ADaM standard 1 FDA PHuSE ADaM Kick off Meeting 2 Location in the CDISC Standards 3 Clinical trial data and information flow See example of HERA analysis plan Analysis Datasets and ID: 201473
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Slide1
Quick tour of CDISC’s ADaM standard
1Slide2
FDA/PHuSE ADaM Kick off Meeting
2Slide3
Location in the CDISC Standards
3Slide4
Clinical trial data and information flow
See example of HERA
analysis
planSlide5
Analysis Datasets and Tables, Listings, Graphs (TLGs)
VAD Module
Reporting module
In:
SDTMv
data sets
Out: Analysis
data
In: Analysis data sets
Out: Standard
TLGs
SDTM
ADaM
TLGs
process
process
Analysis Datasets sometimes called VADs Value Added DatasetsSlide6
Differences between SDTM and ADaM
SDTM
Designed to store trial data as collected
No redundancy
Designed for data transfer and Interoperability
Few derived variables
Standard domains for each type of subject areaPredominantly character variablesDates are ISO8601 character strings
ADaM
Designed for communication of
scientific results of the trial
Contains collected and derived data as per analysis plan
May use variables from multiple SDTM domains and other
ADaM
datasetsRedundancy is needed for easy analysis and may contain variables for supportive purposesNumeric variables are often needed for analysisDates are numeric to allow calculationHeavily reliant on descriptive metadata
6Slide7
Going from SDTM to ADaM example of “composite endpoint”
7Slide8
ADaM is designed to standardise the way that analysis results are stored and thus presented to authorities.
It is predominantly designed for statistical analyses to reduce and eliminate any processing required by the reviewer.
8Slide9
Where is it described:Core ADaM Standard Documents
www.cdisc.org/adam
Analysis Data Model v2.1
Analysis Data Model Implementation Guide v1.0
Analysis Data Model Data Structure for Adverse Event Analysis v1.0
The
ADaM Basic Data Structure (BDS) for Time-to-Event Analyses v1.0
ADaM
Examples Final
ADaM
Validation Checks v1.2
……..Plus Appendix references
9Slide10
ADaM Dataset Classes
ADSL
(
S
ubject
L
evel Analysis Data)
one
record per
subject
t
he only required dataset in a CDISC-based submission
a
llows simple merging with other datasetsBDS (Basic Data Structure) – one or more records per subject, per analysis parameter per analysis timepoint
(Also used for time to event analyses and LABs.ADAE (Adverse Events) one row per subject per adverse event recordedOther future planned additional datasets : eg General Occurrences: Medications, Medical History.10Slide11
ADSL & BDSGo to implementation guide for list of variables.
11Slide12
BDS example
12Slide13
ADaM RA VADSlide14
ADaM “Metadata” as described in the docs is:
Analysis Dataset Metadata – description of dataset
Analysis Variable Metadata (dataset structures)
Analysis Parameter Value-Level Metadata – specs/derivations used to create analysis values (
paramcds
)
Analysis Results Metadata – derivations and statistical procedures used for a report.14Slide15
ADaM MetadataAnalysis Dataset Metadata
Dataset name (e.g. ADEFF)
Dataset Description (e.g. Primary Efficacy analysis dataset)
Location –
filepath
where the dataset is stored
Structure (e.g. one observation per subject per visit)Class (e.g. “ADSL” , “BDS” or OTHER)Key variables (e.g. USUBJID, AVISIT, PARAMCD)Documentation (e.g. Descriptions of source data, processing steps or references to external documents like Protocol, DAP)These can be included as separate files and hyperlinked
15Slide16
ADaM MetadataAnalysis Dataset Metadata
16Slide17
ADaM MetadataAnalysis Variable Metadata
Variable Name and Dataset Name
Label
Type
Codelist /Controlled terminology
Source or derivation
Core (Req Cond Perm)CDISC Notes17Slide18
ADaM MetadataAnalysis Variable Metadata
18Slide19
ADaM MetadataAnalysis Parameter-Value Level Metadata
Part of Analysis Variable Metadata for VADs with BDS structure
Parameter Identifier for different values of PARAM/PARAMCD contains specifications for how the parameters are derived.
19Slide20
Example of metadata for param codes – value level metadata
20Slide21
Descriptive metadata representation…
…………The
display presentation of the metadata should be determined between the sponsor and the recipient. The example is only intended to illustrate content and not appearance.
21Slide22
ADaM MetadataAnalysis Results Metadata
Allows
reviewers to link from an analysis result to important information describing the analysis such as the reason for performing the analysis, and the dataset and selection criteria used to generate the
analysis
These metadata provide traceability from a result used in a statistical display to the data in the analysis datasets.
Analysis results metadata are not required. However, best practice is that they be provided to assist the reviewer by identifying the critical analyses, providing links between results, documentation, and datasets, and documenting the analyses performed
. 22Slide23
ADaM MetadataAnalysis Results Metadata
23Slide24
Validation Checks
24Slide25
Special AE dataset structure
25Slide26
Summary of ADaM contents
ADSL dataset structure
BDS dataset structure (with BDS TTE and Lab section)
ADAE dataset structure
Descriptive metadata – for datasets, parameters (value level metadata) and results (Table, Listings, Graphs (TLG)) metadata.
Validation
checksDo we have to bear in mind direct links between SDTM model and ADaM model (eg ADSL, ADAE)………………scoping discussion
26