central quality management system: reviewer guidelines

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TROG Central Operations Office Level 5, Building 7 Calvary Mater Newcastle Locked Bag 7 HRMC NSW 2310 Tel: + 61 2 49 211 466 Fax: + 61 2 49 211 465 Email: [email protected] Website: www.trog.com.au Central Quality Management System: Reviewer Guidelines Version 3: 12 th December 2012 Trans Tasman Radiation Oncology Group Limited ACN 132 672 292

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TROG Central Operations Office

Level 5, Building 7

Calvary Mater Newcastle

Locked Bag 7 HRMC NSW 2310

Tel: + 61 2 49 211 466

Fax: + 61 2 49 211 465

Email: [email protected]

Website: www.trog.com.au

Central Quality Management

System:

Reviewer Guidelines

Version 3: 12th

December 2012

Trans Tasman Radiation Oncology

Group Limited

ACN 132 672 292

TROG

CQMS: Reviewer Guidelines

Version 3

12 December 2012 Page 2 of 16

Contents

1. Introduction ........................................................................................................ 3

1.1 Access to CQMS ........................................................................................................................................... 3

1.2 e-Learning .................................................................................................................................................... 3

1.3 Helpdesk ...................................................................................................................................................... 3

2. Options for Accessing Dataset ............................................................................. 4

2.1 Download Files ............................................................................................................................................ 4

2.2 Citrix Access ................................................................................................................................................. 4

2.3 Citrix Troubleshooting ...............................................................................................................................13

3. Conducting the Review ...................................................................................... 16

3.1 Notification of Review ...............................................................................................................................16

3.2 Audit Form .................................................................................................................................................16

3.3 Notification of Completion ........................................................................................................................16

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1. Introduction

Central Quality Management System (CQMS) is pivotal to the running of high quality trials in Radiation

Oncology, and we believe that we are setting a world class standard with this innovative system. As a

major infrastructure initiative CQMS will affect all aspects of QA service delivery and provide an

increased capacity for efficient reporting functions providing capability for improvements in trial

quality. CQMS incorporates the use of electronic copies of source documentation to facilitate review of

protocol compliance and data accuracy. A highlight of the system is the ability to transfer radiotherapy

treatment planning files (RTP) for remote review via a 3D review software package, SWAN, which was

developed at Sir Charles Gairdner Hospital, Perth.

You have been selected as a quality assurance reviewer and the following guidelines will instruct you

on how to complete a review using CQMS.

1.1 Access to CQMS

CQMS is accessed via a secure log-in on the TROG website www.trog.com.au. Simply click on the link

on the left-hand side of the homepage and you will be taken to the log-in page for the system.

You have been issued with a unique username and password which you should enter into the specified

fields on the log-in page. If you didn’t receive these or if you have any trouble logging into the system

please contact the Helpdesk ([email protected]).

1.2 e-Learning

An e-learning package has been provided to guide users through the use of CQMS and SWAN. The e-

learning lessons can be accessed via the TROG website.

1.3 Helpdesk

The CQMS Helpdesk is available to answer any queries relating to the use of CQMS/SWAN and the

associated e-learning training package. Please contact the CQMS Helpdesk on the following email:

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[email protected]. To assist us in providing you with appropriate support please include a detailed

explanation of your query. The CQMS Helpdesk will respond to your query within one working day.

2. Options for Accessing Dataset

There are 2 options available to access an RTP dataset in CQMS. The first ‘download’ option enables

you to save the dataset to your computer directory and view the files on your locally installed version

of SWAN. The second option, using the ‘Citrix Platform’, provides the alternative of accessing a secure,

internet-based version of SWAN where you have immediate access to the required dataset. The

following information provides guidelines on how to access the datasets using the 2 available options.

2.1 Download Files

2.1.1 Instructions

Once you have entered your log-in details in CQMS you will be presented with your personal desktop.

Click on the ‘audit form created’ link which is located in ‘My Forms’ as shown below.

My Forms

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When you click on the link you will be taken to an audit form for that site/patient.

To expand each section click on the headings. The audit form contains a listing of the files that have

been uploaded from the site. To download the files you must click on the ‘download files’ link as

demonstrated below.

