Synta Pharmaceuticals Protocol 9090-08 The GALAXY Study Investigator Meeting BioClinica, Inc. Bio-Imaging Technologies, Inc.

Agenda Imaging Objectives Start-Up Procedures Imaging Data Procedures at Sites Imaging Data Procedures at BioClinica BioClinica Responsibilities Site Responsibilities Imaging FAQs and Challenges Bio-Imaging Technologies, Inc.

Imaging Objectives High Quality Adherence to Imaging Guidelines Consistency in Data Acquisition Completed and Signed Data Transmittal Forms Submittal of Data within 5 Business Days Proactivity in Notifying BioClinica of Imaging Issues/Delays Bio-Imaging Technologies, Inc.

Start Up Procedures: Site Surveys and Study Kits Purpose establishing communication identifying contact information for operative site personnel reviewing imaging equipment, and software archival capabilities identifying site-preferred media Completed by Study Coordinator or Other Site Designee 3 Site Survey Follow Ups Bio-Imaging Technologies, Inc.

Start Up Procedures: Site Surveys and Study Kits BioClinica Team Contact Information Imaging Binder for Storage of Study-Related Forms and Documents Imaging and Submission Guidelines General Principles for Submitting Film Data Frequently Asked Questions (FAQs) Quick Reference Guides (QRG) Digital Archival Media (Pre-Labeled) Film Labels Black Paint Pens Data Transmittal Forms Sample Forms Pre-Addressed Courier Air Waybills Re-Order Supply Form Mailer Envelopes Bio-Imaging Technologies, Inc.

Standardization and Consistency Data Acquisition (Across sites and Timepoints) Equipment Parameters Slice Thickness Ensures consistency in the evaluation of study endpoints Bio-Imaging Technologies, Inc.

Imaging Whole Body Bone Scan, Screening, Q12 Weeks for Subjects with Bony Lesion at Screening, and/or where Clinically Indicated) Contrast Enhanced CT is the Preferred Modality Chest Upper Abdomen MRI is the Preferred Modality for the Brain (at Screening and at Follow Up time points as clinically PET/CT scanners may be used to acquire the above required CT scans if of diagnostic quality, but fused PET/CT images are not acceptable Non-Contrast CT of Chest and MRI of the Brain and Abdomen is recommended for Subjects with Contraindication to IV Contrast PET (must be performed prior to CT with IV contrast) Bio-Imaging Technologies, Inc.

PET/CT Some PET scanners can be used to acquire a CT scan Fused CT/PET scans are not acceptable BioClinica cannot separate a fused CT/PET scan A CT acquired with a PET scanner is acceptable. To obtain optimal quality comparable to diagnostic CT, please adhere to the following: Oral and IV contrast Slice thickness of 3-5 mm preferred Patient positioning Consistency across timepoints for a subject is key Same machine should be used Anatomy should be consistent Bio-Imaging Technologies, Inc.

CT Anatomic Coverage Brain (Baseline and as clinically indicated) Cranial Vertex through Occiput Chest and Abdomen Above lung apices to below illiac crest (to include liver) Bio-Imaging Technologies, Inc.

MRI Anatomical Coverage MRI of Brain (Screening and as Clinically Indicated) Foremen magnum through vertex of skull MRI of Abdomen Above diaphragm through liver to iliac crest Non-contrast CT of Chest Diaphragm through liver to iliac crest Bio-Imaging Technologies, Inc.

Image Submission Procedure Image Data to BioClinica Within 5 Working Days Quick Image Submission Permits the Detection and Correction of Problems Early On Digital Data is Preferred WebSend DICOM Film Data is Acceptable Complete Set of Films All Data Should Be Clean – No Marking Data Transmittal Forms Bio-Imaging Technologies, Inc.

WebSend Web-based solution for expediting the sharing, tracking, archiving and analysis of medical images for multi-center clinical trials with imaging endpoints Protects patient confidentiality by automatically masking PHI Quick and easy implementation Automates the image tracking process Provides complete audit trail with time & date stamps Sites receive email confirmation of image receipt All image data is electronically backed-up and secure

Data Transmittal Form Must be Completed for Each Patient/Timepoint Site Retains Copy in Imaging Binder Submit Original with Image(s) Provides BioClinica with Information Vital to QC and Tracking of Data Site & Patient Identification Imaging Time Point Technical Information Imaging Parameters The identifiers (CRF number and exam date) on the DTF and CD labels must match the scan date imbedded in the data – NOT the study visit date. If you are unsure of the technical information required for the DTF, please ask your radiology department for assistance at the time they perform the imaging. Bio-Imaging Technologies, Inc.

