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CERTIFICATION OF (CLINICAL) RESEARCH
STAFF Prof. JanHasker G. Jonkman, Ph.D.,
F.C.P., F.R.Q.A., R.Ph., Clinical
Pharmacologist University of Groningen
(NL) Professor Quality Management in Drug
Research and Manufacturing Stichting
Certificering Klinisch Wetenschappelijk
Onderzoeker
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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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GENERAL (1)

• Definition
• Certification is the official proof - in writing
  and confirmed by signature - of the presence of
  knowledge and the ability to perform

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GENERAL (2)

• A high quality clinical study has to be performed
• in accordance with
• Appropriate ethical standards
• Appropriate medical standards
• Appropriate scientific standards
• Appropriate legal standards
• Appropriate regulatory standards

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GENERAL (3)

• High quality clinical study data require research
  staff with
• Superior medical professional knowledge and
  skills for the safe conduct of a clinical study
• Solid knowledge of Good Research Practices for
  an ethical conduct of a clinical study

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GENERAL (4)

• Are required knowledge and skills present? (1)
• Investigators sign Form 1572 (FDA) declaring that
• they are qualified to conduct
• and
• are fully responsible for all aspects of the
  clinical study(may delegate certain tasks, but
  stay responsible)

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GENERAL (5)

• Are required knowledge and skills present? (2)
• There is examination of medical knowledge and
  professional skills at the end of (university)
  study
• but
• Good Research Practices is not a part of the
  standard curriculum of the medical training
• There is no official accredited examination of
  knowledge and skills on clinical research (Good
  Research Practices) at end of study in The
  Netherlands

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GENERAL (6)

• These are the issues clinical trial sites are
• struggling with based on my inspections.
• But number one on the list is lack of GCP
• knowledge and training
• Mike M. Rashti,
• Food and Drug Administration, FDA, USA, 2006

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GENERAL (7)

• The single most important step we could take
• to improve clinical trials.. is to make sure
  that
• those doing the research are qualified to do it
• Greg Koski,
• Former Director of Office of Human
• Research Protections, OHRP, USA, 2004

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GENERAL (8)

• Heute ist die Durchführung Klinischer Prüfungen
• ohne Spezialkenntnisse gar nicht denkbar
• Dr. Med. Norbert Clemens,
• Bundesvorsitzender der Deutschen Gesellschaft
• für Pharmazeutische Medizin e.V.
• (DG PharMed, 2007)

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Source The CenterWatch Monthly, November 2006
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Source The CenterWatch Monthly, November 2006
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Source The CenterWatch Monthly, November 2006
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GENERAL (9)

• Training - The Netherlands (1)
• University Groningen ( University Utrecht)
• GUIDE - Course Good Research Practices GCP/GLP
  (since 1993)
• Post graduate course
• two weeks, full-time
• also open to external professionals
• certificate

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Source Good Clinical Practice Journal, September
2004, p19-22
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GENERAL (10)

• Training - The Netherlands (2)
• Hogeschool Rotterdam (Transfergroep Rotterdam
  Omstreken TRO since 1997)
• Post-HBO training
• research nurse
• Clinical Research Associate (CRA)
• 18 months (not full-time) (including 22 contact
  days total 730 study hours)
• Post-HBO accredited
• Several commercial (in-house) courses

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GENERAL (11)

• Definition
• Certification is the official proof - in writing
  and confirmed by signature - of the presence of
  knowledge and the ability to perform

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GENERAL (12)

• Reasons for Certification (1)
• May improve safety of subjects
• May improve quality data
• Conveys a commitment to clinical research
  (GCP-minded)
• Provides assurance to Sponsor, authorities,
  Medical Ethics Committees, study participants
  and editors of journals that investigator
  understands requirements of GCP etc.

