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The FDA Guidance of a Risk-Based Approach
                            to Monitoring as Viewed By CDM
                                        William Gluck, Ph.D.
                                VP, Clinical and Consulting Services




8 February 2013
Disclaimer
      ►    The views and opinions expressed in the following PowerPoint
           slides are those of the individual presenter and should not be
           attributed to Drug Information Association, Inc. (“DIA”), its
           directors, officers, employees, volunteers, members, chapters,
           councils, Special Interest Area Communities or affiliates, or any
           organization with which the presenter is employed or affiliated.
      ►    These PowerPoint slides are the intellectual property of the
           individual presenter and are protected under the copyright laws of
           the United States of America and other countries. Used by
           permission. All rights reserved. Drug Information Association, Drug
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           trademarks. All other trademarks are the property of their
           respective owners.

            16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
            February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 2
Agenda

       ►  HistoricalPerspectives in CDM
       ►  Overview of the Draft Guidance

       ►  A Risked-Based Approach

       ►  Challenges to a Risk-Based Approach

       ►  Supporting a Risked-Based Approach

       ►  Summary



                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Historical Perspectives in CDM
       ►  Drug          development process
                  •  Paper-based processing


       ► Electronic          Data Capture
                  • Interactive processing
                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Historical Perspectives in CDM

       Age of technological advances
         •  Application of technology
            to a process: introducing
            risk
         •  Integration of technology
            as part of a risk-based
            approach
                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
FDA Draft Guidance
       ►  Risk-Based  monitoring
       ►  1988 guidance withdrawn

       ►  Centralized (off-site) monitoring is
          encouraged and suggested to replace on-site
          monitoring when it can complete activities
          better or as well as on-site


                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
FDA Draft Guidance

      ► Well-defined   risk-based monitoring plan
           could improve the quality and integrity
           of data
             • Publications suggest that data anomalies
                   may be more readily detected
      ► Integrating   technology appropriately to
           support a risk-based approach can
           enable decreased reliance on on-site
           monitoring (reduced cost)
            16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
            February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 7
A Risk-Based Approach

       ►  Protocol  – Key Challenge
       ►  Developing strategies/plans to implement
          centralized monitoring
       ►  Enabling the Risked-Based Approach:
          Process Integration
       ►  Supporting the Risked-Based Approach



                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Challenges to a Risk-Based Approach


       “The most important tool for ensuring
       human subject protection and high-quality
       data is a well-designed and articulated
       protocol.”




                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Challenges to a Risk-Based Approach

      Guidance intends to assist in developing risk-
      based monitoring strategies/planning
              •  Tailored to subject protection and data integrity
              •  Focuses on critical study parameters
              •  Encourages use of a combination of monitoring activities
              •  Encourages greater reliance on centralized monitoring
                    practices, where appropriate




             16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
             February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 10
Challenges to a Risk-Based Approach

      Well-Defined Monitoring Plans:
              •  Description of monitoring approaches (e.g., timing,
                    intensity, activities, documentation) – Targeted SDV
              •     Communication of monitoring results
              •     Management of noncompliance
              •     Training and study-specific information
              •     Monitoring plan amendments




             16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
             February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 11
Process Integration Enables the Risk-
                     Based Approach
       Key Processes must be integrated:
                  •  Data Collection, Cleaning, Monitoring
                         – eCRF design (including protocol deviations and
                           edit checks) require both Clinical Operations
                           and CDM
                         – Query process is interactive/optimized
                           between Clinical Operations and CDM
                         – Dynamic monitoring-Real time data sharing
                           between Clinical Operations and CDM
                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Supporting the Risked-Based Approach

       CDM plays a critical role
       Technologically there are few challenges
       Process/Workflow Flow – KEY!
       Specific strategies to reduce risk
                         Focus on data quality/integrity
                         Define and share study metrics
                         Enhance training and communication

                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Data Quality/Integrity
       ► Identify                       critical study data and processes
                  •  Endpoints
                  •  Serious Adverse Events
                  •  Randomization/ Blinding
                  •  Consent
                  •  Eligibility Criteria
                  •  Risks specific to protocol design and conduct



                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Define and Share Study Metrics

      Provide performance metrics
      Monitor data quality
                     Identify higher risk sites
      Support 100%, partial, and remote SDV
      Dynamic analysis of data - identify trends
      Provide analysis to evaluate specific subject
      data – especially outliers
             16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
             February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 15
Enhance Quality with Technology

      Provide multiple training options:
                     Face-to-Face Training
                     Virtual Interactive Training
                     Multimedia e-Training




             16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
             February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 16
Summary
           ►  Draft  guidance acknowledges that changes
              to monitoring are OK
           ►  A risked-based approach does not eliminate
              risk – there is a balance of risk and benefit
           ►  CDM plays a key role in supporting risked-
              based monitoring and ensuring data quality



                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –
Selected References
      Guidance for industry: Guideline for the Monitoring of Clinical Investigations, January 1988

      Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
      http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf

      CPGM 7348.810: Sponsors, Contract Research Organizations and Monitors (March 22, 2011), available at:
      http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133777.htm

      CPGM 7348.811: Clinical Investigators and Sponsor-Investigators (December 8, 2008), available at:
      http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm

      Collins, Rory. (2010, October) Quality Design of Clinical Trials. Presentation at CTTI work stream 3 expert meeting.
      https://www.trialstransformation.org/projects/effective-and-efficient-monitoring/developing-effective-quality-systems-in-clinical-
      trials-an-enlightened-approach

      FDA guidance documents regarding electronic records and signatures subject to 21 CFR part 11
      http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126953.pdf and the use of computerized systems in clinical
      investigations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf

