How to Write a Profile

Congratulations, you are an author, editor or contributor to a new QIBA Profile. This is much like being a parent (including the "terrible 2's" and those rambunctious teenage years), challenging but rewarding. Also, it does indeed "take a village" to raise a new Profile. A diverse body of expertise

• Review the QIBA Profile Template

This should provide a sense of the content you will be developing. Don't skip the Executive Summary, which highlights the structure, and pay attention to the Guidance comment boxes, which describe some of the issues and considerations you should start thinking about.

• Review the Claim Guidance

The Biomarker Performance Claim is the anchor of the Profile. The remainder of the profile is the Requirements necessary to achieve the claim, and the Assessment Procedures necessary to test the requirements.

As you will see in the Claim Guidance, coming up with good Claim(s) is not trivial. Expect it to be an iterative process as your experience doing the groundwork and drafting the profile gives you a better appreciation.

<to be continued>