CDISC -ADaM

ADaM : Analysis data model
Fundamentals of the ADaM Standard
Standard ADaM Variables
1
ADaM Variable Conventions
2
General Variable Conventions
3
Timing Variable Conventions
4
Date and Time Imputation Flag Variables
5
Flag Variable Conventions
6
Variable Naming Fragments
The ADaM Subject-Level Analysis Dataset (ADSL)
1
ADSL Identifier Variables
2
Subject Demographics Variables
3
ADSL Population Indicator Variables
4
ADSL Treatment Variables
5
ADSL Dose Variables
6
Treatment Timing Variables
7
Subject-Level Period, Subperiod, and Phase Timing Variables
8
ADSL Subject-Level Trial Experience Variables
9
More concepts on Extra variables
The ADaM (OCCDS)
1
Working with ADAE Conversions with additional variables
2
Working with ADDS Conversions with additional variables
3
Working with ADCM Conversions with additional variables
4
Working with ADEX Conversions with additional variables
The ADaM Basic Data Structure (BDS)
1
1.Identifier Variables for BDS Datasets
2
2. Record-Level Treatment and Dose Variables for BDS Datasets
3
Record-Level Dose Variables for BDS Datasets
4
Timing Variables for BDS Datasets
5
Period, Subperiod, and Phase Start and End Timing Variables
6
Suffixes for User-Defined Timing Variables in BDS Datasets
7
Analysis Parameter Variables for BDS Datasets
8
PARAM, AVAL, and AVALC
9
Analysis Parameter Criteria Variables for BDS Datasets
10
Analysis Descriptor Variables for BDS Datasets
11
Analysis Visit Windowing Variables for BDS Datasets
12
Time-to-Event Variables for BDS Datasets
13
Toxicity and Range Variables for BDS Datasets
14
Flag Variables for BDS Datasets
15
BDS Population Indicators
16
Datapoint Traceability Variables
17
SDTM and ADaM Population and Baseline Flags diference
18
Creation of Derived Columns versus Creation of Derived Rows
19
Rules for the Creation of Rows and Columns
Working with BDS Conversion specs
1
Working with ADVS Conversion with additional Variables
2
Working with ADLB Conversion with additional variables
3
Working with ADTTE Conversion with additional Variables
Business Logics
1
A parameter-invariant function of AVAL and BASE on the same row that does not involve a transform of BASE should be added as a new column.
2
Creation of a New Parameter to Handle a Transformation
3
Creation of a New Parameter to Handle a Second System of Units
4
Creation of a New Row to Handle a Derived Analysis Timepoint
5
Creation of New Rows to Handle a Derived Analysis Timepoint When There is Value-Level Population Flagging
6
Creation of New Rows to Handle Imputation of Missing Values by Last Observation Carried Forward and Worst Observation Carried Forward
7
Creation of New Rows to Handle Imputation of Missing Values by Baseline Observation Carried Forward and Last Observation Carried Forward
8
Creation of Endpoint Rows to Facilitate Analysis of a Crossover Design
ADaM Methodology and Examples When the Criterion Has Multiple Responses
1
ADaM Dataset with a Criterion that Has Multiple Responses
Extra Topics
1
Paired lab variables
2
Lab visit window techniques
3
Raw/Standard Names/Units
4
ADaM – DTYPE
5
ADAM Metadata Excel file
6
ISO8601 Dates, Partial Dates, Durations and Periods
7
Study Validation Checklists
8
Baseline Values
9
Change, Percent Change from Baseline
10
Imputation Methods
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