QIBA Profile Drafting Process

<<Work In Progress>>

The purpose of the Drafting stage is to capture and reach committee consensus on the requirements that the devices and people covered in the Profile must meet to claim compliance.

During the drafting process, keep in mind the three primary functions of a profile:

• tell sites what can be accomplished by following the Profile. ("Profile Claims")
• tell vendors what they must implement in their product to state compliance with the Profile. ("Profile Details")
• tell user staff what they must do for the Profile Claims to be realized. ("Profile Details")

Normative Content

The second two bullets above are sometimes referred to as the Normative Content of a Profile.

Normative Content is expressed using "shall language" . Specifically, use the word "shall" in every normative requirement. This both makes it clear that something is required, and makes it easy for implementers to search for the word Shall to find requirements. Avoid words like must, has to, needs to, should, could, might, etc.

Make sure it is clear which device or person is responsible for each requirement. For example, avoid the passive voice. "The acquisition modality shall record the

Informative Content

A common secondary function of the profile is to explain to vendors and users things like:

This is referred to as Informative Content.

• Levels of Conformance
  • Conformance is binary; you either do or do not ("there is no try" 05.04).
  • Systems/sites/cases that fail to conform may still be useful, they just cannot rely on achieving the claim.