COURSE CONTENT
CDISC(SDTM/ADaM)
FUNDAMENTALS OF THE SDTM
OBSERVATIONS AND VARIABLES
DATASETS AND DOMAINS
SPECIAL-PURPOSE DATASETS
THE GENERAL OBSERVATION CLASSES
THE SDTM STANDARD DOMAIN MODELS
CREATING A NEW DOMAIN
MODELS FOR SPECIAL-PURPOSE DOMAINS
DEMOGRAPHICS
Demographics — DM
Assumptions for Demographics Domain Model
Examples for Demographics Domain Model
COMMENTS
Comments — CO
Assumptions for Comments Domain Model
Examples for Comments Domain Model
SUBJECT ELEMENTS AND VISITS
Subject Elements — SE
Assumptions for Subject Elements Domain Model
Examples for Subject Elements Domain Model
Subject Visits — SV
Assumptions for Subject Visits Domain Model
Examples for Subject Visits Domain Model
DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES
INTERVENTIONS
Concomitant Medications — CM
Assumptions for Concomitant Medications Domain Model
Examples for Concomitant Medications Domain Model
Exposure — EX
Assumptions for Exposure Domain Model
Examples for Exposure Domain Model
Substance Use — SU
Assumptions for Substance Use Domain Model
Example for Substance Use Domain Model
EVENTS
Adverse Events — AE
Assumptions for Adverse Event Domain Model
Examples for Adverse Events Domain Model
Disposition — DS
Assumptions for Disposition Domain Model
Examples for Disposition Domain Model
Medical History — MH
Assumptions for Medical History Domain Model
Examples for Medical History Domain Model
Protocol Deviations — DV
Assumptions for Protocol Deviations Domain Model
Examples for Protocol Deviations Domain Model
Clinical Events — CE
Assumptions for Clinical Events Domain Model
Examples for Clinical Events Domain Model
FINDINGS
ECG Test Results — EG
Assumptions for ECG Test Results Domain Model
Examples for ECG Test Results Domain Model
Inclusion/Exclusion Criteria Not Met — IE
Assumptions for Inclusion/Exclusion Criteria Not Met Domain Model
Examples for Inclusion/Exclusion Not Met Domain Model
Laboratory Test Results — LB
Assumptions for Laboratory Test Results Domain Model
Examples for Laboratory Test Results Domain Model
Physical Examination — PE
Assumptions for Physical Examination Domain Model
Examples for Physical Examination Domain Model
Questionnaire — QS
Assumptions for Questionnaire Domain Model
Examples for Questionnaire Domain Model
Vital Signs — VS
Assumptions for Vital Signs Domain Model
Example for Vital Signs Domain Model
Drug Accountability — DA
Assumptions for Drug Accountability Domain Model
Examples for Drug Accountability Domain Model
Pharmacokinetics Domains — PC and PP
Assumptions for Pharmacokinetic Concentrations (PC) Domain Model
Examples for Pharmacokinetic Concentrations (PC) Domain Model
Assumptions for Pharmacokinetic Parameters (PP) Domain Model
Example for Pharmacokinetic Parameters (PP) Domain Model
FINDINGS ABOUT
Findings About (FA) Domain Model
Assumptions for Findings About Domain Model
Findings About Examples
TRIAL DESIGN DATASETS
Trial Arms Dataset — TA
Assumptions for TA Dataset
Trial Arms Examples
Trial Elements Dataset — TE
Assumptions for TE Dataset
Trial Elements Examples
Trial Visits Dataset — TV
Assumptions for TV Dataset
Trial Visits Examples
Trial Inclusion/Exclusion Criteria Dataset — TI
Assumptions for TI Dataset
Examples for Trial Inclusion/Exclusion Dataset Model
Trial Summary Dataset — TS
Assumptions for Trial Summary Dataset Model
Examples for Trial Summary Dataset Model
ADaM (Analysis datasets)
Types of analysis datasets
Creating analysis datasets
6)Tables, Lisitings, Graphs(TLFs/TLGs)