Committee Organization

Organizational Structure

• Steering Committee is established by RSNA
• Executive Committee is established by and reports to the Steering Committee
• Modality Coordinating Committees are established by and report to the Steering Committee
• Biomarker Committees are proposed by the Modality Coordinating Committee and approved by the Steering Committee
  • Biomarker Committees report to their Modality Coordinating Committee
  • Task Forces may be established by and report to a Biomarker Committee, if useful, to:
    • Plan and carry out specific groundwork projects
    • Draft text for review by the Biomarker Committee
  • Task Forces are typically volunteer subsets of their parent Biomarker Committee
• Process Committee is established by and reports to the Steering Committee

See below for the functions and responsibilities of each committee.

Committee Membership

• Rosters for each Committee are posted on the Wiki.
• Steering Committee members are appointed by the RSNA.
• Executive Committee members are:
  • All (three) Co-chairs of the Steering Committee
  • A Representative from each Modality Coordinating Committee
  • A Representative of the Process Committee
  • A Representative of the Sustainability Implementation Group
  • A Representative of the Metrology Committee
  • The External Relations Liaison
  • The NCI/QIB Liaison
  • A Representative of the Secretariat

It is expected that the representative from subordinate committees will be one of the co-chairs of those committees, but the co-chairs may choose to designate other members of their committee as a primary or alternate representative.

Members of the Steering Committee who are not members of the Executive Committee are welcome to join EC meetings as guests.

• Modality Coordinating Committee members are:
  • A Chair, Co-Chair (if applicable), and Vice Chair, all appointed by QIBA/RSNA Leadership
  • The Co-chairs of each Biomarker Committee
  • A Representative of the Metrology Committee
  • A Modality Scientific Liaison
  • Additional voting members (up to a maximum committee size of 15 voting members) recommended by the Biomarker Committees and approved by the Chair, Co-chair, and Vice chair of the Coordinating Committee
  • Additional non-voting members (self-nominated or recommended) appointed by the Coordinating Committee to address potential new biomarkers or to provide specific expertise, e.g., clinical, technical, conformance, vendor representation, etc.
• Biomarker & Process Committees are "open" committees
  • "Open" committees are open to anyone with a relevant interest.
  • Committee Co-Chairs can direct RSNA staff to add names to the roster.

Committee Functions

• Steering Committee
  • Responsible for managing the strategic direction, processes and infrastructure for QIBA and overall oversight of the QIBA activities and committees. This includes:
    • Manage Relationships and Optimize Communications
      • Create a collaborative, multidisciplinary environment that fosters communication among imaging groups and other medical disciplines involved in the research, approval, and use of quantitative imaging biomarkers (QIBs)
      • Educate stakeholders about Profiles
      • Provide content and administrative support of web sites/ Wikis
      • Support face-to-face meetings
    • Coordinate Quantitative Imaging Biomarker Evaluation
      • Evaluate clinical needs for biomarkers for each therapeutic area.
      • Develop and maintain public infrastructure for biomarker-specific data and associated metadata.
      • Oversee inputs and works-in-progress of teams; maintain scorecard.
    • Influence Regulatory Pathways
      • Clarify and optimize pathway for imaging biomarkers to become widely available.
      • Develop process guidance with regulatory agencies inclusive of drug development and patient care.
      • Plan and hold workshops with FDA.
    • Explore Self-funded Models to Maintain Forward Progress
      • Define what size and scope of effort is sustainable and over what period of time.

• Executive Commmittee
  • Authorised by the Steering Committee to handle administrative matters, oversee QIBA activities and make decisions on behalf of the Steering Committee
  • The intention is to streamline business and reduce the meeting load of the full Steering Committee
  • Functions include:
    • Address administrative matters such as:
      • Approval of SC minutes, Review of reports from Coordinating Committees, Review of reports from affiliated organizations
    • Develop proposals, summaries, or recommendations for issues on the Steering Committee agenda to facilitate efficient resolution
    • Make decisions on issues the Executive Committee deems straightforward or needing a timely response
    • Defer matters judged to be of greater complexity or requiring broader discussion to the Steering Committee
    • Fulfill other responsibilities specifically delegated by the Steering Committee.
    • Circulate minutes of each Executive Committee meeting to members of the Steering Committee after each EC meeting
      • Although it is expected that the Steering Committee will not typically spend time reviewing or ratifying Executive Committee decisions, Steering Committee members will be permitted to raise for discussion any business from the Executive Committee, and the Steering Committee has the right to revise, expand, or revoke decisions of the Executive Committee.

• Process Commmittee
  • Responsible for defining processes and tools to promote consistent quality work product by the QIBA Committees and Task Forces.
  • Functions include:
    • Develop ways of working, organizing, etc. across the various entities.
    • Utilize principles from imaging science to understand clinical image information content and utility.
    • Adopt a statistically rigorous framework for determining and reducing sources of variation.
    • Lay out a process for certification of compliance to the Profile and how this relates to regulatory pathways.

• Modality Coordinating Committees
  • Responsible for coordinating Biomarker Committees within their modality. (Most of the Profile work is delegated to Biomarker Committees)
  • Functions include
    • Maintain a balance of work and resources .
    • Identify synergies where possible in groundwork, authoring and testing.
    • Prioritize funding proposals submitted to the Steering Committee
    • Propose established biomarkers that are ready for industrialization to the Steering Committee
    • Participate in the Process Committee and disseminate to the Biomarker Committees and Task Forces in their modality
      • assign a liaison to the Process Committee; the Scientific Liaison might also fill this role
      • help communicate processes and recommendations and monitor adoption
    • Based on the clinical context and needs, identify and prioritize biomarkers to pursue ("work item selection").
      • Propose
      • Evaluate
      • Approve

• Biomarker Committees
  • Responsible for drafting Profiles and protocols, and coordinating associated groundwork and field testing.
  • Functions for each selected biomarker include:
    • Profile development
      • Production
      • UPICT protocol
      • Provisional goals
      • Draft and Review text
      • Collect and Resolve Public Comment
    • Real world validation ("Field-testing")
      • Approve
      • Trial implementation
      • Collect and Resolve feedback
    • Publication
      • Prepare
      • Approve
      • Publish
  • Reference Object(s) and Support Material(s) for Experimentation and Quality Control (QC)
    • Phantoms traceable to recognized physical standards
    • Digital Reference Objects (DRO)
    • Definition of comprehensive QC program, including data analysis and reporting requirements
  • Identification of Technical Characteristics and Standards
    • Assess intrinsic scanner variablity, minimum detectable change, and limits of quantification.
    • Identification and assessment of intra- and inter-reader bias and variance across scanners and centers.
  • Clinical Performance Groundwork
    • Develop a process map detailing steps to meet regulatory and payer requirements.
    • Perform studies necessary if literature does not fully support the process map. These may be retrospective or prospective (e.g.,assessment of intra- and inter-reader sensitivity and specificity for specific clinical utility).
  • Clinical Efficacy Groundwork
    • Characterize value in clinical trials
    • Characterize value in clinical practice
    • Compare new biomarker and 'accepted-as-standard' method
    • Develop/ merge databases from trials in support of achieving statistical power
  • FDA Qualification
    • Request letter
    • Briefing document(s)
    • Full data package
  • Device Compliance
    • Determine compliance testing methods
      • Acquisition
      • Post-processing
    • Device version tracking

See Also

• QIBA Committees
• Committee Procedures
• Voting Privileges
• Process