[]{#__RefHeading___Toc71008184 .anchor}Software Requirements
Specification

[]{#__RefHeading___Toc71008185 .anchor}Module Name

Advanced Technology QA Consortium (ATC)

DOCUMENT REVISION HISTORY

+------------+--------------+------------------------------------------+
| Version    | Date         | Description                              |
| Number     |              |                                          |
+------------+--------------+------------------------------------------+
| 1.0        | April 2004   | -   Draft                                |
+------------+--------------+------------------------------------------+

[]{#__RefHeading___Toc71008186 .anchor}Background/Summary

The Advanced Technology QA Consortium (ATC) for Clinical Trials Quality
Assurance is supported by a National Cancer Institute (NCI) U24 grant to
Washington University-St. Louis. It functions as a "virtual entity" made
up of the following clinical trials QA Centers: (1) Image-Guided Therapy
QA Center (ITC -- Washington Univ. in St. Louis and UC Davis); (2)
Radiation Therapy Oncology Group (RTOG) Headquarters Dosimetry Group,
(3) Radiological Physics Center (RPC, M.D. Anderson Cancer Center), (4)
Quality Assurance Review Center (QARC), and (5) Resource Center for
Emerging Technologies (RCET -- Univ. Florida Gainesville). It
capitalizes on the existing infrastructure and strengths of national QA
programs. The overall mission of the ATC is to facilitate and support
NCI sponsored advanced technology clinical trials, particularly those
requiring digital submission of protocol accrual data. This effort
includes radiation therapy QA, image and radiation therapy digital data
management, and clinical research and developmental efforts. Efforts are
made to utilize each group's strengths, avoid duplication of existing
programs, and create an environment in which clinical investigators can
receive, share, and analyze volumetric, multimodality treatment planning
and verification (TPV) digital data. 

Table of Content

[Requirements Specification 1](#__RefHeading___Toc71008184)

[Module Name 1](#__RefHeading___Toc71008185)

[Background/Summary 1](#__RefHeading___Toc71008186)

[1 Introduction 3](#introduction)

[1.1 Overview 3](#overview)

[1.2 Related Documents 3](#related-documents)

[2 Actors and Goals 3](#actors-and-goals)

[2.1 \<User Manager\> 3](#user-manager)

[2.2 \<Actor 2\> 3](#actor-1)

[3 Use Cases 3](#use-cases)

[3.1 \<Use Case Name\> 4](#atc-3dcrt-use-case)

[3.1.1 Use Case Model 4](#use-case-model)

[3.1.2 Brief Description 4](#brief-description)

[3.1.3 Primary Actor
4](#primary-actor-the-participating-institution-is-the-primary-actor.)

[3.1.4 Secondary Actors
4](#secondary-actors-actor-2the-itc-actor-3-study-chair-actor-4-dosimetry-qa-reviewer)

[3.1.5 Preconditions 4](#preconditions)

[3.1.5.1 \< Precondition One \> 4](#__RefHeading___Toc71008200)

[3.1.6 Basic Flow of Events 4](#basic-flow-of-events)

[3.1.7 Postconditions 5](#postconditions)

[3.1.7.1 \< Postcondition One \>
5](#if-the-submitted-case-is-a-rapid-review-case-reviewed-prior-to-the-initiation-of-treatment-the-institution-must-receive-approval-prior-to-the-patient-starting-protocol-treatment.)

[3.1.8 Special Requirements 5](#special-requirements)

[3.1.8.1 \< First Special Requirement \> 5](#__RefHeading___Toc71008205)

[4 Overall Requirements 5](#overall-requirements)

[4.1 Requirements Prioritization 5](#requirements-prioritization)

[5 Data Definitions 5](#data-definitions)

[6 Sign Off 6](#sign-off)

[6.1 Approval 6](#approval)

# Introduction

## Overview

## The ATC is committed to the use of advanced medical informatics to create an environment in which clinical investigators can receive, share, and analyze volumetric, multimodality treatment planning and verification (TPV) digital data. Our ultimate goal is to improve the standards of care in the management of cancer by improving the quality of clinical trials medicine. Specifically, we are charged to  {#the-atc-is-committed-to-the-use-of-advanced-medical-informatics-to-create-an-environment-in-which-clinical-investigators-can-receive-share-and-analyze-volumetric-multimodality-treatment-planning-and-verification-tpv-digital-data.-our-ultimate-goal-is-to-improve-the-standards-of-care-in-the-management-of-cancer-by-improving-the-quality-of-clinical-trials-medicine.-specifically-we-are-charged-to .unnumbered}

-   Provide and/or facilitate QA review of RTOG (and other cooperative
    group) clinical trials that utilize advanced technologies including,
    but not limited to, three-dimensional radiation therapy treatment
    planning and delivery (3DCRT), intensity modulated radiation therapy
    (IMRT), stereotactic radiosurgery/radiation therapy, and
    brachytherapy.

