2009 Profile Template Sketch

<<Notes to the editor are shown in italics and angle brackets. When using the template, please substitute appropriate text and delete the angle brackets and surrounding single quote marks.>>

Profile: <<Insert Profile Name>>

This document presents a QIBA Profile for <<Insert Profile Name>>.

Revision Date: 2009-07-08

Status: Exploration Phase Draft (or later, Clinical Trial Phase or Clinical Practice Phase)

Utilities and Indications

<<Describe what can be accomplished by sites that deploy this profile, and what it is intended to be used for.>>

<<Claims go here>>

<<Pull in material from Section 1.1 and 1.7 of the UPICT Protocol>>

Actors and Activities

QIBA has defined the actors and activities in the following table as being necessary to achieving the Claims (or Utilities) described above.

To deploy this Profile, a site must have a compliant person, device or software to take the part of each actor.

To be compliant as a certain actor, a person, device or software must support each of the activities listed for the actor in the following table. The detailed requirements for each activity are documented below.

Actor	Required Activities
Acquisition Modality	Acquisition System Calibration Image Acquisition Image Reconstruction Image Distribution
Measurement System	Image Distribution Measurement Measurement Distribution
Reporting System	Image Distribution Measurement Distribution
Radiologist	Measurement Interpretation
Modality Tech.	Acquisition System Calibration Image Acquisition

Process Flow

<<Sequence Diagram showing how the order/interaction of the Activities>>

<<Would this be a good place for timing relationships? At least by reference?>>

<<Additional description of high-level issues and workflow>>

<<Should we allow activities to overlap (e.g. Imaging Agent Preparation and Image Acquisition) or should we break out a part of the Imaging Agent Preparation and transplant it into the Image Acquisition activity?Or would a reference/pointer from the latter to the former give us the best of both?>>

<<Should we provide requirements/guidance about how to handle exceptions, e.g. the baseline imaging was done slightly/significantly different from the described protocol? (e.g. accept it, or do correction X if they have varied parameter Y, etc.) Should that information go here, or in an Appendix, or separately in a User Guide, or stay silent and let the users make up their own method and guess for themselves what the impact is on the rest of the Profile>>

Activity Definitions

Activity definitions list each of the actors that participates in an Activity and what each is required to do to be considered compliant. Requirements generally cover the inputs actors must accept, the outputs they must produce and the methods they must support, including relevant data formats and semantics.

Activity: Image Post Processing

<<subsequent modification of the reconstructed images. Could include spatial registration/transformation, feature enhancement, 3D view generation, etc.>>

Activity: Image Distribution

<<archiving and/or conveying the images to other systems>>

Activity: Analysis/Measurement

<<generation of information and metrics (e.g. tumor volumes) from the images>>

Activity: Measurement Distribution

<<archiving and/or conveying the measurements to other systems>>

Activity: Interpretation

<<judgements, findings, conclusions>>

Activity: Reporting

<<Details that should go into the report. Structure/format?>>

Activity: <<General Activity>>

<<This is an example of the subsections to put in an Activity when a Profile reaches the Clinical Practice Phase and should have more formal, normative, implementation-oriented contents.>>

Summary

<<Briefly summarize what happens/what is accomplished in the activity.>>

Participants

<<List the participants and in one line identify the nature of their participation>>

Referenced Standards

<<Provide references/pointers to any standards used in the normative text>>

Inputs and Outputs

<<Describe the required inputs and outputs of the activity>>

Expected Actions

<<Describe what each participating actor is required to do to claim compliance>>

<<In addition to carrying out the activity itself, this can also include meta-activities such as calculating and reporting certain metrics, and/or performing self-performance tests>>