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					Moving Up Higher:
Taking GCP Training To A New Level




David Millard
Associate Director, Pfizer

Ruth Ann Nylen, PhD
Lead Consultant, The RAN Institute

                                     1
Pharmaceutical Research And Manufacturer’s
Industry Perspective




David Millard
Associate Director
Pfizer




                                             2
Numbers



                       880,000,000 to 1.3 billion

                   Cost of Rx development in dollars

                                10,400

 Number of clinical trials sponsored by NIH, industry and other Federal
                         agencies in clinicaltrial.gov

                                 50
                  Number of states studies conducted
                                                                          3
Numbers


                           90
            Number of countries clincaltrial.gov

                          41,000
 Number of active, government and industry listing noted by
                        Center Watch




                                                              4
Imagine!



      • There were no guidelines
      • There was no training
      • What would be the state of Rx development?



           MOST IMPORTANT!

      • What would be the state of subjects/patients
        participating in clinical trials?

                                                       5
Keep Focused




   Compliance with ICH/GCP provides public
   assurance that the rights, safety, and well
   being of trial subjects are protected consistent
   with the principles…of the Declaration of
   Helsinki …


                                                      6
The International Conference on Harmonization (ICH)
Guidelines




    GCP is an international ethical and scientific
    quality standard for designing, conducting, and
    recording trials that involve human subjects

           • Safety
           • Quality
           • Efficacy

                                                      7
Key Principles of ICH




    •   Ethical principles of the Declaration of Helsinki
    •   Benefit of the individual (benefits justify risk)
    •   Protection of individuals prevail
    •   Adequate drug data to support clinical trial
    •   Clinical trials should be scientifically sound
    •   IRB/IEC approvable / favorable opinion
    •   Subject care is under a qualified physician

                                                            8
Key Principles of ICH – Cont’d




     •   Staff is qualified, educated, experienced & trained
     •   Obtain freely given informed consent
     •   Data accuracy
     •   Confidentiality of records
     •   Good manufacturing practice
     •   Quality systems implemented


                                                               9
Guidance




     Responsibilities, procedures, records & reports

        •   IRB / IEC
        •   Investigator
        •   Sponsor
        •   Protocol
        •   Investigator’s Brochure
        •   Essential Documents

                                                       10
Raise The Bar




 The bar must be raised on ICH/GCP training to account for
   US and global changes in the following:

    • US / Global Healthcare Industry
    • Pharmaceutical Research and Manufactures Industry
    • Regulatory Oversight



                                                             11
Brief Overview of Significant Changes in US/Global
Healthcare

      • USA
                       – Free market driven with emphasis on managed care

      • EU/CAN
                       – Government cost containment & controlled access

      • Average lifespan of an American increased by nearly
        30 years since 1900 ¹

      • More patients are using more medicines
                       – Health care is shifting from older forms of care, such as hosp.
                         to newer technologies, such as pharmaceuticals. ²

                                                                                                                                       12


 ¹ Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmaceutical Industry Profile 2003 (Washington, D.C.).
 ² J. D. Kleinke, “The Price of Progress: Prescription Drugs in the Health Care Market,” Health Affairs 20 (Sept/Oct 2001): 5, 43-60
US Health Care Dollar: 2001




                          $0.23
                          $0.22                                                         Hospital Care
                                              $0.32                                     Other
                                                                                        Admin. & Net Costs
                 $0.10
                                                                                        Nursing Homes
                                                                                        Rx Drugs
                  $0.07                  $0.23                                          Physician Services
                       $0.06




                                                                                                             13


     Source: Centers for Medicare & Medicaid Services, “The nation’s Health Dollar: 2001,” 8 January 2003
     http://cms.hhs.gov/statistics/nhe/historical/chart.asp (21 January 2003
USA Healthcare Increased Use of Medicines




                        20 %
                                                  29 %                            Price Inflation

                                                                                  Increased Use of Existing Rxs


                               51 %                                               Added Use of New Medicines




                                                                                                                  14



  Source: IMS Health’s custom analysis based on Retail and Provider Perspective ™ data 2002
Brief Overview of Significant Changes in US/Global
Healthcare

