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ADaM | CDISC Analysis Dataset Model | |||
ADSL | (ADaM) Subject-level Analysis Dataset | |||
ATC | Anatomic Therapeutic Chemical (code; WHO) | |||
CDASH | Clinical Data Acquisition Standards Harmonization Model | |||
CDISC | Clinical Data Interchange Standards Consortium | |||
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 observations with a topic-specific commonality | |||
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 | |||
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. | |||
PRO | Patient-reported outcome | |||
QRS | Questionnaires, Ratings, and Scales | |||
SAP | Statistical analysis plan | |||
SDTMStudy Data Tabulation Model | SDTMIG-AP | Study Data Tabulation Model Implementation Guide: Associated Persons | SDTMIG-MD | Study Data Tabulation Model Implementation Guide for Medical Devices |
SEND | Standard for Exchange of Non-Clinical Data | |||
SNOMED | Systematized Nomenclature of Medicine (a dictionary) | |||
SOC | System Organ Class | |||
TDM | Trial Design Model | |||
TIG | Tobacco Implementation Guide | |||
WHODRUG | World Health Organization Drug Dictionary | |||
XML | eXtensible Markup Language |
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