Difference between revisions of "Assessment Procedure Guidance"

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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.
 
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.

Revision as of 21:20, 19 April 2017

<THIS IS STILL A DRAFT UNDER DEVELOPMENT - Should be ready 2017Q2 >

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).


Suggestions

Submit suggested improvements/gaps by adding bullets here:

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

Past Versions