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).
CDISC Dataset | 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's jurisdiction under chapter IX of the FD&C Act and submits an application to FDA for authority to market a tobacco product. |
| ATC | Anatomic Therapeutic Chemical ( |
code| 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 |
CTCAE | Common Terminology Criteria for Adverse Events| 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 |
.A In the context of the CDASH Model and the SDTM, a collection of logically related observations with a |
topic-specific commonalitycommon, 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 |
| HL7 | Health Level 7 |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| ICH E2A | ICH guidelines on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| ICH E2B | ICH guidelines on Clinical Safety Data Management: Data Elements for Transmission of Individual Cases Safety Reports |
| ICH E3 | ICH guidelines on Structure and Content of Clinical Study Reports |
| 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 |
ICH E9 | ICH guidelines on Statistical Principles for Clinical Trials |
| 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 |
ISO 3166 | ISO codelist for representing countries; the Alpha-3 codelist uses 3-character codes., Identifiers, Names, and Codes| 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 |
(NIH) |
| 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 |
| PRO | Patient-reported outcome |
| SAP | Statistical analysis plan |
| SDS | Submission Data Standards. Also the name of the team that created the SDTM and SDTMIG. |
| SDTM | Study Data Tabulation Model |
| SDTMIG | Study Data Tabulation Model Implementation Guide: Human Clinical Trials [this document] |
| SDTMIG-AP | Study Data Tabulation Model Implementation Guide: Associated Persons |
| SDTMIG-MD | Study Data Tabulation Model Implementation Guide for Medical Devices |
| 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 |
SDTMIG-PGx | Study Data Tabulation Model Implementation Guide: Pharmacogenomics/Genetics |
| SEND | Standard for Exchange of |
Non-Clinical SNOMED | |
| SENDIG | SEND Implementation Guide |
| SI | International System of Units |
| SMQ | Standardized MedDRA query |
Systematized Nomenclature of Medicine (a dictionary)| TDM | Trial Design Model |
| WHODRUG | World Health Organization Drug Dictionary |
XML | eXtensible Markup Language |
| 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 |