Pharmaceutical advances in science and treatment
          Disease/Illness                                                              New Rx in Development
             •   Cancer                                                                                    402
             •   Heart Disease & Stroke                                                                    123
             •   HIV/AIDS (Rx & vaccines)                                                                   83
             •   Pain                                                                                       41
             •   Alzheimer’s                                                                                24
             •   Brain Tumors                                                                               24
             •   Multiple Sclerosis                                                                         16
             •   Parkinson’s                                                                                16
             •   Stroke                                                                                     14
             •   Migraine                                                                                   10
             •   Epilepsy                                                                                    9            15



  Pharmaceutical Research and Manufactures of America (PhRMA), Pharmaceutical Industry Profile 2003 (Washington, D.C.).
Current Pharmaceutical Research and
Manufacture Industry


 • Active consolidation via mergers and acquisitions
 • Concept to market = 15 yrs
 • Total R&D expenditures $32 billion
       – Approximately 20% of Sales
          ٠ 81.5 % Domestic
          ٠ 17.5 % Abroad
          ٠ 1.0 % Veterinary
 • Cost of Rx development ranges $880 million to $1.3 billion

                                                                                                                          16



  Pharmaceutical Research and Manufactures of America (PhRMA), Pharmaceutical Industry Profile 2003 (Washington, D.C.).
R&D PhRMA Members 2001
Domestic R&D By Function




                                    Dollar Figures In Millions

 Function                                         Dollars        Share
 Preclinical                                      $ 9,647.4      32.0%
 Phase I                                          $ 1,659.2      5.6%
 Phase II                                         $ 3,151.2      10.6%
 Phase III                                        $ 4,502.2      15.1%
 Approval                                         $ 2,307.9       7.8%
 Phase IV                                         $ 3,286.9      11.1%
 Uncategorized                                    $ 5,167.9      17.4%
 Grand Total                                      $29,722.7      100.0%
                                                                          17



   Source: PhRMA Annual Membership Survey, 2003
R&D PhRMA Members 2001
Domestic R&D Personnel By Function




Function                                           Personnel    Share
Preclinical                                         28,159      40.0%
Phase I                                              5,338       7.6%
Phase II                                             7,633      10.9%
Phase III                                           15,492      22.1%
Approval                                             3,048       4.4%
Phase IV                                             6,386       9.1%
Uncategorized                                          529       0.8%
Total R&D Staff                                     66,585      95.1%

Supported R&D Non-staff                              3,407       4.9%
Grand Total                                         69,992     100.0%   18



    Source: PhRMA Annual Membership Survey, 2003
Status of Clinical Trials




 • Increase in need of experienced investigators
 • Studies require 20% more procedures than previously
 • 41,000 clinical trials around world by gov, pvt., industry
   and health agencies *
 • Clinical trials are being conducted on a global scale
 • Subject recruitment is becoming increasingly difficult and
   competitive.


                                                                19



   *Source: Centerwatch web site
Pharmaceutical Research and Manufacture Industry



    Public Perception & Opinion
    Intense scrutiny!
    • Media
    • Patient Advocacy Groups
    • State & Local Governments
    • Employers
    • Insurers


                                                   20
Trends in Regulatory Process



  • Increasing surveillance and regulatory oversight
    emerged over the past 25 years
  • FDA employs comprehensive program for on-site
    inspections and data audits
  • Inspections of US Sites & sponsors by non-US regulatory
    agencies
  • Premarket requirements become more stringent
  • Greater emphasis on training methods and programs.

                                                              21
Case Studies



 FDA lists
   • Review significant observations
   • Review summary of findings and recommendations
   • Discuss merits and training needs to address each case.
       – What would you do for training?
   • Summarize Approximate Return on Investment
       – Positive
       – Negative

                                                               22
Case Study 1
Significant Observations


Failure

   1. The general responsibilities of investigators (21 CFR
      312.60 and Part 50)
                – Personally conduct or supervise the study
                – Signed and dated source docs. & consent forms when absent
                – Provide names of all sub-inv.to the sponsor

   2. Failure to prepare and maintain complete and accurate
      case histories (21 CFR 321.62 (b))
                – No source docs. avail. for screen. & physicals

                                                                                   23



   FDA Warning Letter Form FDA 483: Nov 30 2000 Dr. A. Buchman, M.D. Chicago, IL
Case Study 1
Summary



• Serious failure to fulfill responsibilities as P.I including
  supervision of personnel.
• Staff were not adequately credentialed, trained, or
  monitored.
• Authority may be delegated, but P.I is responsible.
• Recommend completion of a course in GCP


