Guidance Document Process

DRAFT

Periodically, it may be useful for the QIBA Community to publish a document that is not a Profile but does provide expert guidance from QIBA on performing imaging in situations where quantitative image quality is needed. <Q. Should QIBA get into general imaging guidance or should that be left to others?>

A QIBA Guidance document does not include a performance claim or formal conformance requirements and is not constrained to the common structure of a QIBA Profile. If fact, it is probably best if Guidance uses different formatting to avoid confusion with QIBA Profiles.

A QIBA Guidance does provide recommendations/best practices related to imaging procedures and associated patient handling, device qualification, etc.

The typical audience of a QIBA Guidance document includes:

• <Q. good list?>

A QIBA Guidance document is developed by Task Force formed by the Steering/Executive Committee. <Q. Should a Modality Coordinating Committee also be able to ? > <Q. Can we add a brief text explaining when/why QIBA would benefit from doing one? We don’t exactly want to encourage anyone who has a paper and wants to up its profile by getting a QIBA Guidance sticker...>

Task Force membership is recommended to include a similar breadth of expertise to a Biomarker Committee, i.e. it would ideally include input from radiologists, physicists, equipment vendors, technologists, <Q…?>

While QIBA Guidance development may benefit from a Public Comment period, it is not required to do so. Similarly, as it is not expected to track and publish comment resolutions. Depending on affiliated organizations with an interest and/or gaps in the Task Force, targeted review may be helpful. <better words>

Before publication, the QIBA Guidance document is approved by the Committee that formed the Task Force. For modality-specific Guidance, the Steering/Executive Committee may request the corresponding Modality Coordinating Committee to do an initial review and make a recommendation to the Steering/Executive Committee. For non-modality-specific Guidance (e.g., trans-modality papers, metrology papers, etc.) the Steering/Executive Committee may convene an ad hoc review group made up of members from relevant QIBA Committees. Typically the Task Force is dissolved when the document has been approved and published and no near term maintenance/updates are expected.

In some circumstances, QIBA Guidance may need to be issued quickly, in which case the Steering/Executive Committee may choose to shorten typical ballot/review periods.

Note: This process is not intended to apply to papers written by any group of expert authors that refer to QIBA or its activities in the text, but are not presented as guidance from QIBA.