ACR IMAGING CORE LABORATORY PET and PET/CT Scanner Qualification Program User Manual QUIC Web-based Qualification Tool Version 2 April 15, 2013
CONTENTS Overview... 2 Availability... 2 System Requirements... 2 Password Management... 3 Menu Overview... 3 Home Page... 3 Modalities... 5 Scanners... 6 New Qualification... 8 Application Submission... 8 Image/Exam Submission... 10 Adding Files... 12 Upload Limitations... 12 Adding/Deleting Exams... 12 Qualification Results... 13 Adding Comments... 15 Image Downloads... 16 ACR Review... 17 Deleting Images/Files... 18 Renew Qualifications... 19 Search Qualifications... 21 Account Management... 22 Update Profile... 23 Change Password... 24 Page 1 of 26
Sign Out... 25 FAQ... 26 OVERVIEW The PET qualification program is coordinated by the ACR Imaging Core Laboratory (core lab). The program helps to ensure that PET scanners used for scanning clinical trial study participants meet required standards so that the quantitative, semi quantitative, and qualitative information contributed by sites to a trial is reliably of high quality. The qualification process includes submission of an application and uploading of images and data forms. PET qualification instructions are available on the ACRIN Web site at: PET Qualification. To verify that a PET scanner maintains required performance, requalification is required annually. The Qualification Utility for the Imaging Core Laboratory (QUIC) is a Web-based tool that provides an efficient means for managing the PET scanner qualification process and communicating with the core lab staff. By registering for access to the QUIC Web site, site personnel can complete the online PET qualification, upload images, track the review process, and receive timely updates. Information about a PET scanner s qualification expiration is also available to help sites plan ahead for requalification. How QUIC Works QUIC can be accessed from any browser at: https://quic.acr.org. When logging into the QUIC Web site for the first time, users are prompted to create a login name and password. Submission of an application and images triggers notification to the core lab staff to begin the review process. Core lab staff update the qualification status (qualified/not qualified), which triggers e-mail updates to site users. AVAILABILITY The QUIC Web site is currently available for sites participating in clinical trials using PET. SYSTEM REQUIREMENTS Below are the recommended system requirements for QUIC: Windows OS (ex. Windows XP, Windows 7) Up-To-Date Browser (ex. Internet Explorer, Firefox, Google Chrome) Java Version 6 or higher (required in order to upload images/files). You can check your version of Java at http://java.com/en/download/installed.jsp. Page 2 of 26
PASSWORD MANAGEMENT Users who forget their password are directed to go to: https://quic.acr.org/pages/forgotpassword.aspx. There the user enters a login name and clicks the Get Password button. A new password is then generated and forwarded to the user s e-mail address. After logging in with the generated password, the user goes to the Change Password menu to changes that password. MENU OVERVIEW Site users have access to the following site menu options on the QUIC Web site: Home Presents a summary of the most recent site qualifications Modalities Allows the user to view information for each modality available in QUIC Scanners Allows the user to view all site scanner information and also to register a new scanner New Qualification Allows the user to start a new qualification process Renew Qualification Allows a user to renew an existing qualification Search Qualifications Allows the user to search existing qualifications My Account Allows the user to perform account management functions (update profile, change password, and sign out of the QUIC Web Site) FAQ - Lists frequently asked questions for using the web site HOME PAGE The Home page shows the current status (see Table 1 for status descriptions) of the site(s) qualifications. By clicking a column header link (QualificationCD, ScannerCD, ModalityCD, etc.), the data shown in the table will be sorted by the selected column. In Figure 1 Home Page, the page is sorted by Status Date. The user can also navigate to the Qualifications Details page by clicking the respective scanner Qualification CD in the first column. The complete scanner, modality and site names can be shown by holding the mouse over a ScannerCD, ModalityCD or SiteID in the table (ToolTips). Users can also navigate to the scanner or modalities details pages by clicking the ScannerCD/ModalityCD links in the table. Page 3 of 26
Figure 1 Home Page Table 1 Qualification Status Descriptions Status Qualified Not Qualified Incomplete Submitted Expired Suspended Resigned Description Qualified Not Qualified Pending Resolution Incomplete Pending Submission Submitted Pending Approval Expired Suspended Resigned Page 4 of 26
MODALITIES The Modalities Home Page shown (Figure 2) displays all modalities available for qualification and their status. Figure 2 - Modalities Home Page By clicking on the Modality CD in the first column you are taken to the Modality Details page (Figure 3) where information such as modality name/status/code/description, ACRIN studies that require the modality and exams expected during qualification for the initial/renewal timepoints are displayed. Page 5 of 26
