1. American College of Radiology Imaging Network (ACRIN) Site Webinar Series: TRIAD Installation and QA Transfers September 15, 2010

2. DTCC Organization

3. Diagnostic Testing Activation MGH/ACRIN Technical Evaluations  E-mail from MGH to SC containing links to six online evaluations (1/modality)  Submitted with seven (7) days TRIAD Installation & QA (Sample) Data Transfers  Introductory e-mail from ACRIN to SC  Followed by consult call with SC and/or primary IT contact to discuss TRIAD installation(s)  Site trained on TRIAD during installation  QA (Sample) data sets requested for each imaging modality Cardiac CTA Case Review  MGH oversees this step, CT readers perform sample case reviews 3

4. Technical Evaluation Must be completed prior to TRIAD installation “Green light” for ACRIN to begin communications with site Emphasizes the central role of the study coordinator both pre- and post- site activation Establishes the contacts and conditions for data transfer across all modalities Allows sites to chose the most efficient IT setup for data transfer 4

5. TRIAD Letter & Consultation Call TRIAD Greeting Letter is sent (via e-mail) to Site SC  Prepares your organization by providing requirements for an installation of ACR’s image acquisition and management software, TRIAD ACRIN holds site consultation call with each site  Site SC should be prepared to confirm the following information:  Installation plan/process for image transfer  Number of TRIAD installs required  ACRIN will confirm the following with site:  Number of QA submissions required  TRIAD installation date (if applicable) TRIAD Installation occurs on scheduled date/time (ACRIN)  Site will be required to submit a test exam during installation to confirm successful TRIAD deployment Upon completion of the TRIAD install, QA (sample) data submission letter sent to sites via e-mail 5

6. What is TRIAD?? TRIAD is the American College of Radiology Imaging Network’s (ACRIN) image acquisition and management software. It offers a web-based software solution which allows sites a secure method to review and submit images.

7. Selecting TRIAD Options TRIAD setup is customizable with two (2) basic options for submission of images originating from, or routed through, the Clinical Site:  Installation of TRIAD client application only (installed on a PC!!! requires transfer of the test data sets from onto CD on local PC)  Recommended for low volume sites (Fewer than five submissions/month anticipated)  Installation of TRIAD site server (For transfer of images directly from PACS or modality (i.e. CT scanner))  Recommended for high volume sites, especially for CT (50% of cases will be CT) if five or more submissions/month anticipated) 7

8. TRIAD PC Requirements TRIAD Rich GUI Client Requirements Model: PC Processor: Minimum: Pentium IV 3GHz Recommended: Intel Core 2 Duo Processor 2GHz RAM: Minimum: 1GB, Recommended: 4GB Hard Drive: Application installation: 200MB Local cache: Minimum: 50GB, Recommended: 200GB Display: Graphic adapter and Monitor with True Color mode support 1024 x 768 pixels x 32 bit color mode Operating system: Windows XP SP3 and Windows 7 Pre-requisites: Microsoft.NET Framework 3.5 TRIAD Site Server Requirements Model: PC Processor: Minimum: Pentium IV 3GHz Recommended: Intel Core 2 Duo Processor 2GHz RAM: Minimum: 1GB, Recommended: 4GB Hard Drive: Minimum: 50GB Recommended: 200GB Operating system: Windows XP SP3, Windows Server 2003 SP2, Windows 7 Pre-requisites: Microsoft.NET Framework 3.5 and Microsoft SQL Server 2005 Express 8

9. Should be sent to ACRIN within five (5) days of receiving letter 1 dataset per imaging modality (with the exception of ECG) All image data (both sample and trial cases) should be in DICOM format Data submitted to ACRIN must be deidentified TRIAD will anonymize image headers Watch for patient identifiers on the images themselves - Echo data  Turn off the feature that displays subject identifiers on the images. Please contact your the application specialist appropriate to your ultrasound machine or the technician that services your ultrasound machine if you have questions regarding this feature.  Enter study ID numbers rather than patient name at the time of image archival and submission. This will leave the display on, but the information displayed should be free of any personal heath information. Select “QA” when submitting images Diagnostic Test Transmittal Worksheet (DTTW) required for sample data as well as each case during the trial Preparing QA datasets 9

10. Preparing QA datasets - CTA Pay special attention to include a dose report, often called a “protocol page” Choose an exam that includes a non-contrast enhanced CT for the measurement of coronary artery calcium (non-contrast)

11. Preparing QA datasets – Stress ECHO Only the standard four (4) views used in a Stress Echo - 4 resting and 4 peak/post are required. Apical long axis can be substituted for PLAX if necessary. Additional images, such as a full 2-D study, Doppler or M- mode may be included but are not required for the trial The percentage of the endocardial border visualized should be at least >75%. If less then LV echo contrast is recommended. Digital ECG waveforms must be included on the images

