HCLS/F2F/DrugSafety

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HCLS Drug Safety&Efficacy DSE main page

  1. Scenario collection and discussion around Clinical Trails (CT) data collection/aggregation and translational analysis
    1. Making SDTM data "Recombinable" across studies (Kerstin Forsberg)
    2. Translational Science Scenario (Bo Andersson)
    3. Scenario...
    4. Scenario...
  2. Relevance and Strategy for mapping CDISC SDTM into RDF-OWL frame
    1. Study Data Tabulation Model (SDTM)
      1. SDTM Model v1.0
      2. Implementation Guide
      3. CDISC Comments and Responses
  3. SDTM elements or functionality to focus on
    1. Multiple Data Tables (Sets) from studies
    2. Genomic and Biomarker data in studies and submissions (trend shown below) HCLS$$F2F$$DrugSafety$nbt0906-1105-F1.gif                                                                                                    http://www.nature.com/nbt/journal/v24/n9/full/nbt0906-1105.html
  1.#3 Controlled vocabularies (URI nodes) used in SDTM obeservational elements
  1. Discussion (around scenarios?) about defining annotation layers around clinical information systems (JANUS?)
    1. Basic Janus model
    2. Necessary Components needed for supporting Translational Research
      1. Biomarker linking (retrospective and follow-up studies)
      2. Mechanism (Pathway) linking: latest knowledge automatically updated
      3. Target knowledge assembly
      4. Comprehensive linking of Toxicity information
  2. Access Control and security
    1. HIPAA/21Part11 issues to be identified