Figure 3 - Modality Details SCANNERS The Scanner Home Page shown (Figure 4) lists all scanners at the user s site(s). Users can also filter the list by Scanner CD, Scanner Name, Site, and Status. Filtered scanner results can also be exported to an Excel file by clicking the Export button. To view existing scanner details, the user can click the Scanner CD link displayed in first column of the table. Clicking the link will take you to the Scanner Details Page shown in Figure 5. Users can edit the scanner details on this page and also view all Qualifications linked to the scanner. Once a scanner has been qualified, no further edits will be allowed to be made to the scanner details. To register a new scanner click the Register New Scanner button from the Scanner Home page. Page 6 of 26
Figure 4 - Scanner Home Figure 5 - Scanner Details Page 7 of 26
NEW QUALIFICATION To start a new qualification process, the user selects New Qualification (Figure 6) from the left-hand navigation menu. Figure 6 - New Qualification Users can request scanner qualifications only for sites with which they are currently affiliated in their user profile. After selecting the required site, scanner and modality the user clicks the Create New Qualification button to establish a new qualification. The user is then directed to the Qualification Details page. APPLICATION SUBMISSION On the Qualification Details page, the user must complete all required fields presented on the Application tab (Figure 7) and then click Save. After saving the completed application, the user clicks the Submit button. Required fields are marked with *. Users can also navigate between the Scanner and Modality Details pages by using the appropriate header links shown on the page. Page 8 of 26
Figure 7 - Qualification Details Page: Application Tab Page 9 of 26
IMAGE/EXAM SUBMISSION Next, the Images tab (Figure 8) is used to upload the required images/exams for the modality. An exam name is required before any images can be uploaded. The user can select a predefined exam name from the drop-down list or enter a custom exam name. Figure 8 - Qualification Details Page: Images Tab After saving the exam name by clicking the Save link, the user clicks the Upload Files link to begin uploading files. This opens the Upload DICOM Files dialog window shown in Figure 9. Page 10 of 26
Figure 9 - Upload DICOM Files Window In order to upload files, the user must grant permission for the application to run by clicking Run on the Java Application Security Message window shown in Figure 10. The user can stop this warning message from displaying again for future uploads by checking the Always trust content from this publisher box and then clicking the Run button. A more detailed explanation of how to upload files/exams is specified in the Adding Files, Upload Limitations, and Adding/Deleting Exams sections of this manual. After all files/exams have been uploaded, the user clicks the Submit To ACR For Review button to complete the image submission part of the qualification process. Figure 10 - Java Application Security Message Page 11 of 26
ADDING FILES The easiest way for the user to add files to the upload window in Figure 9 is to open the source images/files in Windows Explorer (assuming the user is using a Windows-based computer) and then use one of the following procedures: Click and drag the entire exam folder from Windows Explorer to the Upload DICOM Files window in the user s Web browser <or> Select the files individually in Windows Explorer, select Copy, then select Paste on the upload window in the user s Web browser <or> Click the Add Files button on the upload window in the user s Web browser, and then browse to exam location on computer to select files for uploading. Once all files have been added, the user clicks the Upload Files button to start uploading the files to the central server. The Upload DICOM Files window will show the progress of the upload and the number of files that were successfully uploaded or failed to upload. The user can resubmit any files that failed to be uploaded to the server by clicking the Retry failed button in the menu bar of the upload window. UPLOAD LIMITATIONS Only the following file types can be uploaded to the server (all other file types will not be uploaded): DICOM and Image files (DCM, GIF, JPG, JPEG, BMP, PNG) Text files (TXT, RTF) Adobe PDF files (PDF) Microsoft Excel files (XLS) Microsoft Word files (DOC) Users can add/upload a maximum of 2000 files to the upload window. Files cannot be over 100 MB. The total combined size of all files cannot be over 1 GB. ADDING/DELETING EXAMS If a modality requires multiple exams to be submitted, the user clicks the Add Another Exam link on the Images tab to add another exam row. The user can also delete an exam by clicking the Delete Exam link located on the right side of each exam row. Note: Deleting the exam row will also delete ALL files that have been uploaded for the exam. Page 12 of 26
QUALIFICATION RESULTS Once the application and images are qualified, a certificate will be generated and available for download on the Results tab shown in Figure 11. Click the Download Files link on the Results tab of the Qualification Details page to download any qualification result files. These files can be downloaded at any time. Once all files have been zipped (see Figure 12), click the Click to Get Your File button as shown in Figure 13 to download the zip file to the user s local computer. If multiple result files are listed, the check boxes in the first column of the table can be used to combine all files into a single zip file (batch download). Use the check boxes to select multiple files and click the Download Selected link generate a batch download. Figure 11 - Qualification Details Page: Results Tab Page 13 of 26
