caBIG Overview

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caBIG Workspace Prioritization Activity Clinical
Trial Management
Washington, D.C. February 19 20
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Contents

• Goals of this Session
• Workspace Focus
• Workspace Prioritization Activities
• Workspace Prioritization Matrix

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Workspace Prioritization Session - Goals

• Prioritization refers to, in general, the
  development of high-level functional
  requirements, scoping and sequencing of
  activities for each workspace.
• While broad requirements and needs areas have
  already been identified for each workspace, this
  exercise will provide a greater level of detail
  to ensure integration within the workspace,
  according to an agreed upon schedule.
• Prioritization activities will have a slightly
  different focus for each workspace due to the
  differing focus of the workspaces themselves.

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Workspace Focus

• The focus of the Clinical Trial Management
  Workspace is
• Develop a set of caBIG compliant tools to support
  design, management, data capture, and analysis of
  clinical trials
• These tools and capabilities should be easily
  integrated with a variety of existing clinical
  trial data management systems
• Promote adoption of tools and capabilities
  throughout the community both existing tools and
  those developed under this initiative

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Workspace Prioritization Activities

• Review broad functional areas that are critical
  to managing clinical trials (e.g., protocol
  authoring, adverse event reports, electronic
  submission of INDs, etc.) as identified during
  the CDMs.
• Identify high-level functional requirements for
  each functional area. There should be no more
  than 5-10 requirements per functional area. A
  detailed requirements analysis would be a logical
  follow-on to this activity.
• Identify what caBIG interoperability would be
  necessary for each of the functional areas. This
  could include clinical data management platforms,
  vocabulary ontology integration, etc.
• Align adopters and their associated clinical data
  management platforms to pilot tools and
  functional areas. (For example, various adopters
  may have better data sets for piloting adopting
  tools for certain functional areas than for
  others.) We should identify which adopter(s) are
  a good fit for adopting tools in a particular
  functional area.
• Sequence the development of functional areas in
  order of need or dependency. Identify which
  functional areas represent the most critical need
  to the research community or are dependent on
  other functional areas being developed first.

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Workspace Prioritization Matrix