The following table lists some of the terms and abbreviations used in this guide. 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).
| ADaM | CDISC Analysis Dataset Model |
| ADSL | (ADaM) Subject-level Analysis Dataset |
| Applicant | An individual, company, institution, or organization that takes responsibility for a submission of a tobacco product study data to a regulatory authority, such as FDA-CTP |
| ATC | Anatomic Therapeutic Chemical (code; WHO) |
| CDASH | Clinical Data Acquisition Standards Harmonization Model |
| CDISC | Clinical Data Interchange Standards Consortium |
| Clinical Trial | A scientific experiment involving human subjects, intended to address certain scientific questions (i.e., the objectives of the trial). |
| 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 |
| 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 electronic data capture (EDC) system. |
| Define-XML | CDISC standard for transmitting metadata that describes any tabular dataset structure. |
| Domain | 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. |
| EDC | |
| eDT | Electronic data transfer |
| FDA-CTP | (US) Food and Drug Administration Center for Tobacco Products |
| HPHC | Harmful and Potentially Harmful Constituents |
| General Observation Class | A higher 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. |
| 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 |
| Nonclinical Study | A scientific experiment, typically involving animal subjects, which is intended to address certain scientific questions that are the objectives of the study. |
| NSV | Nonstandard Variable; in the context of standards for tabulation, a nonstandard variable 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. |
| Parent Dataset | |
| QRS | Questionnaires, Ratings, and Scales |
| SAP | Statistical analysis plan |
| SDTM | Study Data Tabulation Model |
| SEND | Standard for Exchange of Non-Clinical Data |
| SNOMED | Systematized Nomenclature of Medicine (a dictionary) |
| SOC | System Organ Class |
| Subject | Refers both to a person who participates in a study or trial or an animal in the context of an in vivo study |
| TDM | Trial Design Model |
| TIG | Tobacco Implementation Guide |
| WHODRUG | World Health Organization Drug Dictionary |
| XML | eXtensible Markup Language |
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