The following table lists some of the terms and abbreviations and terms used in this documentguide. 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).
| Num | Language | Refers to: |
|---|
| 1 | CRF | - Both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
|
2 | - Data elements that are commonly on the CRF.
| 3 | 4 | | | ADaM | CDISC Analysis Dataset Model |
| 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'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. |
CTCAE | Common Terminology Criteria for Adverse Events| CRO | Contract research organization |
| CTP | (US FDA) Center for Tobacco Products |
| DAO | Data as observed |
| Dataset | A collection of structured data in a single file |
| Data |
Collection Field| collection field(s) | Data elements that are commonly on a CRF |
. Collection Variable| collection variable(s) | Data elements stored in an |
electronic data capture () . |
| 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 |
| GLP | Good laboratory practice |
| HPHC | Harmful and |
Potentially Harmful Constituents| 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 |
| ISO 3166 | ISO codelist for representing countries; the Alpha-3 codelist uses 3-character 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 |
| PRO | Patient-reported outcome |
| SAP | Statistical analysis plan |
| SDTM | Study Data Tabulation Model |
| SDTMIG-AP | Study Data Tabulation Model Implementation Guide: Associated Persons |
|
| 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 |
SDTMIG-MD | Study Data Tabulation Model Implementation Guide for Medical Devices |
| 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) Organ ClassTDM | Trial Design Model| STN | (FDA) Submission tracking number |
| TIG | Tobacco Implementation Guide |
WHODRUG |
| TK | Toxicokinetics |
| TNE | Total nicotine equivalents |
| UUID | Universally unique identifier |
| VAS | Visual analog scale |
| WHO | World Health Organization |
Drug Dictionary |
| WHODrug | (WHO) Global medicinal information dictionary |
| XML |
eXtensible Markup Language| Extensible markup language |