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PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9 th , 2006 PowerPoint Presentation
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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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Presentation Transcript
slide1

PRIMA Investigator‘s Meeting

Protocol MO18264

ASH 2006

Bio-Imaging Technologies, Inc.

December 9th, 2006

agenda
Agenda
  • Bio-Imaging Overview
  • Role of Bio-Imaging
  • Imaging Requirements
  • Bio-Imaging Responsibilities
  • Site Responsibilities
bio imaging overview
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
slide4

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
study mo18264 prima
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.
imaging requirements
Imaging Requirements
  • Timepoints
    • Baseline
    • Induction
    • Maintenance
    • End of Treatment
    • Follow-up
  • Anatomical Region
    • Chest, Abdomen, Pelvis
imaging requirements1
Imaging Requirements
  • Scans Must be Performed Consistently Between All Timepoints to Assess Endpoints
  • Same Scanner & Technique Must be Used Throughout the Trial
retrospective data collection
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
retrospective data transmittal forms rdtf
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.
image submission procedure retrospective
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
imaging study kit
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
imaging guidelines
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
image submission procedure prospective
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
slide14

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.
slide15

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
image data flow
Image Data Flow

Initial QC

Transmit

Log/Track

Digitize or

Translate

Site

Independent Review

Site

Preparation

&

Standardization

Image QC & Archival

data transmittal form
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
media
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
courier waybills
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
central image collection
Central Image Collection
  • Data Collection
    • Coordinate
    • Log and Track
  • Initial QC of Image Data
    • Preliminary Check
    • Image Data Clarifications
  • Image Data Tracking
image qa qc review
Image QA/QC Review
  • Performed by Radiology Technologist
  • Protocol Compliance
  • Technical Adequacy
  • Rapid Review Process
    • Detect Problems Early
    • Prevent Backend Delays
communication to sites on quality
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
image data clarification form
Image Data Clarification Form
  • Generated by Bio-Imaging
  • Requires a Site Response
  • Must be Returned within 1 Week of Issuance of Original DCF Form
reasons for queries
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)
how to ensure quality at your site
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
site responsibilities
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
bio imaging responsibilities
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
slide28

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