Figure 12 - Result File Download in Progress Figure 13 - Completed Download Page 14 of 26
ADDING COMMENTS The Comments tab (Figure 14), allows the user to add any additional information thought to be useful to the reviewers during the qualification process. The history of all comments added to the qualification is shown in the top grey text box. The user enters new comments in the bottom text box, and then clicks the Add Comments button. Checking any of the check boxes to the left of the Add Comments button e-mails the comments to various recipients. This step is optional and not required. Figure 14 - Qualification Details Page: Comments Tab Page 15 of 26
IMAGE DOWNLOADS Users can download images for each exam by clicking the Request Download link on the Images tab shown in Figure 8. The history of all image download requests will be shown in the Image Downloads tab shown in Figure 15 below. Once a download request is completed, users will receive an email that includes a link to the exam zip file. Users can also open/save the zip file from clicking the Get Zip File link in the Image Downloads tab. Any completed downloads will expire when either condition below is met: After 2 weeks from the download completed date If an exam is changed (images uploaded or deleted) Figure 15 - Qualification Details Page: Image Downloads Tab Page 16 of 26
ACR REVIEW E-mail notifications are sent to the core lab staff once the application and images are submitted when the user clicks the respective submit buttons on the Application and Images tabs. After application submission: the application tab status is changed to Submitted - Pending Approval, and no further changes can be made to the application form data After image submission: the image tab status is changed to Submitted - Pending Approval, and no further files/exams can be uploaded After application and image submission: the qualification status changes from Incomplete to Submitted. The qualification will now be reviewed by a member of the ACR Imaging Core Laboratory staff. The user is notified via e-mail regarding the status of each qualification. If a qualification is not approved for any reason, the user is notified and allowed to correct the application or upload additional images as required. Page 17 of 26
DELETING IMAGES/FILES Clicking the DELETE FILES link on the Images tab of the Qualification Details page allows the user to delete files individually for an exam. This opens the window shown in Figure 16. The user can select all files by checking the Select All checkbox at the top left of the window. A second option is to select one or more consecutive files by clicking and, keeping the click button depressed, moving the mouse downward to select the desired files. A third option is to select individual files while holding the Ctrl key, and then to click the DELETE FILES button at the bottom of the window to delete the selected files. Note: Images/files cannot be deleted after they have been submitted for ACR review or once they have passed the review. Figure 16 - Delete Files Window Page 18 of 26
RENEW QUALIFICATIONS Users can Renew Qualifications by selecting the Renew Qualification menu. The Renew Qualification Home page (Figure 17) is shown which lists all qualifications available for renewal. Clicking on the QualCD, ScannerCD or ModalityCD links shown in the table will take you to the applicable details page. Click the Renew button to start the Qualification Renewal process. As shown in Figure 18, select the site, scanner and modality which you wish to renew. If the combination of site, scanner and modality selected for renewal is not valid, an error will be displayed. Click the Renew Qualification button and you will be directed to the Application Details page where you would fill out the application and submit images using the same instructions as specified in the New Qualification section. Figure 17 - Renew Qualification Home Page Page 19 of 26
Figure 18 - Renew Qualification Page Page 20 of 26
SEARCH QUALIFICATIONS The Search Qualification page (Figure 19) can be used to search all qualifications created for the sites with which the user is affiliated. The search results return qualifications created by a user as well as those created by other users affiliated with the same sites. Search results can also be exported to an Excel file by click the Export button. Clicking the QualificationCD, ScannerCD or ModalityCD links in the table will take you to the appropriate details page. Figure 19 - Qualification Search Page Page 21 of 26
ACCOUNT MANAGEMENT The My Account menu in the QUIC Web site includes the following options: Details of each option are explained below. Page 22 of 26
UPDATE PROFILE The Edit User Profile page (Figure 20) allows the user to update the First/Last Name and E-mail Address fields. Login Name, Role, Status, and Selected Facilities are read-only fields. The user can also access the User Profile page by clicking the user name link located above the left-hand navigation menu. Figure 20 - Edit User Profile Page Page 23 of 26
CHANGE PASSWORD The Change Password page (Figure 21) allows the user to change his or her password for the Web site. Figure 21 - Change Password Page Page 24 of 26
SIGN OUT The Sign Out page (Figure 22) logs the user out of the QUIC Web site and ends the session. The user can also sign out by clicking the signout link located above the left-hand navigation menu, next to the user name link. Figure 22 - Sign Out Page Page 25 of 26
FAQ Common questions regarding QUIC can be found on the FAQ page (Figure 23). Figure 23 - FAQ Page Page 26 of 26