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When you click on the link a window will pop-up and will give you the option to open or save the

file. Please click on the save button.

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Browse within your local file directory and save to a memorable file location.

Depending on computer speed, the file download should take approximately 1 minute. When

the files have finished downloading, a notice will appear stating the download is complete. You

will be given the option to ‘Open Folder’. Click on this button.

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You will be directed to the file location where you saved the file. Double-click on the file name.

On the left-hand side of the file directory under the heading ‘Folder Tasks’ you will be given the

option to ‘Extract all files’. Click on this option, as the files are contained within a zipped folder

and to access the files you will need to unzip the folder.

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An ‘extraction wizard’ will appear on screen. Follow the instructions in the wizard, by pressing

the next button.

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Once the files have been unzipped, you will be able to open them in your locally installed version

of SWAN. Open the SWAN software and select the file type, either DICOM or RTOG. Then go to

‘file’ and select ‘import’.

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Search within your local directory to the location where you saved the files and click ‘open’. You

will have to scroll through a number of folders to get to the folder which contains the images –

this folder is blank (doesn’t contain any files) but please click the ‘open’ button and they will then

open in SWAN.

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You can now proceed to review the files as per normal SWAN guidelines.

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2.2 Citrix Access

You can view the dataset via a centrally located copy of SWAN which is stored on a Citrix

platform. Simply click the 'SWAN' link which is located on the top toolbar of CQMS to access this

system.

You will be directed to a secure website where you must enter your log-in details. These have

been sent to you via email notification and must be changed at your first logon.

The first time you use the system, the Citrix Client Software may have to be loaded onto your

computer. This will happen automatically if required. If you have any problems please refer to

the following section 2.3 for troubleshooting guidelines or contact the helpdesk on qa-

[email protected].

If a box titled ‘Client File Security’ appears please click the ‘full access’ box which is listed under

the heading ‘What access do you want to grant?’ Then click ‘OK’. The SWAN icon should appear

in Applications box on the left-hand side of the page. Click on the icon. You will be taken to the

homepage of the SWAN software. The Citrix version of SWAN operates with the same functions

as a locally installed version. If you require any training on the use of SWAN, please refer to the

SWAN e-learning lessons on the TROG website.

2.3 Citrix Troubleshooting

The first time you launch SWAN using the Citrix platform you may encounter a loading error

message. This section provides troubleshooting guidelines on how to resolve this issue. If you

are not comfortable following the instructions below, or this procedure fails to resolve this error

then contact your local IT support and ask to have the Citrix Web Client Software loaded on your

computer.

If you receive the ‘Proxy Failure: No JavaScript Support’ error when launching SWAN, this is an

error caused by the settings of your browser, when Citrix attempts to load the ICA Client on your

computer.

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To resolve this issue, on your computer:

• Launch Internet Explorer

• In Internet Explorer select Tools > Internet Options

• Select the ‘Connections’ tab

• On the ‘Connections’ tab click the ‘LAN Settings. Button’.

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• On Local Area Network (LAN) Settings take note of the current selected options, as these will

need to be restored at the completion of the Citrix ICA Client installation.

• On Local Area Network (LAN) Settings window check the option called ‘Automatically detect

settings’ and uncheck the option called ‘Use automatic configuration script’. Click the OK

button to apply these changes.

• On the Internet Options tab click the ‘Apply’ button

• Click the refresh icon to initiate the client detection process

If you still receive the following error:

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Follow the above steps to restore your Local Area Network (LAN) Settings, then contact your

local IT support and ask to have the Citrix Web Client Software loaded on your computer.

3. Conducting the Review

3.1 Notification of Review

The TCOO will contact you by email to notify you when a dataset is ready for review. You should

then log-in to CQMS and on your desktop page you will be presented with a link under ‘My Forms’ to

an audit form where the dataset will be saved.

3.2 Audit Form

Dependent on the trial in which you are a reviewer, you will either complete an audit form in CQMS

or be emailed a separate form for completion.

3.3 Notification of Completion

Once you have completed the case review, please contact the trial QA coordinator at the TCOO by

email to notify of the completion.