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| 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 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 | Electronic Data Capture | ||
| eDT | Electronic data transferData Transfer | ||
| FDA-CTP | (US) Food and Drug Administration Center for Tobacco Products | General Observation Class | In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. See also domain, event, intervention, finding. Compare with special purpose domain. also add other datasets/models from SDTM to glossary |
| 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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