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GENERAL (13)

• Reasons for Certification (2)
• (Together with training) intellectual
  stimulation / professional development
• Business advantage (for commercial
  Investigators)
• (N.B. In The Netherlands the law requires since
  1977 that
• an investigator has a certificate in order to be
  allowed to perform
• animal experiments Art. 9)

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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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HISTORY (1)

• USA
• ACRP (Association of Clinical Research
  Professionals)
• 1992 certification of Clinical Research
  Co-ordinations (CRCs)
• 1995 certification of Clinical Research
  Associates (CRAs)
• 2002 certification of Physician Investigators
  (PI)
• approximately 16.000 people certified

www.ACRPnet.org
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HISTORY (2)

• USA
• DIA (Drug Information Association)
• 2002 certification of Clinical Investigators
• SOCRA (Society of Clinical Research Associates)
  
• 1995 certification of Clinical Research
  Professionals
• AAPP (American Academy of Pharmaceutical
  Physicians)
• APPI (Academy of Pharmaceutical Physicians and
  Investigators until 2003 AAPP American
  Academy of Pharmaceutical Physicians)
• 2003 certification of Physician Investigators

www.diahome.org www.SOCRA.org
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HISTORY (3)

• USA (2006)
• Certification programs of DIA and APPI have been
  consolidated with ACRP programme resulting in
  two new affiliates of ACRP
• Academy of Clinical Research Professionals(The
  Academy) for certification of non-physicians(CCRA
  Certified Clinical Research Associate CCRC
  Certified Clinical Research Coordinator)
• APPI for certification of physicians(CPI
  Certified Physician Investigator)
• total number of certificates approximately
  16.000 of which physicians approximately 600

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HISTORY (4)

• Europe
• Certification by
• ECCRT (European Centre for Clinical Research
  Training)
• ACRP

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HISTORY (5)

• Europe
• In 2006
• ACRP certified 868 clinical research
  professionals during their Fall 2006 exam
• of which 27 in the EU-region (mainly Eastern
  Europe)
• of which 2 in The Netherlands
• APPI certified 43 physician investigators
• of which 2 in the EU-region
• of which 0 in The Netherlands

Source The Monitor, February 2007
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HISTORY (6)

• Germany
• DG PharMed-certificate
• Belgium
• PHARMED Post-graduate programme in pharmacology
  and pharmaceutical medicine (University
  Brussels)

ulb.ac.be/medicine/pharmedwww
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HISTORY (7)

• The Netherlands
• GUIDE Graduate School for Drug Exploration
  Certificate Good Research Practices GCP / GLP
  University of Groningen
• certificate
• Hogeschool Rotterdam
• Certificate by NVRV (Nederlandse Vereniging van
  Research Verpleegkundigen Dutch Association of
  Research Nurses)

www.rug.nl/guide or www.pharmadvices.com
www.transfergroep.nl
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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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PRESENT SITUATION THE NETHERLANDS (1)

• New initiative for e-learning / e-testing /
  certification GCP (1)
• 2004
• Prof.Dr. JanHasker G. Jonkman, University of
  Groningen
• Drs. Bert Harenberg, MediaVision, Laren

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PRESENT SITUATION THE NETHERLANDS (2)

• New initiative for e-learning / e-testing /
  certification GCP (2)
• 2005
• other founding members (Initiating Group)
• Dr. Helena van den Dungen (Dutch GCP
  Inspectorate)
• Dr. Herman Pieterse (GCP Consultant)
• Cecilia Huisman (ACRP NVRV)
• Dr. Philip Salden (Nefarma)
• Dr. Rudolf van Olden (NVFG)
• Drs. Pieter Guelen (ACRON)
• completion of a printed proposal entitled GCP
  - The necessity of GCP-examination in The
  Netherlands

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PRESENT SITUATION THE NETHERLANDS (3)

• 2006 (1)
• verbal commitment CCMO (Dr. M. Kenter)
• contacts with NFU (Nederlandse Federatie
  Universitaire Medische Centras UMCs)
• intention for a cooperation to design an exam in
  line with requirements of NFU (subject Wet en
  Regelgeving)
• contacts with STZ (Vereniging Samenwerkende
  Topklinische Ziekenhuizen)
• intention for a cooperation

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PRESENT SITUATION THE NETHERLANDS (4)

