PUBLIC COMMENT WORK PAGE

Public Comment on QIBA Profiles

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 Profiles 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 allows interested people to provide input on the Profiles, the scenarios and use cases they address, the technologies proposed and other details. In particular, vendors who will implement the Profiles and members of the healthcare community who will use the Profiles are encouraged to review and comment.

• Review the documents listed in the Profiles WIKI page
• Note the deadline listed under the document link
• Submit your comments via the comment form

The QIBA Biomarker Committees that develop QIBA Profiles will consider 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 form below to submit comments concerning QIBA Profiles to the QIBA Technical Committees. Documents currently in the Public Comment phase are listed below. Submitted comments will be considered for the revised versions of these Profiles.

• Please insert your comments on specific Profile content into the QIBA Public Comment Form

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

Instructions:

1. Review the applicable Profile on the QIBA Wiki Profiles page

2. Designate Profile Title, Section and 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 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. Comments are due by date listed next to each Profile.