Committee Procedures

Organizational Structure

• Steering Committee is established by RSNA
  • Responsible for managing the strategic direction, processes and inftrastructure for QIBA and overall oversight of the QIBA activities and committees.
• Modality Committees are established by the Steering Committee
  • Responsible for coordinating modality areas of QIBA, and to formalize (i.e., vote, on) decisions when needed.
• Technical Committees are established by the Modality Committee
  • Responsible for selecting biomarkers, drafting Profiles and protocols, and coordinating groundwork.
  • Groundwork Committees are established by the Technical Committee as needed to carry out specific groundwork projects.
  • Authoring Groups are established by a Technical Committee as needed to write Profiles and/or protocols.

Committee Membership

• Steering Committee members are appointed by the RSNA.
• Modality Committee members can be self-nominated, but must have participated in at least 50% of teleconferences during the previous 12 months. Retention of modality committee membership will require participation in at least 50% of teleconferences. Participation in teleconferences will be assessed on a rolling basis every 6 months. New members can be added to Modlality Committees every 6 months based on their participation in a tleast 50% of TC calls during the previous 12 months. The minimum level of teleconference participation is established by the Steering Committee and can be changed by the Steering Committee if it sees fit to do so.
• Technical, Groundwork and Authoring 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.
  • Groundwork Groups and Authoring Committees are typically volunteer subsets of their parent Technical Committee
• Rosters for each Technical Committee are posted on the Wiki.

Quorum & Voting Privileges

Participation is open and voluntary, but participants must take part regularly in committee meetings and teleconferences and perform committee assignments.

• Quorum is 50% of committee members with Voting Privileges

Voting Privileges are based on the Roster Role and attendance of the Member for each committee.

• Each Member listed on the Roster with Voting Privileges may cast one vote and counts as one towards quorum.

Option A

• Members are granted Voting Privileges after attending over 50% of the meetings in a 6 month period
• Members lose voting privileges after attending less than 50 of meetings in a past 6 month period
• Voting Privileges are evaluated and updated twice a year by the Secretariat

Option B

• Members are granted Voting Privileges at the start of their second consecutive meeting.
• Members lose voting privileges after missing three consecutive meetings (where a vote is taken)
• Voting Privileges are evaluated and updated every few months or at request of a member.
• An email ballot counts as a meeting.

Decision Making

• Goal: group consensus and imaging community input and endorsement on major decisions.
• Recorded vote required for procedural decisions
  • Key group decisions, such as public dissemination of documents, are subject to approval by Modality Committees
  • Majority of participating members passes
  • Negative votes must be discussed
• For recorded votes:
  • Meeting attendee names and vote outcome will be recorded in minutes.

Committee Functions

• Steering Committee:
  • 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
  • Determine and Manage Process
    • Develop ways of working, organizing, etc. across the various entities.
    • Utilize principles from imaging science to undertand 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 tot he Profile and how this relates to regulatory pathways.
  • 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; mantain 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 adn scope of offort is sustainable and over what period of time.

• Modality Committees (Most of the this work is delegated to Technical Committees)
  • Based on the clinical context and needs, identify and prioritize biomarkers to pursue ("work item selection").
    • Propose
    • Evaluate
    • Approve
  • For each selected biomarker:
    • Profile development
      • Production

See Also

• QIBA Committees