Glossary
Terms and definitions used in Trial Submission Studio and CDISC standards.
A
ADaM
Analysis Data Model - CDISC standard for analysis-ready datasets derived from SDTM data.
ADSL
ADaM Subject-Level - ADaM dataset containing one record per subject with demographics and key variables.
B
BDS
Basic Data Structure - An ADaM structure used for parameter-based data like vital signs and lab results.
C
CDISC
Clinical Data Interchange Standards Consortium - Organization that develops global data standards for clinical research.
Codelist
A defined set of valid values for a variable. Also known as controlled terminology.
Controlled Terminology (CT)
Standardized sets of terms and codes published by CDISC for use in SDTM and ADaM datasets.
D
Dataset-XML
A CDISC standard XML format for representing tabular clinical data.
Define-XML
An XML standard for describing the structure and content of clinical trial datasets. Required for FDA submissions.
Domain
A logical grouping of SDTM data organized by observation type (e.g., DM for Demographics, AE for Adverse Events).
DM
Demographics - SDTM domain containing one record per subject with demographic information.
E
eCTD
Electronic Common Technical Document - Standard format for regulatory submissions.
F
FDA
Food and Drug Administration - US regulatory agency that requires CDISC standards for drug submissions.
Findings Class
SDTM observation class for collected measurements and test results (e.g., Labs, Vital Signs).
I
ISO 8601
International standard for date and time formats. SDTM uses ISO 8601 format: YYYY-MM-DD.
Interventions Class
SDTM observation class for treatments given to subjects (e.g., Exposure, Concomitant Medications).
M
MedDRA
Medical Dictionary for Regulatory Activities - Standard medical terminology for adverse events.
Metadata
Data that describes other data. In Define-XML, metadata describes dataset structure and variable definitions.
O
ODM
Operational Data Model - CDISC standard for representing clinical data and metadata in XML.
P
PMDA
Pharmaceuticals and Medical Devices Agency - Japanese regulatory agency that requires CDISC standards.
S
SAS Transport (XPT)
File format for SAS datasets used for FDA submissions. See XPT.
SDTM
Study Data Tabulation Model - CDISC standard structure for organizing clinical trial data.
SDTM-IG
SDTM Implementation Guide - Detailed guidance for implementing SDTM, including variable definitions and business rules.
SEND
Standard for Exchange of Nonclinical Data - CDISC standard for nonclinical (animal) study data.
Special Purpose Domain
SDTM domains that don’t fit standard observation classes (e.g., DM, Trial Design domains).
STUDYID
Standard SDTM variable containing the unique study identifier.
U
USUBJID
Unique Subject Identifier - Standard SDTM variable that uniquely identifies each subject across all studies.
V
Variable
An individual data element within a dataset. In SDTM, variables have standard names, labels, and data types.
X
XPT
SAS Transport Format - Binary file format used to transport SAS datasets. Required by FDA for data submissions.
XPT V5
Original SAS Transport format with 8-character variable names.
XPT V8
Extended SAS Transport format supporting 32-character variable names.
Numbers
–DTC Variables
SDTM timing variables containing dates/times in ISO 8601 format (e.g., AESTDTC, VSDTC).
–SEQ Variables
SDTM sequence variables providing unique record identifiers within a domain (e.g., AESEQ, VSSEQ).
–TESTCD Variables
SDTM test code variables in Findings domains (e.g., VSTESTCD, LBTESTCD).