Difference between revisions of "Committee Procedures"

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==Organizational Structure==
 
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* '''Steering Committee''' is established by RSNA
 
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** Responsible for managing the strategic direction, processes and inftrastructure for QIBA and overall oversight of the QIBA activities and committees.
 
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* '''Modality Coordinating Committees''' are established by the Steering Committee
 
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** Responsible for coordinating Biomarker Committees within their modality.
 
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* '''Biomarker Committees''' are proposed by the Modality Coordinating Committee and approved by the Steering Committee
 
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** Responsible for drafting Profiles and protocols, and coordinating associated groundwork and field testing.
 
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** '''Task Forces''' are established by the Biomarker Committee as needed to:
 
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*** Plan and carry out specific groundwork projects.
 
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*** Write Profiles and/or protocols.
 
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* '''Process Committee''' is established by the Steering Committee
 
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** Responsible for defining processes and tools to promote consistent quality work product by the QIBA Committees and Task Forces.
 
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* '''QIDW Oversight Committee''' is established by the Steering Committee
 
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** Responsible for managing the establishment and effective operations of the Quantitative Imaging Data Warehouse.
 
  
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==Committee Membership==
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==Meeting Procedures==
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* '''Steering Committee''' members are appointed by the RSNA.
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The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.
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* '''Modality Coordinating 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 Modality 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.
 
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* '''Biomarker Committees''' are "open" committees
 
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** '''"Open" committees''' are open to anyone with a relevant interest.
 
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** '''Committee Co-Chairs''' can direct RSNA staff to add names to the roster.
 
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** '''Task Forces''' are typically volunteer subsets of their parent Biomarker Committee
 
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* '''Rosters''' for each Biomarker Committee are posted on the Wiki.
 
  
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==Decision Making==
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* When participation at a given meeting is not open to all committee members, (e.g. it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee.  No official decisions will be made and attendance will not count toward or against voting privileges.  
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* Goal: group consensus and imaging community input and endorsement on major decisions.
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** Typically, RSNA staff are present at meetings and capturing attendance.  If staff is not present, the chair will need to ensure that attendance records are captured and submitted to RSNA staff.
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* Recorded vote required for procedural decisions
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** If possible, it is still desirable for minutes to be recorded, but the unofficial status will be noted
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** Key group decisions, such as public dissemination of documents, are subject to approval by Modality Committees
 
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** Majority of participating members passes
 
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** Negative votes must be discussed
 
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* For recorded votes:
 
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** Meeting attendee names and vote outcome will be recorded in minutes.
 
  
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A record of committee decisions and rationale is necessary to be effective and learn.
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* ''RSNA Staff'' records minutes (call summaries) for meetings of Committees (but not Task Forces)
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* ''Chairs'' are strongly encouraged to support RSNA Staff by reviewing/correcting the draft minutes circulated by RSNA Staff
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* ''RSNA Staff'' maintains '''[[Committees|rosters of the members of each committee]]''' and their participation.  Those details are used to determine which members currently have '''[[Voting Privileges]]'''
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** ''Members'' who believe their attendance record is in error should contact RSNA Staff
  
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==Committee Functions==
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==Voting==
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Most committee work doesn't need a vote.  At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings.  This also facilitates recording key decisions in the minutes.
  
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*'''Steering Committee:'''
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* ''Chairs'' accept motions, seconds, discussion, and then call for a vote
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**Manage Relationships and Optimize Communications
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** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "RSNA Staff'' notes those names.  The rest of those present with voting privileges can safely be assumed to have voted in favor
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***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)
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* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote
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***Educate stakeholders about Profiles
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* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''
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***Provide content and administrative support of web sites/ Wikis
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** details of the resolution discussion in the minutes is desirable
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***Support face-to-face meetings
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* ''RSNA Staff'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes
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**Determine and Manage Process
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** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by ''RSNA Staff''
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***Develop ways of working, organizing, etc. across the various entities.
 
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***Utilize principles from imaging science to undertand clinical image information content and utility.
 
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***Adopt a statistically rigorous framework for determining and reducing sources of variation.
 
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***Lay out a process for certification of compliance tot he Profile and how this relates to regulatory pathways.
 
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**Coordinate Quantitative Imaging Biomarker Evaluation
 
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***Evaluate clinical needs for biomarkers for each therapeutic area.
 
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***Develop and maintain public infrastructure for biomarker-specific data and associated metadata.
 
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***Oversee inputs and works-in-progress of teams; mantain scorecard.
 
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**Influence Regulatory Pathways
 
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***Clarify and optimize pathway for imaging biomarkers to become widely available.
 
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***Develop process guidance with regulatory agencies inclusive of drug development and patient care.
 
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***Plan and hold workshops with FDA.
 
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**Explore Self-funded Models to Maintain Forward Progress
 
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***Define what size adn scope of offort is sustainable and over what period of time.
 