-   Assist (facilitate receipt of digital data) QARC in their QA review
    of cooperative group clinical trials that utilize the advanced
    technologies listed above.

-   Assist (facilitate receipt of digital data) RPC in their QA review
    of cooperative group clinical trials that utilize advanced
    technologies.

-   Develop QA and credentialing criteria that is compatible with the
    level of complexity of the clinical trial treatment regimens.

-   Create mechanisms and software tools to facilitate QA reviews of
    treatment planning and verification (TPV) data submitted by
    institutions participating in cooperative group clinical trials
    (both pediatric and adult) that utilize advanced technologies.
    Emphasis to be on the development and improvement of web-based
    remote-review tools that allow for the efficient review of centrally
    located image-based data by reviewers not co-located with these
    data.

-   Develop efficient methodologies for electronic data exchange of TPV
    data between the ITC and the participating institutions, remotely
    located QA review group(s), and cooperative group Operations,
    Statistics, and Data Management Section(s).

-   Develop and maintain an archival TPV database for the advanced
    treatment modalities that can be linked with the cooperative group's
    clinical outcomes database.

-   Serve as a resource to the nation's clinical trial cooperative
    groups and participating institutions for support of high technology
    radiation therapy clinical trials.

## Related Documents

The ATC's web site at [http://atc.wustl.edu](http://atc.wustl.edu/)
provides an overview of the ATC's role in the advanced technology
clinical trials and is used to disseminate advisory information and
pertinent forms to current and potential participants in such trials, to
convey QA review information to participating institutions if needed,
and to facilitate receiving on-line submissions of certain protocol data
and forms.

# Actors and Goals

*\[Actors are classes that define roles that objects external to a
system may play. They are used to model users outside of a system that
interact directly with the system as part of coherent work units. This
include human users and other systems -- see 3.1.3, 3.1.4\]*

## \<User Manager\>

The ITC functions as a User Manager to coordinate/facilitate the QA
review of advanced technology cooperative group clinical protocols that
require digital data submissions.

## \<Actor 1\>

Participating institution (radiation oncologist, physicist,
dosimetrist): The goal of Actor 1 is register a patient to a specific
cooperative group protocol, develop a protocol compliant treatment plan,
and submit the required digital data to the ITC.

## \<Actor 2\>

ITC: The goal of Actor 2 is to perform data integrity QA review of the
submitted data in regard to completeness of protocol required data
objects, format of data, and possible data corruption. Once data
integrity QA is completed satisfactorily, the ITC notifies the
appropriate protocol compliance reviewers.

## \<Actor 3\>

Physician Reviewer: The goal of Actor 3 is to perform protocol
compliance QA review of the RT structures (GTV, CTV, PTV and all
required OARs).

## \<Actor 4\>

Dosimetry Reviewer: The goal of Actor 4 is to perform protocol
compliance QA review of the dose prescription and dose heterogeneity
compliance.

# Use Cases

*\[Repeat sections 3.X for each Use Case\]*

## \<ATC 3DCRT Use Case \>

### Use Case Model

?

### Brief Description

**A. Registration:** participating institution follows standard
registration procedures used by RTOG.

**B. Treatment Plan Development:** The development of the 3D treatment
plan by the participating institution is a function of the protocol
requirements and the patient group stratification.

**C. Treatment Planning Data Submission:** The data which are submitted
to the ITC includes digital patient data and hard copy documentation.
Each portion of the data is due at the ITC at times specified in the
particular protocol. Data submission checklists are maintained on the
ATC web site.

The data to be submitted include digital treatment planning and
verification (TPV) data, simulator and portal films, hard copy isodoses,
and DDSI form as listed below:

-   Set of protocol compliant CT scans

-   Contours (RT structures) of all protocol required organs at risk
    (OARs, i.e., critical structures), gross tumor volume (GTV),
    clinical target volume (CTV), planning target volume (PTV) indexed
    with the CT scan set

-   Beam geometry information (RT Plan) for all treatment fields
    (including fields used only for meeting filming requirements if the
    reference point dose is not the same on filming days as on
    non--filming days)

-   Digital reconstructed radiographs (DRRs) (RT Image) for each beam
    submitted

-   Digital port films (digitized port films or on--line images) for
    each beam (optional)

-   3D dose distributions (RT Dose) for each fraction group of beams

-   DVHs for the total dose to be delivered to patient

The hard copy data items which are due at the ITC are (Note that all of
this "hard copy" is accepted digitally: PDFs, Web forms, JPEGS, etc.):

-   DDSI form identifying the digital data submitted

-   Simulator films for all field in first fraction group (including an
    orthogonal pair of AP and Lateral) if not sent in digital format

-   First day port films of each portal if not sent in digital format

-   First orthogonal pair of port films if orthogonal pair not included
    in fraction group and not submitted in digital form

**D. Digital Treatment Planning Data Submission**

The digital data which are required to be submitted to the ITC can be
conveyed by two different means. The most common method is the use of
s*ftp* (secure file transfer protocol) via the internet. The second
method involves the use of media which is submitted with the hard copy
documentation due at the same time.