12. Preparing QA datasets - SPECT The following images are submitted in DICOM format:  Raw rest and stress (unprocessed) planar gated and non-gated images (projection files).  If Attenuation Correction is used, BOTH the Attenuated Corrected images and the Non-Attenuated corrected images are submitted to ACRIN.  If possible, an image of the Beat Length Histogram is submitted in DICOM format or as a JPEG, TIFF or BMP screen capture. Please note that the following “processed” images are not required, but may be sent if it is more convenient for the techs to send many files instead of just raw files:  Reconstructed stress-rest slices  LV Volume Curve & calculated Left Ventricle Ejection Fraction images  Quantitative data, polar maps etc.  Movie gated SPECT slices  Gated SPECT slices in end diastole & end systole

13. QA (sample) data will not be required during site activation period Quality Assurance performed on first study patients Each lab (Stress ECG alone, Nuc Med Imaging, Stress Echocardiography) will be qualified separately, but subject enrollment is not dependent on this step MGH will provide all sites with FedEx airbills (preprinted with the ACRIN address) for mailing ECG waveforms Sites will be asked to mail their ECG waveforms in groups of five (5) studies per package or once a month, whichever comes first. Special Note on ECG waveforms 13

14. Datasets should be consistent with Diagnostic Testing Protocol Recommendations  Included in Manual of Operations  Also available at www.promisetrial.org - under ‘Diagnostic Testing Centers’ tabwww.promisetrial.org ACRIN Image Technologists complete Technical Quality Assessment (TQA) form, review data for completeness of dataset and quality of images Specific Criteria will be reviewed Quality Control Procedures 14

15. Feedback from ACRIN Case Query Notification (Z5)  Response Requested  May request new dataset Case Acceptance Notification  E-mail from ACRIN to Study Coordinator  Sent after each imaging modalities is approved  No Response Required QA Approval Letter  E-mail from ACRIN to Study Coordinator  Sent after ALL imaging modalities have been approved 15

16. Frequently Asked Questions What if we have security concerns regarding TRIAD?  ACRIN has made several materials available to sites to address your security concerns, they are as follows:  ACR TRIAD Security Overview document  TRIAD SSL Certificate  These documents can be found on the trial website: www.promisetrial.org under the “Diagnostic Testing Centers” tab www.promisetrial.org

17. Frequently Asked Questions The image upload time from CD/DVD to TRIAD is taking much longer than expected?  There are two options you have to help eliminate this problem, they are:  ACRIN can provide your site with additional installations of TRIAD, allowing multiple users to push images directly to ACRIN  ACRIN can install TRIAD Site Server, if you originally received TRIAD Client only. This will eliminate the need for DVD/CDs and allow your site to select/transfer images stored on a PACS or modality on the same local area network  In the interim, we would advise you to start the upload when you leave work!!

18. Frequently Asked Questions May we submit images for the trial directly to ACRIN via DVD/CD ?  The short answer, no  Due to the size of the image files (mainly CTA), DCRI, MGH and ACRIN are asking all sites to submit images via TRIAD  We are more than happy to speak with your site individually to address any concerns you may have

19. Frequently Asked Questions I am having difficulty getting my hands on the correct data sets for QA submission, what should I do?  Get in touch with your lead technologist or MD (cc’ed on intro email)  Send them the QA/QC criteria for completeness and quality so they know what we are looking for  Known major road blocks – contact our specialists!!  SPECT – image format  Stress ECHO – de-identification  CTA – complete data set with calcium scoring, multiphase imaging, and radiation report

20. Team Members ACRIN Administrative Contacts  Principal Investigator – Charles Apgar  Phone: (215) 574-3231  E-mail: capgar@acr-arrs.orgcapgar@acr-arrs.org  Project Manager – Heather Polley  Phone: (215) 574-3245  E-mail: hpolley@acr-arrs.orghpolley@acr-arrs.org  Project Support – Renee Stolyar  Phone: (215) 574-3172  E-mail: rstolyar@acr-arrs.orgrstolyar@acr-arrs.org 20

21. Team Members ACRIN Imaging Contacts  Computed Tomography Technologist – Dena Flamini  Phone: (215) 940-8880  E-mail: dflamini@acr-arrs.orgdflamini@acr-arrs.org  Nuclear Medicine Technologist – Adam Opanowski  Phone: (215) 940-8890  E-mail: aopanowski@acr-arrs.orgaopanowski@acr-arrs.org  Echocardiography and Stress ECG Technologist – Aimee Jordan  Phone: (215) 940-8839  E-mail: ajordan-t@acr-arrs.orgajordan-t@acr-arrs.org 21

22. The materials mentioned in this presentation are available at www.promisetrial.org 22 Question and Answer Session