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  1. ADaM Home on the CDISC Portal (Warning - the portal is being removed and documents are being transferred to the wiki)
  2. ADaM Home on the CDISC Wiki (Access may be restricted to ADaM Team Members)


Leadership Team (ALT)

  • Tatiana Sotingco - Current Lead
  • Sandra Minjoe - Former Lead
  • Brian Harris - Future Lead

Leadership Mentors

Nate Freimark - Lead

  • Deborah Bauer
Chris Holland
  • Susan Kenny
  • Nate Freimark
  • Jack Shostak
  • John Troxell

Education - Jack Shostak

Metadata - Monika Kawohl

Compliance - Shelley Dunn

Occurrences - Sandra Minjoe

Multiple Endpoints - TBD

Integration - Deborah Bauer

  • Steve Wilson



Team Mission

To provide metadata models and examples of analysis datasets used to generate the statistical results for a regulatory submission
as well as metadata models and examples covering the statistical results
and other analysis needs.

Scope

The ADaM Team develops standards for the submission of analysis datasets that support the creation of statistical summaries for clinical trials.

  The

 The Analysis Data Model (ADaM) assumes that analysis datasets are created primarily from source data compliant with the Study Data Tabulation Model (SDTM).

 

The ADaM is described by

two

three primary documents:  the Analysis Data Model (Model Document)

and

, its Implementation Guide (ADaMIG)

, as well as supportive appendix documents ADAE, ADTTE, and ODS.    ADaM metadata are modeled the same way as SDTM metadata, except that there is increased emphasis on value-level metadata, and there is a unique kind of metadata known as Analysis Results Metadata.  Throughout the ADaM

, and the Occurrence Data Structure (OCCDS) document. There are other supportive documents such as ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses and Analysis Results Metadata (ARM). 

Throughout the ADaM documents, it is acknowledged that clinical trials are unique, and that the design of analysis datasets is driven by the scientific and medical objectives of the study.

  Clear

 Clear communication regarding the analyses which support these objectives is a foundational principle.

 

The ADaM team

intends to continue

continues to support and enhance

the Model Document and ADaM-IG and to support

our documents, supports the data standardization needs from

the FDA and the Therapeutic

regulatory agencies and therapeutic-area focused initiatives

(e.g., C-PATH, NIH, DCRI)

.  

2014 Goals

The ADaM team will focus full-team and sub-team attention on the following:

  • Document on the introduction of ADaM methodologies to support ISS/ISE and an integrated ADSL structure
  • Explore integrating ADaM in SHARE
  • Development of CFAST/Therapeutic Area ADaM standards
  • Development of ADaM examples and best practices for questionnaire data which can be applied across TA standards
  • Update Compliance rules for consistency with the current version of ADaM-IG
  • Harmonize ADaM model document with Define 2.0 and better address representation of results-level metadata
  • Continued work on ADaM-IG updates
    • Publication of final versions of ODS v1 and ADaMIG v1.1




    Stakeholders/Constituency

    • Regulatory Authorities
    • Standards Development Organizations
    • Pharmaceutical SponsorsMedical Devices, Diagnostics, Biologic, Medical Device, and Diagnostic Sponsors
    • Contract Research Organizations &
    • Consultants

    Collaborations

    The ADaM Team works closely with other CDISC Teams, who utilize or leverage the ADaM standard to develop their own IG, including:

    • SDS (SDTM)
    • , Devices,
    • Define-XML
    • SHARE
    • The ADaM Team also has ties to BRIDG, SHARE, and TA Project Teams

    The ADaM team also participates in PhUSE initiatives

    Operating Model & Meetings

    • Full team meets every other week on Thursday 12Monday 1:3000-2:00 East Coast 30 pm US Pacific time
    • Sub-teams set own meeting schedule, and progress on  full team calls
    • Sub-team leads meet monthly as needed
    • ALT + Mentors meet ALT (ADaM leadership team) meets weekly as needed