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 Committees''' are established by the Steering Committee
 
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** Responsible for coordinating modality areas of QIBA, and to formalize (i.e., vote, on) decisions when needed.
 
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* '''Technical Committees''' are established by the Modality Committee
 
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** Responsible for selecting biomarkers, drafting Profiles and protocols, and coordinating groundwork.
 
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** '''Groundwork Committees''' are established by the Technical Committee as needed to carry out specific groundwork projects.
 
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** '''Authoring Groups''' are established by a Technical Committee as needed to write Profiles and/or protocols.
 
  
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==Meeting Procedures==
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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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==Committee Membership==
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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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* '''Steering Committee''' members are appointed by the RSNA.
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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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* '''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.
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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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* '''Technical, Groundwork and Authoring 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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** '''Groundwork Groups''' and '''Authoring Committees''' are typically volunteer subsets of their parent Technical Committee
 
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* '''Rosters''' for each Technical Committee are posted on the Wiki.
 
  
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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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==Decision Making==
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==Voting==
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* Goal: group consensus and imaging community input and endorsement on major decisions.
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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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* Recorded vote required for procedural decisions
 
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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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* ''Chairs'' accept motions, seconds, discussion, and then call for a vote
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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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* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote
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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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** details of the resolution discussion in the minutes is desirable
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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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** 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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==Committee Functions==
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==Email Ballot==
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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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*'''Steering Committee:'''
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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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**Manage Relationships and Optimize Communications
 
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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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***Educate stakeholders about Profiles
 
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***Provide content and administrative support of web sites/ Wikis
 
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***Support face-to-face meetings
 
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**Determine and Manage Process
 
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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 Technical Committees)
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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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****Collectand 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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Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.
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**Clinical Performance Groundwork
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***Develop a process map detailing steps to meet regulatory and payer requirements.
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==Committee Leadership==
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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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* 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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**Clinical Efficacy Groundwork
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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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***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 compliabce 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 21:13, 19 May 2020

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

Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.

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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