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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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