Thesis on Training Methods for Managers

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					   Training Clinical Data Managers
A Joint Industry-Academic Perspective

                     Society for Clinical Trials
                       2007 Annual Meeting
                         Montreal, Canada
                      James R. Johnson, PhD
    Adjunct Professor of Clinical Research, Campbell University
Director-Planning and Documentation, BioCryst Pharmaceuticals, Inc.




Department of Clinical Research
     Questions and Objectives



     • How do we train Clinical Data Managers
       for work in Industry?
             – CROs
             – Pharmaceutical and Biotechnology Companies
             – Data Coordination Centers (Joint Academic-Industry
               Collaborations)

     • What are the essential elements of a
       training program?


14 November 2010                    Data Management Training Modules   Page 2
  Elements of Data Management Training Center with
          Good Data Management Practices

1.       Study Design
          Sets the ground work for establishing Good
                                                                                     1
           Data Management Practices
                                                                   STUDY DESIGN
2.       Study Methods
          Implementing data mgt practices consistent
           with ensuring that study methods are robust
           and accurately implemented. Concerned                                                   2
           primarily with Data Collection Methods, and
           validation of the data collection methodology.
                                                                                          STUDY
3.       Study Analysis                                                                  METHODS

          Poor data mgt practices leads to
           “questionable” study analysis, whereas solid
           data mgt methodology generally results in
           observations that are true to the experiment.                         4                                3
4.       Feedback Loop
                                                                                                        STUDY
          The Study Analysis serves to provide a check                                                ANALYSIS
           on the Original Study Design. Is an indicator
           of how well the design, data management,
           and statistical practices were established and
           implemented.


14 November 2010                              Data Management Training Modules                                    Page 3
   Where Does Good Data Management Practice fit
   into a Clinical Study? What training is essential?

                           Protocol Review
                           Data Dictionary Design
        STUDY DESIGN
                           CRF Design, Edit Specifications
                           Data Management Plan


                                                Data Entry
                                                Query Generation and Mgt.
                        STUDY                   Coding: AEs and Medications
                       METHODS
                                                Laboratory Data Management



                                                                     Medical and Statistical Review
                                      STUDY
                                                                     Database Auditing
                                     ANALYSIS                        Locking the Database
                                                                     Formal Planned Analysis
                                                                     Archiving
14 November 2010                  Data Management Training Modules                               Page 4
Goals and Objectives for training Clinical Data
Managers for work in Industry


     • Goals                                             • Objectives
             – To provide the Data Manager                        – To present principles of data
               with a comprehensive                                 management for:
               understanding of the principles                             • Study Design, Planning,
               of data management as a                                       Randomization, and Data
                                                                             Collection Methodology
               discipline.
                                                                           • Case Record Form Design
             – To provide practical skills that                            • Data Quality measures
               allow the data manager to take
                                                                           • Data Validation issues
               the principles presented and
               apply them across a wide array                              • Coding Dictionary Use/Abuse
               of clinical research projects.                              • Medical/Statistical review of
                                                                             trial data.
             – To provide Regulatory                                       • Closure/Archiving
               Compliant training for the Data
                                                                           • Good Data Management
               Manager to provide “data” that                                Practices & Guidelines
               may be used for submissions
14 November 2010                        Data Management Training Modules                                     Page 5
     Clinical Data Manager



     • Roles and responsibilities of a Clinical data
       Manager vary with the setting and scope of the
       Clinical Research Program. Some generalities do
       apply to a general role.
             – Who are these people?
             – What Roles and Responsibilities do they Assume?
             – How do they interact with other Clinical Trials
               Specialists (e.g. statisticians, CRAs, etc.)?
             – What kind of training and experiences do professional
               data managers need to be successful?
14 November 2010                 Data Management Training Modules      Page 6
Clinical Data Management: Roles and Responsibilities



     • Clinical Data Managers are Responsible for:
             – Providing strategic DM leadership and expertise to the clinical
               development team. (Protocol and CRF Development)
             – Proactive Communication with the Clinical Development Team for all
               Data Management Activities.
             – Manage DM activities (and partners) for adherence to project timelines.
             – Review and approve DM related documents.
             – Monitor Data Quality for adherence to GCP and defined quality
               standards.
             – Proactively monitor DM activities to provide continuous process
               improvement with data collection and processing methods.
             – Overall responsibility for delivering high quality, regulatory compliant
               clinical data bases for regulatory submissions and publication of study
               results.

14 November 2010                        Data Management Training Modules                  Page 7
     Clinical Data Management Responsibilities



     • Clinical Data Managers Manage Processes for:
             – Collection of appropriate study data, in line with study objectives and
               endpoints.
             – Efficient entry and cleaning of CRF data, minimizing unnecessary work.
             – Quality to provide maximum benefit of study data.


