Assessment Procedure Guidance

Section 4 of the Profile contains procedures for assessing requirements from Section 3 that cannot be assessed by direct observation or some other simple method.

This material supplements the Profile Template and the Claim Guidance by describing the process of developing appropriate procedures to assess such requirements, particularly those related to the performance assumptions underlying the claim (e.g. the repeatability coefficient for the volumes generated by the tumor segmentation software).

• QIBA Assessment Procedure Guidance December 2016 DRAFT

Suggestions

Submit suggested improvements/gaps by adding bullets here:

They will be reviewed by the Process Committee and addressed in upcoming versions.