                                                                                   24



   FDA Warning Letter Form FDA 483: Nov 30 2000 Dr. A. Buchman, M.D. Chicago, IL
 Case Study 2
 Significant Observations

Failure
   1. Conducted according to the signed investigational plan
       (protocol). (21 CFR 312.60)
         •      Subject eligibility (I/E criteria) deviations.
         •      Study procedures deviations
         •      Study Drug Storage deviations
   2. Prepare and maintain adequate and accurate case
      histories and other data pertinent to the investigation.
      (21 CFR 312.62(b))
         •      Records disorganized with source doc. Discrepancies
         •      Concomitant Rx(s) not noted
         •      AE(s) but not in CRF
                                                                                         25
   3. Notify IRB of serious AE(s). (21 CFR 312.66)
   FDA Warning Letter Form FDA 483: Jun 20 2000, Dr. H. Terebelo, D.O., Southfield. MI
Case Study 2
Summary


• Form FDA 1572

• Lack of understanding of procedures and requirements

• “All personnel assisting in the conduct of a clinical study
  should be trained in GCP”

• Meet periodically with the team

• Responsible for supervising the study coordinator and other
  assistants

                                                                                         26



   FDA Warning Letter Form FDA 483: Jun 20 2000, Dr. H. Terebelo, D.O., Southfield. MI
  Case Study 3
  Significant Observations

Failure
   1. Report unanticipated adverse device effects or deaths in a
        timely manner to the reviewing IRB. CFR 812.150(a)(1)
          •       AE(s) to IRB within required time period


   2. Obtain approval before allowing any subjects to
      participate. (21 CFR 812.110 (a))
          •       No IRB approval and IRB continuing review approval


   3.      Failure to conduct the study in accordance with the
           investigational plan. (21 CFR 812.100 and 812.110(b))
                                                                                                                 27
          •       Perform protocol required procedures

        FDA Warning Letter Form FDA 483: June 19, 2003, F. Criado, M.D., Baltimore, MD Union Memorial Hospital
Case Study 3
Response To Warning Letter



Request that the response be posted on the web site with
  warning letter. (excerpts)

   • “The research staff has received extensive training in IRB policies
     and procedures as well as FDA regulations. Sources of
     information have included the FDA auditor, IRB representatives,
     as well as staff attendance of a recent FDA-sponsored symposium
     by the Society of Clinical Research Associates.”

   • Coordinator terminated



                                                                                                                                   28



   Response to FDA warning letter Form FDA 483 issued June 19, 2003, F. Criado, M.D. by Union Memorial Hospital, Baltimore, M.D.
Case Study 4
Significant Observations

Failure
     1. General responsibilities of investigators.
        (21 CFR312.6)
            •      Protect the rights, safety and welfare of subjects

      2. Investigation is conducted according to the
         investigational plan (protocol). (21 CFR 312.60)
            •      Changed investigational drug w/o approval


      3. Obtain informed consent in accordance with the
         provisions of 21 CFR Part 50. (21 CFR 312.60)
            •      Lacked required elements
                                                                                       29
            •      Waives subject’s legal rights

   FDA Warning Letter Form FDA 483: Jan 16, 2002, R. Hardaway III, M.D., El Paso, TX
Case Study 4
Significant Observations


Failure (Cont’d)

     4. Prepare and maintain adequate and accurate case
        histories and other data pertinent to the investigation.
        (21 CFR 312.62(b))
          •       Source doc. deficiencies


     5. Retain records pertinent to the investigation.
        (21 CFR 312.57 (C) & 12.62 (C)
          •       Missing documents

                                                                                       30



   FDA Warning Letter Form FDA 483: Jan 16, 2002, R. Hardaway III, M.D., El Paso, TX
Case Study 4
Summary




     “ We recommend that you undergo training in the
     responsibilities of sponsor and clinical investigators
     under 21 CFR before you initiate any new clinical
     study. Good Clinical Practice (GCP) is essential to
     maintain the quality of data collection regarding
     the conduct of clinical trials.”



