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PRIMA Investigator‘s Meeting Protocol MO18264 ASH 2006 Bio-Imaging Technologies, Inc. December 9 th , 2006 PowerPoint PPT 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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Slide 1 1324038

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


Slide 1 1324038

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


Slide 1 1324038

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.


Slide 1 1324038

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


Slide 1 1324038

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: [email protected]

Web Address:

www.bioimaging.com


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