Trial Implementation Process-DRAFT PAGE

Solicited Feedback during Field Tests 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.

Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used or are using it.

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

Period: 30 days

1. Collect from Field Leader a list of people who have participated in the field test
2. Technical Committee finalizes comment form (i.e.,standard form linked below, or modified standard form if necessary) that will be used in the survey
3. RSNA announces Call for Feedback to mailing lists, including
   • a. link to the document
   • b. link to the QIBA QIBA Trial Implementation Feedback Template

• 4. Field Test Leader (Commenters) email completed Feedback Form to RSNA
• 5. RSNA collates all Feedback comments into a spreadsheet
• 6. Field Test Leader may additionally summarize feedback into a report
• 7. Technical Committee reviews comments, making changes to the document as needed.
• 8. TC records comment resolutions in spreadsheet.
• 9. TC votes on next step for the document, either:
  • a. refer the document to the Modality Committee for Final Text publication
  • b. conduct another round of field test on revised document
  • c. place the document into inactive status
• 10. RSNA posts comment spreadsheet, revised document to the Wiki.

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. TC finalizes comment form that will be used in the survey.
• 3. RSNA sends announcement to mailing lists.
  • a. reminder copy of document that had been placed into field test
  • b. provide a link to the QIBA User Feedback Form QIBA User Feedback Template
• 4. Commenters email comments to RSNA.
  • a. 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.
  • b. commenters are requested to use the provided comment form.
• 5. RSNA collates all comments into a spreadsheet.
  • a. Summarize range of feedback to the questions into a report for review by the technical committee provided by RSNA Staff.
  • b. 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. TC records resolution in spreadsheet.
  • a. Regardless of recommended status for this document, ensure that the results are made available to related activities.

Trial Protocol/Profile Implementation Feedback Process on the QIBA Wiki:

• Profile: DCE-MRI Quantification Version 1.6 12-13-2011