                                                                                      31



  FDA Warning Letter Form FDA 483: Jan 16, 2002, R. Hardaway III, M.D., El Paso, TX
Case Study 5
Significant Observations

Failure

    1. Investigation is conducted according to the
       investigational plan (protocol). (21 CFR 312.60)
          •      Dosage deviations
          •      I/E criteria violations


    2. Maintain adequate records of disposition of the test
       article. (21 CFR 312.62(a))
       . Inaccurate Rx acct. records

                                                                                 32



   FDA Warning Letter Form FDA 483: JUN 21, 2000, E. Kopp, M.D., Raleigh, N.C.
Case Study 5
Significant Observations

Failure (Cont’d)

    3. Prepare and maintain adequate and accurate case
       histories (21 CFR 312.62(b))
          •      Source doc. deficiencies


    4. General responsibilities of investigators. (21 CFR
       312.60)
          “Please provide us with assurance that all study personnel, including
          the study coordinator(s) and sub-investigators, are trained in good clinical
          practices.”
                                                                                         33



   FDA Warning Letter Form FDA 483: JUN 21, 2000, E. Kopp, M.D., Raleigh, N.C.
Case Study 5
Summary



 •         Deviations in the conduct of the study appear to be the result of
           …lack of understanding of the procedures and requirements
           that govern the use of investigational new drugs

 •         Signature on Form FDA 1572, Statement of Investigator,
           indicates your agreement to comply with all requirements
           regarding the obligations for clinical investigators…

 •         …Non-compliance with the regulations governing the use of
           investigational drugs could affect not only the acceptability of
           the trial data but the safety of the human subjects of research.
                                                                                   34



     FDA Warning Letter Form FDA 483: JUN 21, 2000, E. Kopp, M.D., Raleigh, N.C.
Case Study 6
Significant Observations

Failure

    1. Investigation is conducted according to the
       investigational plan (protocol). (21 CFR 312.60)
          •      Protocol requirement to stop the study
          •      I/E criteria violation


    2. Report to the IRB unanticipated problems regarding
       the safety of the study. (CFR 21 312.66)
          •      AE(s) not reported to IRB
          •      FDA required the addition of a subject to the 4th dose cohort
          •      Protect the rights, safety and welfare of subjects
                                                                                     35



   FDA Warning Letter Form FDA 483: Nov 30, 2000, S. Raper, M.D., Philadelphia, PA
Case Study 6
Significant Observations

Failure (Cont’d)
    3. Report changes in the research activity to the IRB and
       made changes in the research without IRB approval.
       (21 CFR 312.66)
          •      Omitted significant protocol changes

    4. Obtain informed consent in accordance with the
       provisions of 21 CFR Part 50. (21 CFR 312.60)
          •      ICF was not amended; IRB approved ICF was not used

    5. Prepare and maintain adequate and accurate case
       histories of individuals treated with investigational
       drugs. (21 CFR 312.62)
                                                                                     36
          •      Source lab documents not maintained


   FDA Warning Letter Form FDA 483: Nov 30, 2000, S. Raper, M.D., Philadelphia, PA
Case Study 6
Summary




•     Excerpts from warning letter sent to sub-investigator

•     Several letters were sent out as a result of this clinical
      trial to several participating institutions and staff.




                                                                                      37



    FDA Warning Letter Form FDA 483: Nov 30, 2000, S. Raper, M.D., Philadelphia, PA
Case Studies
Corrective Actions



      “Please advise this office, in writing, within (15)
      working days of receipt of this letter, of the
      specific steps you have taken or plan to take to
      correct these violations and prevent the
      recurrence of similar violations. Failure to
      respond can result in the initiation of regulatory
      action without further notice, including, as
      described in 21 CFR 56.120, withholding
      approval of new studies, and notifying relevant
      State and Federal regulatory agencies.”

                                                            38
Training


Positive ROI (Time & Budget)
   • Compliance with ICH/GCP Guidelines
   • Subject protection
   • Integrity and quality of clinical trial
   • Increase revenues for successful regulatory approval
   • Additional products
   • Effective treatment available for medical field
   • Timely product market approval by Regulatory Agency

                                                            39
Negative ROI


  • No benefit or possible harm caused to subject
  • Loss of revenue on daily basis can be $1 million or
    more per day
  • Re-analyze integrated safety summaries
     – Cost of disqualified study
     – Loss of data
  • Discredited/tarnished reputation (priceless)
     – Corporate
     – Institution
     – Personal
                                                          40
Summary


