Work Product for Review

Public Comment on QIBA Profiles and Protocols

All QIBA technical documents (Profiles, Protocols) are posted for Public Comment to ensure stakeholder representation, transparency and quality review. All documents are posted via the QIBA WIKI and announced to a broad e-mail distribution list. QIBA documents are posted for public review for a minimum of 30 days before being considered finalized for trial implementation.

The Public Comment Phase of the development of each QIBA Profile/Protocol allows interested people to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. In particular, vendors who will implement the Profiles/Protocols and members of the healthcare community who will use the Profiles/Protocols are encouraged to review and comment.

• Review the documents listed in the Public Comment WIKI page
• Note the deadline listed next to each document
• Submit your comments via the comment form or direct e-mail to (Susan Weinmann)

The QIBA Biomarker Committees who develop QIBA Profiles and Protocols will consider all comments submitted in the specified public comment period, and where appropriate, respond to comments. Please see below for more detailed instructions for submitting comments.

Directions for Comment Submission

Use the Public Comment Form to submit comments concerning QIBA Profiles/Protocols to the QIBA Biomarker Committees. Documents currently in the Public Comment phase are listed below. Submitted comments will be considered for the revised versions of these documents.

• Please insert your comments on specific Profile/Protocol content into the downloadable Public Comment Form and send by e-mail attachment to (Susan Weinmann)

• If you have general comments about the Profile/Protocol concept, structure, process, etc., please e-mail those directly to (Susan Weinmann)

Instructions:

1. Select and download Profiles or Protocols for review (see link below).

• Profile:
• Protocol:

2. Designate Section or Line Number for each comment (or designate as "general").

3. Specify the Issue concisely and provide any new or replacement text in the Proposal section.

4. Designate the Priority of each comment as High (H), Medium (M), or Low (L)

• H: Important issue where there is a major issue to be resolved; requires discussion and debate.
• M: Medium issue or clarification. Requires discussion, but should not lead to long debate.
• L: Typo or other minor classification that an editor can manage; requires no group discussion.

5. After completing form, save it and send as an e-mail attachment to (Susan Weinmann)

6. Comments are due by date listed next to each document.

QIBA Profiles and Protocols for Reference

• QIBA Profile: QIBA Profile: Quantifying Dopamine Transporters with 123 - Iodine Labeled Ioflupane in Neurodegenerative Disease Profile (v1.0), November 1, 2016 The Public Comment period ends February 1, 2017.

• QIBA Profile: QIBA Profile: Lung Nodule Volume Assessment and Monitoring in Low Dose CT Screening, June 1, 2016 The Public Comment period has closed

• QIBA Spreadsheet: Small Nodule Profile References_Accuracy. Version for Public Comment. June 1, 2016 The Public Comment period has closed

• QIBA Spreadsheet: Small Nodule Profile References_Precision. Version for Public Comment. June 1, 2016 The Public Comment period has closed

• Document Archive