QIBA Protocol/Profile Implementation Feedback Process

Solicited Feedback during Implementation of QIBA Documents

This step collects feedback on use of the documents by users in the field, including clinical trialists, imaging scientists, pharma, CRO’s, etc.

QIBA Technical Committiees are interested in feedback on how well Protocols and Profiles work in practice. Therefore we solicit comments specifically from those that have used or are using them.

A procedure is outlined below.

1. Periodically, RSNA collects lists of people that may have used the document, and/or professional societies that may have a particular interest in the document. The goal is to include a full range of users of the document, e.g., vendors/suppliers, clinical trialists, imaging scientists, pahrma, CRO's, etc.
2. RSNA sends an announcement to the relevant mailing lists, including a:
   • Link to the document
   • Link to the QIBA Protocol/Profile Implementation Feedback Form.
3. Commenters email a Feedback Form to (Joe Koudelik) at RSNA.
4. RSNA collates all comments into a spreadsheet for review by the Technical Committee.
   • Technical Committee decides what changes to make (if any) to the document and records resolution in a spreadsheet.
5. Technical Committee determines whether to refer the document to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document.

Solicited Feedback after Publication of QIBA Documents

The purpose of this process step is to actively seek and periodically respond to feedback on use of published QIBA documents. It is important to put this into context with other activities that may seem similar at first. Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time, clinical trials that had been designed with the QIBA document may close, and/or other results from field usage may become evident either with the user or supplier base. Therefore, comments are solicited periodically for a wide range of the public that may connect with it in some way.

A procedure is outlined below listing what is done and by whom.

Period: 30 days

1. Periodically, RSNA collects lists of people that may have used the document and/or professional societies that may have a particular relationship to the document.
2. Technical Committee finalizes comment form that will be used in the survey.
3. RSNA sends announcement to mailing lists
   • Reminder copy of document that had been placed into field test
   • Provide a link to the QIBA User Feedback Form
4. Commenters email comments to RSNA at (Joe Koudelik)
   • Include full range of users of the document, e.g., vendors/suppliers, clinical trialists, imaging scientists, pharma, CRO’s, etc. However, only people who have used document are included.
   • Commenters are requested to use the provided comment form.
5. RSNA collates all comments into a spreadsheet.
   • Summarize range of feedback to the questions into a report for review by the Technical Committee provided by the secretariat.
   • Technical Committee decides what changes to make (if any) to the document and whether to refer it to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document.
6. Technical Committee records resolution in spreadsheet.
   • Regardless of recommended status for this document, ensure that the results are made available to related activities.

Protocol/Profile Implementation Feedback Process on the QIBA Wiki:

• QIBA Profile. DCE-MRI Quantification v1.0 Reviewed Draft (Public Comments Addressed)

• QIBA Profile. CT Tumor Volume Change v2.2 Reviewed Draft (Public Comments Addressed)