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    Quick Tour of Cdisc Adam FDA Phuse

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    Kesava Sumanth A
    CDISC's ADaM standard provides standardized structures for organizing clinical trial data for analysis. The key datasets include: 1. ADSL contains one record per subject for simple merging with other datasets. 2. BDS contains one or more records per subject per analysis parameter per timepoint. It is used for time-to-event and laboratory analyses. 3. ADAE contains one row per subject per adverse event. ADaM also includes descriptive metadata for datasets, variables, parameters and analysis results to document transformations and link analyses to source data. Validation checks are specified to validate the analysis datasets meet the standard.

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    Quick Tour of Cdisc Adam FDA Phuse

    Uploaded by

    Kesava Sumanth A
    154 views26 pages
    CDISC's ADaM standard provides standardized structures for organizing clinical trial data for analysis. The key datasets include: 1. ADSL contains one record per subject for simple merging with other datasets. 2. BDS contains one or more records per subject per analysis parameter per timepoint. It is used for time-to-event and laboratory analyses. 3. ADAE contains one row per subject per adverse event. ADaM also includes descriptive metadata for datasets, variables, parameters and analysis results to document transformations and link analyses to source data. Validation checks are specified to validate the analysis datasets meet the standard.

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    CDISC's ADaM standard provides standardized structures for organizing clinical trial data for analysis. The key datasets include: 1. ADSL contains one record per subject for simple merging with other datasets. 2. BDS contains one or more records per subject per analysis parameter per timepoint. It is used for time-to-event and laboratory analyses. 3. ADAE contains one row per subject per adverse event. ADaM also includes descriptive metadata for datasets, variables, parameters and analysis results to document transformations and link analyses to source data. Validation checks are specified to validate the analysis datasets meet the standard.

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    154 views26 pages

    Quick Tour of Cdisc Adam FDA Phuse

    Uploaded by

    Kesava Sumanth A
    CDISC's ADaM standard provides standardized structures for organizing clinical trial data for analysis. The key datasets include: 1. ADSL contains one record per subject for simple merging with other datasets. 2. BDS contains one or more records per subject per analysis parameter per timepoint. It is used for time-to-event and laboratory analyses. 3. ADAE contains one row per subject per adverse event. ADaM also includes descriptive metadata for datasets, variables, parameters and analysis results to document transformations and link analyses to source data. Validation checks are specified to validate the analysis datasets meet the standard.

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    You are on page 1of 26

    Quick tour of CDISCs 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 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
    ADaM
    SDTM
    Designed for communication of
    Designed to store trial data scientific results of the trial
    as collected Contains collected and derived
    No redundancy data as per analysis plan
    May use variables from multiple
    Designed for data transfer SDTM domains and other ADaM
    and Interoperability datasets
    Few derived variables Redundancy is needed for easy
    Standard domains for each analysis and may contain
    variables for supportive
    type of subject area
    purposes
    Predominantly character
    variables Numeric variables are often
    needed for analysis
    Dates are ISO8601 character
    strings Dates are numeric to allow
    calculation
    Heavily reliant on descriptive
    6 metadata
    Going from SDTM to ADaM example of
    composite endpoint

    7
    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.

    8
    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

    9
    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.

    10
    ADSL & BDS

    Go to implementation guide for list of variables.

    11
    BDS example

    12
    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.

    14
    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

    15
    ADaM Metadata
    Analysis Dataset Metadata

    16
    ADaM Metadata
    Analysis Variable Metadata

    Variable Name and Dataset Name


    Label
    Type
    Codelist /Controlled terminology
    Source or derivation
    Core (Req Cond Perm)
    CDISC Notes

    17
    ADaM Metadata
    Analysis Variable Metadata

    18
    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.

    19
    Example of metadata for param codes
    value level metadata

    20
    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.

    21
    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.

    22
    ADaM Metadata
    Analysis Results Metadata

    23
    Validation Checks

    24
    Special AE dataset structure

    25
    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

    26

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