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PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9 th , 2006

PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9 th , 2006. Agenda. Bio-Imaging Overview Role of Bio-Imaging Imaging Requirements Bio-Imaging Responsibilities Site Responsibilities. Bio-Imaging Overview. Imaging Core Lab

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PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9 th , 2006

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  1. PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9th, 2006

  2. Agenda • Bio-Imaging Overview • Role of Bio-Imaging • Imaging Requirements • Bio-Imaging Responsibilities • Site Responsibilities

  3. Bio-Imaging Overview • Imaging Core Lab • Standardization of Imaging • Collection and QC of Image Data • Independent Review of Image Data • State-of-the-Art, FDA Compliant Centralized Core Labs • Newtown, PA • Leiden, The Netherlands • 269 Employees • 201 USA • 68 Leiden

  4. Role of Bio-Imaging • Obtain High Quality Standardized Image Data • Standardized Imaging Protocol • Ensures Consistent Acquisition Across All Clinical Sites and Imaging Timepoints • Standardized Procedure to Submit Image Data • Provides Image Data in Standard Format • Perform Independent Blinded Review • Maximize Power of Image Data

  5. Study MO18264 (PRIMA) • Imaging Endpoints • Progression Free Survival from maintenance randomization (PFS) defined as the time from randomization to progression, relapse, or death from any cause.

  6. Imaging Requirements • Timepoints • Baseline • Induction • Maintenance • End of Treatment • Follow-up • Anatomical Region • Chest, Abdomen, Pelvis

  7. Imaging Requirements • Scans Must be Performed Consistently Between All Timepoints to Assess Endpoints • Same Scanner & Technique Must be Used Throughout the Trial

  8. Retrospective Data Collection • Retrospective Study Kit • Instructional Letter • Contains basic instructions • Retrospective Data Transmittal Forms (rDTF) • Film Labels • Pre-addressed Waybills • Supply Reorder Forms • Envelopes/Padded Mailers • Paint pens • Used for blinding films

  9. RetrospectiveData Transmittal Forms (rDTF) • rDTF can be completed by Monitors, CRA’s or site • Multiple patients (3) can be listed on one rDTF • Each retrospective timepoint must be accompanied with an rDTF.

  10. Image Submission Procedure(Retrospective) • Provide Complete Image Data Set • Film or Digital Data Must be Submitted • Include Retrospective Data Transmittal Form • Ship all data to Bio-Imaging using the provided envelopes/padded mailers and pre-addressed Waybills • All Retrospective data should be sent to our Newtown Office

  11. Imaging Study Kit • Imaging Study Kit (for prospective data) • Imaging Guidelines • Includes blinding instructions • Image Data/Archival Transmittal Instructions • Data Transmittal Forms • Pre-addressed Waybills • Supply Reorder Forms • Paint Pens • Image Archival Media • Optical Disks, Tapes, CDs

  12. Imaging Guidelines • Provide Detailed Imaging Requirements • Sets Standards for Proper Image Acquisition • Defines Timepoints for Imaging • Sample Images, Both Correct and Incorrect • Blinding • Shipment of Images • Bio-Imaging Contact Information • Important for Radiology Technologists to Read and Understand Guidelines

  13. Image Submission Procedure(Prospective) • Provide Complete Image Data Set • After Each Timepoint • Submit Within 2 - 5 Days of Scan • Digital Data Must be Submitted • Include Data Transmittal Form

  14. Blinding/Masking ProceduresFilm and Digital • Blinding Film Data • Black paint pen are provided to blind/mask sensitive data • Do not place tapes or stickers on the films. • Only use labels provided by Bio-Imaging • Do not place labels over the imaging parameters on the film. • Blinding Digital Data • Digital data should be anonymized (masked) prior to archiving, by utilizing the study specific Investigator Number, Patient Number and Patient Initials.

  15. Blinding/Masking Procedures(continued) • Bio-Imaging will strictly maintain patient confidentiality at all times. • In the event that unmasked data is unintentionally submitted, Bio-Imaging will remove patient identifiers. • A Quality Notification Form (QNF) will be forwarded to the site

  16. Image Data Flow Initial QC Transmit Log/Track Digitize or Translate Site Independent Review Site Preparation & Standardization Image QC & Archival

  17. Data Transmittal Form • Provides Bio-Imaging with Vital Information to QC and Track Image Data • Site and Patient Identification • Imaging Timepoint Information • Imaging Parameter Information • Must be Completed for Each Timepoint • Submit with Image Data • Three (3) Part NCR Form • Site Retains Pink Copy

  18. Media • A Media Label Must be Present on All Image Data Submitted to Bio-Imaging • Digital Media will be Supplied with an Attached Pre-Printed Label but Needs to be Completed by Site

  19. Courier Waybills • Provided With Pre-printed Courier Waybills • Pre-addressed With Bio-Imaging as Recipient • Sites Must Complete Sender Information • Contains a Unique Project Code • Bio-Imaging specific

  20. Central Image Collection • Data Collection • Coordinate • Log and Track • Initial QC of Image Data • Preliminary Check • Image Data Clarifications • Image Data Tracking

  21. Image QA/QC Review • Performed by Radiology Technologist • Protocol Compliance • Technical Adequacy • Rapid Review Process • Detect Problems Early • Prevent Backend Delays

  22. Communication To Sites On Quality • Data Clarification Form (DCF) • Query Regarding • Imaging Data Received • Data Transmittal Form (DTF) • Quality Notification Form (QNF) • Notice on Quality of Imaging • Identify Improvements Needed for Future Imaging

  23. Image Data Clarification Form • Generated by Bio-Imaging • Requires a Site Response • Must be Returned within 1 Week of Issuance of Original DCF Form

  24. Reasons For Queries • Missing Demographic Information on DTF • Patient registration #, Patient initials, etc… • Mismatch Between DTF and Digital Media/Films • Site Not Consistent with Imaging Parameters Between Timepoints • Clarification of Information • Missing Image Data • Missing Forms (DTF) • Repeat Scans (Quality Issues)

  25. How To Ensure Quality At Your Site • Establish Communication with Radiology Department • Communicate Regularly With Radiology Department • Schedule Patients in a Timely Manner • Ensure CT Scan Consistency • Timely Submission of Images to Bio-Imaging

  26. Site Responsibilities • Notify Radiology Dep. of Imaging Requirements • Perform Protocol Compliant Imaging • Proper Labeling of Image Data • Completion of Data Transmittal Form • Timely Submission of Image Data • Prompt Response to Data Clarification Form

  27. Bio-Imaging Responsibilities • Send Imaging Study Kit • Collect Image Data • Quality Control of Image Data • Follow-up on Image Data Clarifications • Analyzing/Reviewing Imaging Data • Export Analysis to Roche

  28. Contact Information Bio-Imaging Technologies, Inc. 826 Newtown-Yardley Road Newtown, PA 18940-1721 Tel: +1.267.757.3000 Tel: +1.800.748.9032 Fax: +1.267.757.1361 Bio-Imaging Supplies Tel: +1.267.757.3002 Fax: +1.267.757.1380 Email: supplies@bioimaging.com Web Address: www.bioimaging.com

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