Raising the bar on training must take into consideration
  accountability
   • Changes in the entire industry
   • Cost and time should not be a factor
   • Effective and acceptable training methods
       – Increase frequency and continuous certification process
   • Expand training and awareness across all organizations
       –   Medical                        IRB
       –   Marketing                      Investigator
       –   Regulatory                     Site staff
       –   Sales                          Administrators
                                                                   41
       – Corporate and executive management and officers
 Closing


Comprehensive and successful methods of ICH training can
  result in a positive return on the investment of time and
  budget

      • The investment in Rx development is exorbitant
      • The current need and future effective treatments
        for disease and illness is in drug development
      • The need for trained and skilled researchers is
        increasing
      • The pharmaceutical research and manufactures
        industry and clinical research is under extreme       42
        scrutiny
Raise The Bar & Invest Now!




 Help all become knowledgeable of the importance of GCP
  training in protecting the rights, well being and safety of
  the human subject




                                                Thank you

                                                                43
Taking GCP Training To A New Level




Ruth Ann Nylen, PhD
The RAN Institute, Inc
Tampa, Florida, USA




                                     44
The True Measure of GCP Training Effectiveness




     Passing an FDA or OHRP inspection!




                                                 45
Training Clinical Research Personnel




        • What should we train on?
        • How should we train?




                                       46
GCP Training Content Requirements For Investigators




    Studies conducted under an IND:
     • Provide the scope of GCP (ethics, history,
       basis of GCP)
     • US FDA Regulations
     • ICH GCP Guideline
     • Relevant FDA Guidelines
                                                    47
GCP Training Content Requirements For Investigators/
Sponsor/CRO Personnel




       • The Scope and Basis of GCP
       • Relevant GCP History
       • Regulations and Guidelines


                                                       48
GCP Training Content




  FDA Regulations
  • 21 CFR 312 Investigational New Drugs
  • 21 CFR 314 New Drug Applications
  • 21 CFR 812 Investigational Device Exemptions
  • 21 CFR 814 Pre-market approval applications


                                                   49
GCP Training Content




 DHHS Regulation
 • 45 CFR 46 Protection of Human Subjects
 • Other requirements for federally-funded research




                                                      50
GCP Training Content



 • ICH GCP Guideline
 • Other relevant ICH guidelines
 • FDA Guideline for the Monitoring of Clinical
   Investigations
 • FDA Information Sheets for IRBs and Clinical
   Investigators
 • Form FDA 1572 requirements

                                                  51
GCP Training Content




 Studies not conducted under an IND
 • Provide the scope of GCP (ethics, history, basis of
   GCP)
 • Comprehensive review of the ICH GCP Guideline
 • Relevant country or local regulations/guidelines


                                                         52
References for Regulations and Guidelines




  •   www.ich.org
  •   www.fda.gov
  •   www.regsource.com
  •   www.nih.gov


                                            53
Moving From “What” To “How”




                              54
Challenges In Global Training



 • Location
 • Language
 • GCP & research knowledge and experience of
   participants and trainer
 • Culture
 • Infrastructure
 • Time
                                                55
Challenges: Venues



  Options for Delivery
    • Videoconference
    • Live classroom
    • CD-ROM
    • Interactive web-based training


                                       56
Challenges: Learning Transfer




 The transfer of learning from the training setting
 to actual job performance is a critical concern.




                                                      57
Time-tested Facts About Adult Learning




 • Adults learn best by doing.
 • The training method must mirror the expected
   performance of the learner.




                                                  58
Recommendations For Effective GCP Training




       Demonstration of Competency




                                             59
Recommendations For Effective GCP Training




 Examples of GCP training with a
 performance goal in mind.
   • CRF Completion by Investigators
   • Preparing a Final Drug Accountability Report



                                                    60
Bottom Line Recommendation For Effective GCP Training




       The most effective method for GCP
       training is to teach GCP from the
       perspective of the process and activities
       the learner will perform.



