Quick_Tour_of_CDISC_..

Report
Quick tour of CDISC’s 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
Tables, Listings, Graphs (TLGs)
VAD Module
In:
Out:
SDTM
Reporting module
SDTMv data sets
Analysis data
process
In:
Out:
ADaM
Analysis data sets
Standard TLGs
process
Analysis Datasets sometimes called VADs Value Added
Datasets
TLGs
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 area
•
Predominantly character variables
•
Dates 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
datasets
• Redundancy is needed for easy
analysis and may contain variables
for supportive purposes
• Numeric variables are often needed
for analysis
• Dates are numeric to allow
calculation
• Heavily reliant on descriptive
metadata
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Going from SDTM to ADaM example of
“composite endpoint”
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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.
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Where is it described:
Core ADaM Standard Documents
www.cdisc.org/adam
1. Analysis Data Model v2.1
2. Analysis Data Model Implementation Guide v1.0
3. Analysis Data Model Data Structure for Adverse Event Analysis v1.0
4. The ADaM Basic Data Structure (BDS) for Time-to-Event Analyses
v1.0
5. ADaM Examples Final
6. ADaM Validation Checks v1.2
……..Plus Appendix references
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ADaM Dataset Classes
• ADSL (Subject Level Analysis Data)
– one record per subject
– the only required dataset in a CDISC-based submission
– allows simple merging with other datasets
• BDS (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
recorded
• Other future planned additional datasets : eg General Occurrences:
Medications, Medical History.
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ADSL & BDS
• Go to implementation guide for list of variables.
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BDS example
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ADaM RA VAD
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.
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ADaM Metadata
Analysis 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
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ADaM Metadata
Analysis Dataset Metadata
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ADaM Metadata
Analysis Variable Metadata
• Variable Name and Dataset Name
• Label
• Type
• Codelist /Controlled terminology
• Source or derivation
• Core (Req Cond Perm)
• CDISC Notes
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ADaM Metadata
Analysis Variable Metadata
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ADaM Metadata
Analysis 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.
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Example of metadata for param codes – value
level metadata
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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.
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ADaM Metadata
Analysis 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.
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ADaM Metadata
Analysis Results Metadata
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Validation Checks
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Special AE dataset structure
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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 checks
• Do we have to bear in mind direct links between SDTM model and
ADaM model (eg ADSL, ADAE)
………………scoping discussion
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