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 Committees 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, pharma, 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 User Feedback Form.
3. Commenters email Implementation 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 votes on next step for the document, either:
   • Refer the document to the Modality Committee for re-publication of an updated version
   • Branch the document leaving the current version in place but spawning a derivative
   • Place the document into inactive status
6. All resolution will be documented and made available on the Wiki.

Solicited Feedback during Field Test of QIBA Documents

The purpose of this step is to actively seek feedback on use of published QIBA documents in a formally organized "Field Test."

A procedure for Field Test feedback is outlined below.

1. RSNA collects from Field Test Leader a list of people who participated in the field test.
2. RSNA announces Call for Feedback to the list of people who participated in the field test. The announcement includes a:
   • Link to the document
   • Link to the QIBA Protocol/Profile User Feedback Form
3. Field Test Leaders and/or Participants email completed User Feedback Form to (Joe Koudelik) at RSNA.
4. RSNA collates all Feedback comments into a spreadsheet.
5. Field Test Leader may additionally summarize feedback into a report.
6. Technical Committee reviews comments, making changes to the document as needed.
7. Technical Committee records comment resolution in spreadsheet.
8. Technical Committee votes on next step for the document, either:
   • Refer the document to the Modality Committee for Final Text publication
   • Conduct another round of field test on revised document
   • Place the document into inactive status
9. RSNA posts comment spreadsheet and revised document to the Wiki.

Current Protocol/Profile Documents:

Note to users - when referencing these QIBA Profile documents, please use the following format:

Specific QIBA Tech Ctte. * Specific Profile Title, * Quantitative Imaging Biomarkers Alliance. * Version. * Profile Stage. * QIBA, * Date.

Format example: DCE-MRI Technical Committee. DCE-MRI Quantification Profile, Quantitative Imaging Biomarkers Alliance. Version 1.0. Reviewed Draft. QIBA, July 1, 2012. Available from: RSNA.ORG/QIBA

• QIBA Profile. DCE-MRI Quantification v1.0 Reviewed Draft (Publicly Reviewed Version)

• QIBA Profile. CT Tumor Volume Change v2.2 Reviewed Draft (Publicly Reviewed Version)

• FDG-PET/CT as an Imaging Biomarker Measuring Response to Cancer Therapy (Publicly Reviewed Version)