Quick tour of CDISCs ADaM standard

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FDA/PHuSE ADaM Kick off Meeting

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Location in the
CDISC Standards

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Clinical trial data and information flow

See example of HERA analysis plan

Analysis Datasets and
Tables, Listings, Graphs (TLGs)

VAD Module Reporting

module
In: SDTMv data In: Analysis data
sets sets
Out: Analysis data Out: Standard
TLGs
proce process
SDT ADa TLGs
ss
M M

Analysis Datasets sometimes called VADs Value

Added Datasets
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
6 metadata
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
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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