                                                   61
Training Methods




 1. Lecture/Presentation
    •   A one-way street
    •   Passive, not active
    •   Reaches 10% of participants
    •   Example


                                      62
Training Methods




 2. Demonstration
    •   If visual, reaches 50%
    •   Begins to emulate application
    •   Much better than lecture/presentation



                                                63
Training Methods




 2. Visual/Demonstration
    •   Subjects with a history of hepatic disease
        within the past 10 years may not be enrolled
        in this study. This includes:
        – Hepatitis
        – Elevated LFTs for a period of longer than…


                                                       64
Training Methods




 2. Demonstration
    •   If visual, reaches 50%
    •   Begins to emulate application
    •   Much better than lecture/presentation



                                                65
Training Methods




 3. Experiential
    •   Reaches 40%
    •   Allows self-testing
    •   Begins demonstration of competency



                                             66
Training Methods


 3. Experiential
     A subject had an episode of elevated
     AST/ALT following a toxic exposure to
     environmental organic solvents in his
     workplace, during October, 1992.            The
     subject recovered with no sequelae.
     According to the protocol inclusion criteria, is
     this subject eligible to enter this study, based
     on the criteria described?
                                                        67
Training In Context




 1.   Provide practice opportunity for critical tasks.
 2.   Check for accuracy/understanding.
 3.   Give feedback.
 4.   Repeat until the learner performs correctly.



                                                         68
Training Outside Of Context




 Problems
 •   Nothing is relevant.
 •   Little is remembered.
 •   Even less is applied.




                              69
Recommendations For Effective GCP Training




1. Train in context to maximize learning transfer.
2. Test the participants to ensure competency has
   been acquired.




                                                     70
Incorporating Creativity Into
    Global GCP Training




                                71
Thinking Outside The Box Can Make A Difference




                                                 72
Thinking Outside The Box Can Make A Difference




 1. Connect all the dots
 2. Using one single pen
    flow to connect with
    only four lines




                                                 73
Thinking Outside The Box Can Make A Difference




     Solution!




                                                 74
Inside The Box



• Thinking inside the box means
  accepting the status quo.
• For example, Charles H. Duell,
  Director of the US Patent Office,
  said, "Everything that can be
  invented has been invented."
• That was in 1899: clearly he was
  in the box!

                                      75
Training Techniques To Connect With The Participants




   • Reach out to engage – interact – ask questions
   • Find needs before you fill needs
   • Answer questions directly




                                                       76
A View From The Participant’s Seat



 • Why are you training/educating me?
 • Can you communicate effectively to me?

 • What do you intend to accomplish and
       have me take home?

 • Will you follow-up?



                                            77
Knowing Your Audience




  •   Who are they?
  •   Where do they come from?
  •   What is their experience?
  •   What are their needs/concerns?




                                       78
Knowing Your Audience




                        79
Knowing Your Audience - Resources



• http://www.executiveplanet.com/index2.jsp
   Tips for U.S. business travelers on foreign culture and etiquette
   for selected countries




• http://www.hbcollege.com/management/students/bus_etiquette.htm
   Test your business etiquette

                                                                       80
The Bottom Line




• Tailor the method of delivery to the expected performance.
• People that have an accent or don’t speak English are not
       stupid nor are they hard of hearing.
• Be sensitive and understanding, remember what you are
       there to do.
• Develop a training plan specific to each audience.


                                                               81
GCP Training: Techniques And Tools



 • Assessment Testing: Pre/Post
 • Promote a consistent message among investigators
   and sponsor personnel.
 • Provide a global question and answer forum.
 • Know your SOPs, GCPs, ICH guidelines
 • Encourage open discussions
 • Keep focused


                                                      82
Software To Spice Up Training/Educating



Gameshow Pro3
Is That Your Final Answer Jeopardy /
Family Feud / Tic Tac Toe game shows /
Create Millionaire type games shows



Gameshow Presenter - software
Create a game show with minimal expense


                                          83
Software To Spice Up Training/Educating


     Classroom Bingo
     B-I-N-G-O makes classroom learning
     fun




     •http://www.trainerswarehouse.com
     •http://www.trainingsupersite.com
                                          84
Summary



• Generate creative solutions to your challenges through
  thinking outside the box ideas
• Be Enthusiastic, Understanding, Knowledgeable, &
  Compliant
• Know your audience
• Reach out to engage (get info)
• Relate to their needs (give info)
• Respond to their needs
• Tailor the method of delivery to the expected performance
                                                              85
Summary




 “You tell me, and I forget.
 You teach me, and I
 remember. You involve
 me, and I learn.”

          -Benjamin Franklin

                               86
Slides available at
www.raninstitute.com




                       87

				
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Description: Compliance with ICH/GCP provides public assurance that the rights, safety, and well being of trial subjects are protected consistent with the principles…of the Declaration of Helsinki …