CD and Film Labels CD Labels Film Labels Pre-Printed with Synta Protocol Number and BioClinica Assigned Project Code Sites Complete Fields for: Site Number/PI Name Patient number/Initials Imaging time point Date of scan Film Labels Labels must be affixed to each film submitted. Bio-Imaging Technologies, Inc.

Courier Waybills Pre-Printed Pre-Addressed with BioClinica as Recipient Contains a Unique Project Code (used by BioClinica) Only Sender Information Needs to be Completed by the Site Bio-Imaging Technologies, Inc.

Data Quality Analysis/Quality Control Data Collection Data Log-In/Tracking DTF against Data Translation/Digitization Review Process Technical Adequacy Protocol Compliance DCF if needed BioClinica will provide confirmation of image quality for screening scabs prior to randomization of subjects Bio-Imaging Technologies, Inc.

Communication Methods to Sites Data Clarification Forms Quality Issues, Missing Anatomy, Unacceptable Formatting, etc. Require a Response (5 Business Days) Quality Notification Forms Do Not Require a Response Site Data Summary Reports Outstanding Scans Outstanding Data Clarification Forms Outstanding Surveys Upcoming Scans Bio-Imaging Technologies, Inc.

Data Clarification Forms Generated by BioClinica Requires a Site Response Must Be Returned Within 1 Week Reasons for DCF(s) Discrepancies Missing Anatomy Missing DTF(s) Quality Issues Bio-Imaging Technologies, Inc.

BioClinica Responsibilities Provide Site Survey Provide Imaging Kit Collect Image Data Quality Control Follow-Ups on Outstanding Surveys and Data Address Site Requests and Concerns Bio-Imaging Technologies, Inc.

Site Responsibilities Site Survey Completion Alert Site Personnel to Imaging Requirements Acquire Protocol-Compliant Imaging Proper Labeling of Imaging and Films Completion of Data Transmittal Films Submittal of Data within 5 Business Days Prompt Response to Data Clarification Forms Bio-Imaging Technologies, Inc.

Frequently Asked Questions (1 of 2) Q: Whom should I contact if I have questions about acquiring data per Protocol? A: Your 1st line of contact should be the BioClinica Project Manager. Alternately, the Help Desk is available 24/7. Q: How Can I Acquire More Supplies A: Complete and fax a supply order form, email the supplies contact, or contact the Project Manager Q: Our site has already been contacted by BioClinica about Outstanding Survey information. Why have we been contacted again? A: BioClinica will follow up with sites 3 times for outstanding Surveys. Bio-Imaging Technologies, Inc.

Frequently Asked Questions (2 of 2) Q: Why is it necessary to acquire all images at 5mm? Acquiring images at thicker slices could cause the independent radiologists to miss critical anatomy. Q: In which format should data be submitted? A: All data should be submitted in uncompressed DICOM data. Q: Our site would like data returned. Is this a problem? A: Film data will be returned following digitization at BioClinica. Copies of digital data should be submitted to BioClinica, to be returned at the study’s end. Should original data be submitted to BioClinica before a copy is made at the site, please contact the Project Manager. BioClinica will make a copy and return the original data. Q: Why is it necessary to inform BioClinica of scheduled scans that have not been performed? A: Un-Acquired scans will need to be removed from any reports/ follow ups detailing Outstanding Data. Bio-Imaging Technologies, Inc.

Contact Information Cristen Kelleher Project Manager cristen.kelleher@bioclinica.com Tel: 267.757.3178 Fax: 267.757.1384 BioClinica Supplies supplies@bioclinica.com Tel: 267.757.3002 Fax: 267.757.1380 HelpDesk Toll-Free (US and Canada): 1-888-ASK-BIO2 (1-888-275-2462) Email: helpdesk@bioclinica.com Bio-Imaging Technologies, Inc.