDIG | SEND Implementation Guide |
SI | International System of Units |
SMQ | Standardized MedDRA query |
SOC | System organ class |
STN | (FDA) Submission tracking number |
TIG | Tobacco Implementation Guide |
TK | Toxicokinetics |
TNE | Total nicotine equivalents |
UUID | Universally unique identifier |
VAS | Visual analog scale |
WHO | World Health Organization |
WHODrug | (WHO) Global medicinal information dictionary |
XML | Extensible markup language |
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