      Two studies are on-going as of December 2010 that compare the effectiveness of on-site to alternative (e.g., centralized)
      monitoring methods - OPTIMON study: https://ssl2.isped.u-bordeaux2.fr/optimon/Default.aspx
      and ADAMON study: http://ctj.sagepub.com/content/early/2009/11/06/1740774509347398.full.pdf
             16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
             February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential – 18
William Gluck, Ph.D.
        VP, DATATRAK Clinical and Consulting Services
                 DATATRAK International
               E-Mail: Bill.Gluck@datatrak.net

                 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM
                 February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan
Confidential –

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The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDM

  • 1. The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDM William Gluck, Ph.D. VP, Clinical and Consulting Services 8 February 2013
  • 2. Disclaimer ►  The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. ►  These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 2
  • 3. Agenda ►  HistoricalPerspectives in CDM ►  Overview of the Draft Guidance ►  A Risked-Based Approach ►  Challenges to a Risk-Based Approach ►  Supporting a Risked-Based Approach ►  Summary 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 4. Historical Perspectives in CDM ►  Drug development process •  Paper-based processing ► Electronic Data Capture • Interactive processing 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 5. Historical Perspectives in CDM Age of technological advances •  Application of technology to a process: introducing risk •  Integration of technology as part of a risk-based approach 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 6. FDA Draft Guidance ►  Risk-Based monitoring ►  1988 guidance withdrawn ►  Centralized (off-site) monitoring is encouraged and suggested to replace on-site monitoring when it can complete activities better or as well as on-site 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 7. FDA Draft Guidance ► Well-defined risk-based monitoring plan could improve the quality and integrity of data • Publications suggest that data anomalies may be more readily detected ► Integrating technology appropriately to support a risk-based approach can enable decreased reliance on on-site monitoring (reduced cost) 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 7
  • 8. A Risk-Based Approach ►  Protocol – Key Challenge ►  Developing strategies/plans to implement centralized monitoring ►  Enabling the Risked-Based Approach: Process Integration ►  Supporting the Risked-Based Approach 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 9. Challenges to a Risk-Based Approach “The most important tool for ensuring human subject protection and high-quality data is a well-designed and articulated protocol.” 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 10. Challenges to a Risk-Based Approach Guidance intends to assist in developing risk- based monitoring strategies/planning •  Tailored to subject protection and data integrity •  Focuses on critical study parameters •  Encourages use of a combination of monitoring activities •  Encourages greater reliance on centralized monitoring practices, where appropriate 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 10
  • 11. Challenges to a Risk-Based Approach Well-Defined Monitoring Plans: •  Description of monitoring approaches (e.g., timing, intensity, activities, documentation) – Targeted SDV •  Communication of monitoring results •  Management of noncompliance •  Training and study-specific information •  Monitoring plan amendments 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 11
  • 12. Process Integration Enables the Risk- Based Approach Key Processes must be integrated: •  Data Collection, Cleaning, Monitoring – eCRF design (including protocol deviations and edit checks) require both Clinical Operations and CDM – Query process is interactive/optimized between Clinical Operations and CDM – Dynamic monitoring-Real time data sharing between Clinical Operations and CDM 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 13. Supporting the Risked-Based Approach CDM plays a critical role Technologically there are few challenges Process/Workflow Flow – KEY! Specific strategies to reduce risk Focus on data quality/integrity Define and share study metrics Enhance training and communication 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 14. Data Quality/Integrity ► Identify critical study data and processes •  Endpoints •  Serious Adverse Events •  Randomization/ Blinding •  Consent •  Eligibility Criteria •  Risks specific to protocol design and conduct 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 15. Define and Share Study Metrics Provide performance metrics Monitor data quality Identify higher risk sites Support 100%, partial, and remote SDV Dynamic analysis of data - identify trends Provide analysis to evaluate specific subject data – especially outliers 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 15
  • 16. Enhance Quality with Technology Provide multiple training options: Face-to-Face Training Virtual Interactive Training Multimedia e-Training 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 16
  • 17. Summary ►  Draft guidance acknowledges that changes to monitoring are OK ►  A risked-based approach does not eliminate risk – there is a balance of risk and benefit ►  CDM plays a key role in supporting risked- based monitoring and ensuring data quality 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –
  • 18. Selected References Guidance for industry: Guideline for the Monitoring of Clinical Investigations, January 1988 Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf CPGM 7348.810: Sponsors, Contract Research Organizations and Monitors (March 22, 2011), available at: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133777.htm CPGM 7348.811: Clinical Investigators and Sponsor-Investigators (December 8, 2008), available at: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm Collins, Rory. (2010, October) Quality Design of Clinical Trials. Presentation at CTTI work stream 3 expert meeting. https://www.trialstransformation.org/projects/effective-and-efficient-monitoring/developing-effective-quality-systems-in-clinical- trials-an-enlightened-approach FDA guidance documents regarding electronic records and signatures subject to 21 CFR part 11 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126953.pdf and the use of computerized systems in clinical investigations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf Two studies are on-going as of December 2010 that compare the effectiveness of on-site to alternative (e.g., centralized) monitoring methods - OPTIMON study: https://ssl2.isped.u-bordeaux2.fr/optimon/Default.aspx and ADAMON study: http://ctj.sagepub.com/content/early/2009/11/06/1740774509347398.full.pdf 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential – 18
  • 19. William Gluck, Ph.D. VP, DATATRAK Clinical and Consulting Services DATATRAK International E-Mail: Bill.Gluck@datatrak.net 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, Japan Confidential –