CDISC Joint Team Meetings

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CDISC Joint Team Meetings
 
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CDISC Implementation Groups
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Scope of CDISC Models
Operational Data Interchange Archive ODM, LAB
Submission Data Interchange Archive SMM SDS,
ADaM

• Data Sources
• Site CRFs
• Laboratories
• Contract
• Research
• Organizations
• Development
• Partners

• Operational
• Database
• Study Data
• Audit Trail
• Metadata

• Submission
• Data
• CRT/Domain Datasets
• Analysis Datasets
• Metadata

ODM Operational Data Model SDS
Submission Domain Standards LAB Laboratory
Data Model ADaM Analysis
Dataset Models SEND Std. Exch
NonClin Data Protocols Terminology
Sub-Teams Trial design, Define.xml
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CDISC Team Reports

• Submission Data Standards (SDS) Team
• Std. for Exchange of Non-Clinical Data Team
  (SEND)
• Analysis Data Modeling (ADaM) Team
• Operational Data Modeling (ODM) Team
• LAB Data Modeling (LAB) Team
• Terminology Team
• Protocol Team

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SDS Team Mission

• Provide regulatory submission reviewers with
  clear descriptions of the usage, structure,
  contents attributes of all submitted datasets
  and variables
• Define standard data formats to allow reviewers
  to use standard tools
• To replicate most analyses, tables, graphs and
  listings
• To easily view and subset the data used to
  generate any analysis, table, graph or listing
  without complex programming..

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SDS Team Report

• Recent Accomplishments Hurdles
• SDTM and SDTM IG
• Current activities and challenges
• Implementation questions rolling in
• Resolving other critical models (PK, MB, LS)
• Addressing therapeutic areas
• Controlled terminology
• Expanding membership becoming more involved in
  other teams
• Responding to feedback from FDA data review
  committee.
• .

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SDS Team Report

• Membership, meeting structures and key personnel
• About 30 participants from 20 companies
• TC every 2 weeks F2F once per quarter
• Future key milestones 2005 Plans
• SDTM Update (Q1 05)
• SDTM IG Update (Q1 05)
• FDA Public Meeting (Feb. 1, 2005)
• Maintenance update (Q4 2005 Q1 2006)

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SDS Team Report Issues

• Respond to support questions rapidly
• Address new needs (sponsors, SEND, Janus other
  FDA Centers) without disrupting core model
  (backwards compatibility)
• Accommodating new members and participating more
  in other teams
• Facilitating the issuance of controlled
  terminology necessary to the model
• Completing the trial design model in a manner
  that will be accepted by industry.

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CDISC Joint Team Meetings
 
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Team Report Structure

• 10 minutes per team
• Report structure
• Team Mission
• Recent accomplishments, hurdles overcome
• Discuss current activities and challenges
• Review membership, meeting structures and key
  personnel
• Describe future key milestones, 2005 plans
• Identify potential needs, issues and concerns.