     • Note the manuscript presenting the thesis
       regarding the statisticians active role in DM
       process.
             – Grobler AC, Harris SL, Jooste HL. The role of the statistician in the data
               management process. Drug Information Journal 2001;35:665-670

14 November 2010                          Data Management Training Modules                  Page 8
     Clinical Data Management: Responsibilities


     • Clinical Data Managers Tasks May Include:
             – Case Record Form Development
             – Data Base Design and Setup.
             – Data Entry and Verification.
             – Edit Specification Programming.
             – Query Generation and Resolutions.
             – Data Base Corrections and Audit Trails.
             – Integration of external data sets (e.g. clinical laboratory investigations, imaging
               data, ECG data)
             – Medical Coding (MEDRA), Rx Coding (WHOMED).
             – Data Base Quality Control.
             – Data Base Auditing.
             – Electronic Delivery of study data sets for interim monitoring and medical review.
             – Delivery and Archiving of of Final Study Data Sets.


14 November 2010                              Data Management Training Modules                       Page 9
  Clinical Data Management: Training and Experiences


     • Clinical Data Manager Training & Experience
       Includes:
             – Educational Background in the Life Sciences (Biology, Medicine,
               Biochemistry, etc.).
             – Training and Understanding in Clinical/Medical Terminology
             – Working knowledge of clinical databases (relational database
               technology), and appropriate programming functions.
             – Superior communications (oral and written) skills, and the ability to work
               collaboratively on cross-functional clinical development teams.
             – Must be highly detailed oriented, with experience reviewing and solving
               complex interdependent data-relationships and problems.
             – Very Flexible, Adaptable, and Resilient to the evolving environment of
               DM technology, and best data management practices.
             – Good Project Management Skills

14 November 2010                        Data Management Training Modules                 Page 10
Study Design:
Training the Data Managers to Ask Questions!

     • At Study Design the concept of rational CDM practices must be
       started.
     • Critical Data Management questions that must be address at the
       conception of a Research Protocol.
             – What is the “Clear” Objective of the study?
             – What is the Target Variable(s) to be assessed in the study?
             – How are the Target Variable(s) measured?
             – Can Target Variable measurements be reproduced and validated.
             – Are the Target Variables:
                   • Objective Assessments by an Independent Assessor or
                     Instrument?
                   • Subject Assessments supplied by the Subject or Observation?

14 November 2010                       Data Management Training Modules            Page 11
     Training Data Managers to utilize “standards”
     Key Identifiers Critical to Data Management

     • Key Identifiers
             – Protocol
             – Investigator
             – Site (if applicable)
             – Subject
             – Visit
             – Random Code (Treatment ID)
     • The unique combination of these identifiers allows for identification
       of a subject, at a point in time, with the planned treatment
       assignment.
     • No two identifiers are identical for any given subject.



14 November 2010                      Data Management Training Modules         Page 12
  Training Data Managers to utilize “standards”
  Principles of CRF Design


     • Key Principles for developing a paper
       based Case Record Form.
             – Follow the principles of K.I.S.S. (Keep it Simple for Silly People!)
             – Use Standard Headers for Key Attributes
             – Put important data collection date/time in the Top of the form.
             – Never Mix data collection unless absolutely necessary

     • Similar principles apply for training on the
       use of electronic data capture methods.

14 November 2010                          Data Management Training Modules            Page 13
     Training Data Managers
     Quality Data Management as a Discipline




14 November 2010        Data Management Training Modules   Page 14
     Elements of a Quality Management System
     for Clinical Data Management

     • Documented
             – Roles and Responsibilities of Data Managers
             – CV (Resume) and Training Records Demonstrating Competency
               for specified Role and Responsibility.
             – Standard Operating Procedures (SOP): Organizational and
               Departmental
             – Data Management Departmental Level Handbook of Policies and
               Procedures.
             – Operating Manuals (OM), sometimes called Working Practices
               (WP), for each “Major” Function identified in an SOP.
             – Clearly Defined and Documented Procedures for document
               development, review, and approval.

14 November 2010                     Data Management Training Modules        Page 15
     Training Data Managers:
     Quality Implementation through SOPs

     • Roles & Responsibilities:                                             • Corresponding SOP (WP):
             –     Case Record Form Development                                       –    SOP 1.04.04-01
             –     Data Base Design and Setup.                                        –    SOP 1.04.05-02 (WP 1.04.05-02)
                                                                                      –    SOP 1.04.06-03
             –     Data Entry and Verification.
                                                                                      –    SOP 1.04.07-01 (WP 1.04.07-01)
             –     Edit Specification Programming.
                                                                                      –    SOP 1.04.08-12
             –     Query Generation and Resolutions.
                                                                                      –    SOP 1.04.09-07
             –     Data Base Corrections and Audit Trails.
                                                                                      –    SOP 1.04.10.09
             –     Integration of external data sets.
                                                                                      –    SOP 1.04.11.04
             –     Medical Coding (MEDRA),                                            –    SOP 1.04.11.02
             –     Rx Coding (WHOMED).                                                –    SOP 1.04.12.07
             –     Data Base Quality Control.                                         –    SOP 1.04.13.02
             –     Data Base Auditing.                                                –    SOP 1.04.14.02
             –     Data Base Monitoring & medical review.                             –    SOP 1.04.15.09
             –     Database Locking and Approval                                      –    SOP 1.04.16.18
             –     Delivery and Archiving of Final Study                              –    SOP 1.04.17.02
                   Data Sets.