• 2006 (2)
• On November 09 Stichting Certificering
  Klinisch Wetenschappelijk Onderzoeker
  (Foundation for Certification of Clinical
  Researchers)
• residence
• Assen
• board
• Prof.Dr. J.H.G. Jonkman
• Prof.Dr. R.A. de Zeeuw
• Dr. R.W. van Olden
• Mr. R.W. Botzen

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PRESENT SITUATION THE NETHERLANDS (5)

• Stichting CKWO Objectives (1)
• 1. a. To improve the quality of clinical
  research in The Netherlands as well as
  elsewhere
• b. To perform all actions that will be
  necessary to reach the above mentioned
  objective

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PRESENT SITUATION THE NETHERLANDS (6)

• Stichting CKWO Objectives (2)
• 2. a. To establish and maintain a system for
  certification of clinical researchers
  (which is accredited by the authorities)
• b. To establish a system for examination in
  order to reach this objective of
  certification (also based on the national
  regulatory situation WMO!)
• 3. The Foundation is a non-profit organization

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PRESENT SITUATION THE NETHERLANDS (7)

• 2006 (3)
• Start of Editiorial Board
• prepare first three exams
• extended with two members on behalf of the NFU
• Dr. M. Trip (AMC)
• Dr. A.J.M. de Craen (UMCL)
• Dr. R. van Olden was replaced by Drs. A.
  Smeur-van Andel

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PRESENT SITUATION THE NETHERLANDS (8)

• Concept of exam
• Learning by Testing
• Each exam consists of different test cases
• A 3-minutes video of a real life situation
  (during a clinical study) followed by 3-5
  multiple choice questions ( Testing) and
  open questionsWhen the answer is wrong, the
  right answer will be given by the computer (
  Learning)

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PRESENT SITUATION THE NETHERLANDS (9)

• The system of examination will fulfil the
  following
• requirements (1)
• Individual training (Learning by Testing)
• Modular system with different test cases and
  different small certificates (deelcertificaten),
  together forming the full certificate
• Flexible system large freedom for candidate to
• choose modules in own order
• choose time and place of examination

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PRESENT SITUATION THE NETHERLANDS (10)

• The system of examination will fulfil the
  following
• requirements (2)
• Test cases should be interesting and stimulating
  (motivating)
• It should be able to test not only knowledge of
  rules and laws, but in particular to test
  GCP-mentality

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PRESENT SITUATION THE NETHERLANDS (11)

• The system of examination will fulfil the
  following
• requirements (3)
• 2007
• June first try-out of examination in
  University Medical Center Amsterdam (AMC)
  (with three different videos / test cases)

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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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FUTURE (1)

• Prepare a publicly available list of Certified
  Clinical Researchers (open to the public
  including all stakeholders like Sponsors,
  authorities, Medical Ethics Committees, potential
  study participants, editors of journals, etc.)
• Obtain acknowledgement of the certificate by the
  authorities e.g. comparable with title Clinical
  Pharmacologist that is recognized in the WMO
  (Wet Medisch-Wetenschappelijk Onderzoek met
  Mensen Law on Medical Research in Human
  Subjects)

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FUTURE (2)

• More extensive use of the facilities of the web
  for the examination
• May be extension to other area of Clinical
  Research rather than only Good Clinical
  Practices
• May be extension to web-based training in Good
  Research Practices (e-learning)
• Hopefully the certification contributes to
  further appreciation of The Netherlands as
  clinical trial country

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CERTIFICATION OF (CLINICAL) RESEARCH STAFF

• TABLE OF CONTENTS
• General
• History
• Present Situation
• Future
• Conclusions

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CONCLUSIONS (1)

• Solid training in clinical research is of
  paramount importance
• There are many deficiencies in the knowledge of
  several clinical researchers as far as Good
  Research Practices concerns
• The knowledge of the staff involved in clinical
  research should be easily recognized by other
  stakeholders (Sponsors, authorities, Medical
  Ethics Committees, potential study
  participants, editors of journals, etc.)

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CONCLUSIONS (2)

• All opportunities of e-learning and e-testing
  will be used for learning and examination
• Higher quality of clinical research staff will
  increase the attractiveness of The Netherlands
  as clinical trial country