  
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*'''Modality Committees''' (Most of the this work is delegated to Biomarker Committees)
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==Email Ballot==
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** Coordinate the Biomarker Committees in their modality
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Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.
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*** Maintain a balance of work and resources .
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*** Identifying synergies where possible in groundwork, authoring and testing.
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A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot).  Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.
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*** Prioritizing funding proposals submitted to the Steering Committee
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*** Proposing established biomarkers that are ready for industrialization to the Steering Committee
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* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff
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**Based on the clinical context and needs, identify and prioritize biomarkers to pursue ("work item selection").
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** The ballot period may be specified by the particular procedure that calls for a ballot
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***Propose
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** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote
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***Evaluate
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** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period
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***Approve
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* ''RSNA Staff'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision
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**For each selected biomarker:
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* ''RSNA Staff'' emails a notification of ineligibility to the rest of the members of the committee making the decision
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***Profile development
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** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments
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****Production
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** Members who believe their attendance record is in error can review of their attendance with RSNA Staff and if they are found to be eligible will be sent a ballot
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****UPICT protocol
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* ''RSNA Staff'' compiles the ballot responses and comments for the Chairs
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****Provisional goals
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** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken
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****Draft and Review text
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* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process
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****Collect and Resolve Public Comment
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* ''RSNA Staff'' records resolution results/rationale in the minutes
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***Real world validation ("Field-testing")
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****Approve
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==Quorum==
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****Trial implementation
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For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).
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****Collect and Resolve feedback
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***Publication
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==Consensus Process==
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****Prepare
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As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.
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****Approve
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****Publish
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* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but
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**Reference Object(s) and Support Material(s) for Experimentation and Quality Control (QC)
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** a '''negative vote or votes should result in subsequent discussion''' to
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***Phantoms traceable to recognized physical standards
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*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting
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***Digital Reference Objects (DRO)
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** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:
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***Definition of comprehensive QC program, including data analysis and reporting requirements
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*** misgivings
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**Identification of Technical Characteristics and Standards
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*** not been able to adequately evaluate the question
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***Assess intrinsic scanner variablity, minimum detectable change, and limits of quantification.
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***Identification and assessment of intra- and inter-reader bias and variance across scanners and centers.
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==Committee Leadership==
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**Clinical Performance Groundwork
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* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) 
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***Develop a process map detailing steps to meet regulatory and payer requirements.
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** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually
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***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).
 
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**Clinical Efficacy Groundwork
 
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***Characterize value in clinical trials
 
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***Characterize value in clinical practice
 
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***Compare new biomarker and 'accepted-as-standard' method
 
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***Develop/ merge databases from trials in support of achieving statistical power
 
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**FDA Qualification
 
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***Request letter
 
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***Briefing document(s)
 
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***Full data package
 
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**Device Compliance
 
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***Determine compliance testing methods
 
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****Acquisition
 
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****Post-procesing
 
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***Device version tracking
 
  
 
==See Also==
 
==See Also==
 
* [[Committees|QIBA Committees]]
 
* [[Committees|QIBA Committees]]

Revision as of 16:48, 9 July 2019

Meeting Procedures

The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.

  • When participation at a given meeting is not open to all committee members, (e.g. it takes place at an “invitation-only” face-to-face event and remote access is not provided for the committee meeting), that meeting will not be considered an official meeting of that committee. No official decisions will be made and attendance will not count toward or against voting privileges.
    • Typically, RSNA staff are present at meetings and capturing attendance. If staff is not present, the chair will need to ensure that attendance records are captured and submitted to RSNA staff.
    • If possible, it is still desirable for minutes to be recorded, but the unofficial status will be noted

A record of committee decisions and rationale is necessary to be effective and learn.

  • RSNA Staff records minutes (call summaries) for meetings of Committees (but not Task Forces)
  • Chairs are strongly encouraged to support RSNA Staff by reviewing/correcting the draft minutes circulated by RSNA Staff
  • RSNA Staff maintains rosters of the members of each committee and their participation. Those details are used to determine which members currently have Voting Privileges
    • Members who believe their attendance record is in error should contact RSNA Staff

Voting

Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.

  • Chairs accept motions, seconds, discussion, and then call for a vote
    • At its simplest, the Chair asks for objections, then asks for abstentions, and "RSNA Staff notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor
  • Members who have Voting Privileges count towards quorum and may vote
  • Chairs resolve negative votes and large numbers of abstentions per the consensus process
    • details of the resolution discussion in the minutes is desirable
  • RSNA Staff records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes
    • If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by RSNA Staff

Email Ballot

Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.

A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.

  • Chairs submit the ballot question and length of the ballot period to RSNA Staff
    • The ballot period may be specified by the particular procedure that calls for a ballot
    • The ballot period is generally not less than 14 days to allow adequate time to review the material and vote
    • If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period
  • RSNA Staff emails the ballot to all members with Voting Privileges on the committee making the decision
  • RSNA Staff emails a notification of ineligibility to the rest of the members of the committee making the decision
    • Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments
    • Members who believe their attendance record is in error can review of their attendance with RSNA Staff and if they are found to be eligible will be sent a ballot
  • RSNA Staff compiles the ballot responses and comments for the Chairs
    • o At the discretion of the Chairs, comments submitted by non-voting members may be stricken
  • Chairs ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process
  • RSNA Staff records resolution results/rationale in the minutes

Quorum

For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).

Consensus Process

As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.

  • a vote/ballot passes with a quorum of votes and a majority of votes in favor, but
    • a negative vote or votes should result in subsequent discussion to
      • understand the reason for such (a) negative vote(s) and attempt to find a compromise or resolution; associated edits to the document under ballot do not typically require re-balloting
    • a large number of abstentions may also warrant discussion; it may indicate many people have:
      • misgivings
      • not been able to adequately evaluate the question

Committee Leadership

  • Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.)
    • If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually

See Also

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