14 November 2010                                        Data Management Training Modules                                    Page 16
     Training Data Managers
     Project Specific Data Management Plan


     • Outlines the specific elements to be completed for
       a project.
     • Is the basis for establishing Data Quality &
       acceptance at the project level.
     • Identifies any and all expected deviations from
       SOPs or WPs for the project.


     • Remember If is ain’t written down it did not
       happen!!
14 November 2010          Data Management Training Modules   Page 17
Training Data Managers:
CT Information Platforms: RDBMS & Data Warehouses


                                                  Clinical Portals
                                                                                               Study
                   Paper      EDC        Labs     Images                 Site Mgt       PV                Reporting
                                                                                               Setup
                           Clinical Acquisition                                   Clinical Intelligence
                               Applications                                           Applications


                           Clinical Acquisition                                   Clinical Intelligence
                               Framework                                              Framework
                                                                           Data        Data     Data       Data
               RDBMS          Safety    Metadata Dictionary                Marts       Marts    Marts      Marts



                                       Clinical Trials Data Warehouse


14 November 2010                                    Data Management Training Modules                                  Page 18
     Training Data Managers:
     Relational Database Design Principles


     • Relational     PROTOCOL


       Database
       Design               INVESTIGATORS


       Principles
                                                    SITES




                                                            SUBJECTS

                             ONE


                                                                       VISITS



                          TO MANY
                                                        TREATMENTS              ASSESSMENTS



14 November 2010         Data Management Training Modules                                     Page 19
     Training Data Managers:
     Medical and Statistical Review Principles

                                                             Biostatistics and               Statisticians
                                                                                             Statistical Programmers
          Medical and Statistical Review Audiences




                                                              Data Sciences                  Data Managers


                                                           Clinical Research and             Study Physicians (M.D.’s)
                                                                                             Clinical Research Scientists (PharmD, Ph.D., MPH, RN’s, etc)
                                                     1o        Medical Affairs               Clinical Trial Managers (Operational Positions)


                                                                                             Writer’s (CSR or Manuscripts: M.D.’s, PharmD, Ph.D. BS, MS, MPH,
                                                          Medical Communications             RN’s, etc.)



                                                                                             Regulatory Directors and Managers (M.D.’s, PharmD, Ph.D. BS, MS,
                                                             Regulatory Affairs              MPH, RN’s, etc.)



                                                           Clinical Pharmacology
                                                     2o    and Pharmacokinetics
                                                                                             Pharmacology Scientists (PharmD, Ph.D.)



                                                              Marketing and                  Market Planners
                                                             Market Research                 Market Research Scientists




                                                                                             Statisticians (Internal and External Consultants)
                                                           Regulatory Agencies               Medical Reviewers (M.D.’s)
                                                                                             Project Managers

14 November 2010                                                           Data Management Training Modules                                                     Page 20
Training Data Managers to Begin with the End in Mind


• Patient Disposition                                    INFORMED CONSENT / SCREENED
                                                                   (N=XXX)

  Figure in all                                                                              SCREEN FAILURES
                                                                                                 (N=XXX)
  Study Reports
                                                                    RANDOMIZED
  (ICH E3)                                                            (N=XXX)


  (CONSORT)                                                                                    WITHDRAWLS
                                                                                                 (N=XXX)


                   SAFETY POPULATION                          FULL ANALYSIS SET (ITT)
                        (N=XXX)                                      (N=XXX)


                                                                                        MAJOR PROTOCOL VIOLATIONS
                                                                                                 (N=XXX)
                   SAFETY SUBGROUP(S)
                         (N=XXX)
                                                                PER-PROTOCOL(PP)
                                                                     (N=XXX)




                                                              EFFICACY SUBGROUP(S)
                                                                     (N=XXX)


14 November 2010                        Data Management Training Modules                                            Page 21
     Advanced Data Management Course Syllabus
     (10-12 Weeks: Principles and Practices)

     • Overview, Definitions, Data Types,
     • Roles and Responsibilities of Data Mgt in CR
     • Study Design, Data Management Planning, Randomization Principles,
     • Data Collection Methodologies
     • Processes and Procedures for Addressing Data Quality, SOPs and Working
       Practices.
     • Data Validation: Systematic Error, Controlling for Biases, Edit Specifications
     • Data Base Management Systems
     • Form and Function of Coding Dictionaries
     • Electronic Data Capture: Clinical Laboratory Investigations
     • Medical and Statistical Review of Study Data
     • Data Base Closure, Reporting, and Archiving
     • Communication Strategies: Oral and Written
     • Computer Skills: Programming and RDBMS utilization
14 November 2010                     Data Management Training Modules                   Page 22
     Questions




14 November 2010   Data Management Training Modules   Page 23

				
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