The following abbreviations and terms are used in this document. 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.

ACE

Angiotensin-converting enzyme

ADaM

Analysis Data Model

ADaMIG

ADaM Implementation Guide

ADSL

ADaM Subject-level Analysis (dataset)

AMA

American Medical Association

ARM

Analysis results metadata

BDS

(ADaM) Basic Data Structure (dataset)

BSA

Body surface area

CDISC

Clinical Data Interchange Standards Consortium

DMD

Duchenne muscular dystrophy

Domain

A collection of observations with a topic-specific commonality about a subject

LGE

Late gadolinium enhancement

LVEF

Left ventricular ejection fraction

MRI

Magnetic resonance imaging

NCI EVS

National Cancer Institute (NCI) Enterprise Vocabulary Services

NIH

National Institutes of Health

NSV

Non-standard variabvle

Patient

A recipient of medical treatment

SAP

Statistical analysis plan

SDTM

Study Data Tabulation Model

SDTMIG

SDTM Implementation Guide (for Human Clinical Trials)

SDTMIG-MD

STMIG for Medical Devices

Subject

A participant in a study

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