For s*ftp* submission, it is necessary for the institution to obtain an
account on the ITC Center\'s ftp file server. This is accomplished by
sending email to *itc@castor.wustl.edu* requesting an account be
established and providing a contact person\'s name and phone number. The
ITC will then contact this individual by phone and provide the necessary
account information for sftp submissions.

To upload patient data to the ITC\'s sftp file server it is necessary to
connect to the server using an sftp client program and connect to
*ITCsubmit.wustl.edu* at which time the account name and password
assigned must be entered. The root directory which is logged into is
specific to each institution to maintain patient confidentiality. It is
then necessary to change into the *incoming* directory. In order to keep
patient data submissions separate within a given institutions file
directory structure, a directory must be created for the particular
patient data to be uploaded into. After this new directory has been
created it must be moved into and then the files may be uploaded. It is
imperative that the files be transferred in binary mode so no conversion
of the data in the files takes place. In the case of media, the data are
written using the utilities provided by the 3D RTP system manufacturer
and then sent to the ITC.

### Primary Actor: The participating institution is the primary actor.

### Secondary Actors: Actor 2(The ITC); Actor 3 (Study Chair); Actor 4 (Dosimetry QA Reviewer)

### Preconditions

#### The use case must be converted from the institution's treatment planning system's proprietary file format to DICOM.

### Basic Flow of Events

Actor 1 (The institution):

-   Identifies a patient that is appropriate to a particular clinical
    trial protocol.

-   Obtains informed consent from patient if patient is willing to
    participate.

-   Registers patient with clinical trial group.

-   Plans Patient treatment according to protocol requirements

-   Sets up SFTP account with the ITC (Actor 2) if submitting data via
    internet.

-   Submits planning CTs, structures, plans, and doses to the ITC either
    using SFTP or using media via express mail.

Actor 2(The ITC):

-   Reviews summary of data to ensure the correct data was submitted.

-   Reviews the data to make sure that it can be extracted for later
    review.

-   Processes data so that it can be later reviewed using the Remote
    Review Tool

    -   Rename structures

    -   Sum fraction groups for total dose distribution

    -   Calculate DVHs

    -   Check and make sure that the submission is roughly protocol
        compliant

-   Forwards the case for review by the study chair (Actor 3).

-   Collects QA scores from the study chair and logs them into a QA
    scoring database.

-   Imports reviewer edited structures if necessary.

-   Refers the case to a dosimetry reviewer (Actor 4).

-   Collects the QA score from the dosimetry reviewer.

-   Notifies institution if any feedback is necessary.

Actor 3 (Study Chair):

-   Receives notification from ITC (Actor 2) that the case is ready for
    review.

-   Reviews the appropriateness of the structures as drawn by the
    institution (Actor 1) utilizing the Remote Review Tool.

-   Forwards the QA scores for the contours and any edits, suggestions
    or request for resubmission to the institution or the ITC.

Actor 4 (Dosimetry QA Reviewer):

-   Receives notification from ITC (Actor 2) that the case is ready for
    dosimetry review.

-   Reviews the protocol compliance of the case in regards to the dose
    constraints as outlined in the protocol.

-   Forwards the scores to the ITC.

### Postconditions

#### If the submitted case is a rapid review case (reviewed prior to the initiation of treatment), the institution must receive approval prior to the patient starting protocol treatment.

### Special Requirements

#### The institution's (Actor 1) computer treatment planning system must have the capability of submitting digital treatment planning data and/or other imaging data to the ITC (Actor 2) in a standard format (DICOM or RTOG Data Exchange) for processing and data integrity QA review.

#### The institution may be required to demonstrate the capabilities of delivering certain types of treatments and the abilities to follow certain protocol requirements prior to enrolling patients on the protocol (credentialing).

####  {#section .unnumbered}

# Overall Requirements

## Requirements Prioritization

  ----------- -------------------------------- --------------------------
  Priority    Use Case Name                    Supp Requirement Ref \#

                                               
  ----------- -------------------------------- --------------------------

\<Comments\>

# Data Definitions

Examples:

Invalid Address -- an address which is not found by the Map Quest
services.

CustomerID -- a unique number generated by the system for each new
Epicentric customer.

# Sign Off

## Approval

*Workspace General Contractor Rep Print Name Date*

*Architecture Workspace Rep Print Name Date*

*VCDE Workspace Rep Print Name Date*

*Workspace Working Group Rep Print Name Date*

*NCICB Rep Print Name Date*