20070327 1/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.,

20070327 1/50 CERTIFICATION OF INVESTIGATORS

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CERTIFICATION OF

(CLINICAL) INVESTIGATORS

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) INVESTIGATORS

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


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Definition:

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

GENERAL (1)


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A high quality clinical study has to be performedin accordance with:

• Appropriate ethical standards

• Appropriate medical standards

• Appropriate scientific standards

• Appropriate legal standards

• Appropriate regulatory standards

GENERAL (2)


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High quality clinical study data require Investigators 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

GENERAL (3)


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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

GENERAL (4)


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Are required knowledge and skills present? (2)

• There is examination of medical knowledge and professional skills

but

• There is no examination of knowledge and skills on clinical research (‘Good Research Practices’)

GENERAL (5)


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‘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

GENERAL (6)


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‘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

GENERAL (7)


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‘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)

GENERAL (8)


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Source: The CenterWatch Monthly, November 2006


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Training - The Netherlands

• University Groningen (+ University Utrecht)

GUIDE - Course ‘Good Research Practices GCP/GLP’ (since 1993)

Post graduate course

also open to external professionals

• Several commercial (in-house) courses

GENERAL (9)


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Source: Good Clinical Practice Journal, September 2004, p19-22


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Definition:

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

GENERAL (10)


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Reasons for Certification (1)

• May improve safety of subjects

• May improve quality data

• Conveys a commitment to clinical research

• Provides assurance to Sponsor, authorities, Medical Ethics Committees, study participants and editors of journals that investigator understands requirements of GCP etc.

GENERAL (11)


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Reasons for Certification (2)

• (Together with training): intellectual stimulation / professional development

• Business advantage (for ‘commercial’ Investigators)

(N.B. In The Netherlands the law requires that an investigator has a

certificate in order to be allowed to perform animal experiments; ‘Art. 9’)

GENERAL (12)


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• 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 14.000 people certified

HISTORY (1)

* www.ACRPnet.org


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• 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

HISTORY (2)

* www.diahome.org ** www.SOCRA.org


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• 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)

HISTORY (3)


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• USA total number of certificates: approximately 17.500

of which physicians approximately 400

HISTORY (4)


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• Europe ACRP

ECCRT (European Centre for Clinical Research Training)

HISTORY (5)


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• Germany DG PharMed

• The Netherlands GUIDE* Graduate School for Drug Exploration

Certificate ‘Good Research Practices GCP / GLP’ University of Groningen

• Belgium PHARMED** Post-graduate programme in pharmacology

and pharmaceutical medicine (University Brussels)

HISTORY (6)

* www.rug.nl/guide or www.pharmadvices.com **ulb.ac.be/medicine/pharmedwww


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New initiative for e-learning / e-testing / certification GCP (1)

• 2004: Prof.Dr. JanHasker G. Jonkman, University of Groningen

Drs. Bert Harenberg, MediaVision, Laren

PRESENT SITUATION: THE NETHERLANDS (1)


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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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• 2006 (1): verbal commitment CCMO (Dr. M. Kenter)

contacts with NFU (Nederlandse Federatie Universiteiten; UMCs)

intention for a cooperation to design an exam in line with requirements of NFU (subject: ‘Wet en Regelgeving’)



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• 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



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Stichting CKWO: Objectives

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

2. a. To establish and maintain a system for certification of clinical researchers

b. To establish a system for examination in order to reach this objective of certification

3. The Foundation is a non-profit organization



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• 2006 (3): Start of Editiorial Board

prepare first three exams

extended with two members on behalf of the NFU Dr. Mieke Trip (AMC)

Dr. A.J.M. Craen (UMCL)

Dr. Rudolf van Olden was replaced by Drs. Alexandra Smeur-van Andel



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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’)When the answer is wrong, the right answer will be given by the computer (= ‘Learning’)



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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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• 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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• 2007 June:

first ‘try-out’ of examination in University Medical Center Amsterdam (AMC) (with three different video’s / test cases)



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• 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’)

FUTURE (1)


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• 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’

FUTURE (2)


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• 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 should be easily recognized by other stakeholders (Sponsors, authorities, Medical Ethics Committees, potential study participants, editors of journals, etc.)

CONCLUSIONS (1)


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• 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

CONCLUSIONS (2)

Documents

20070327 1/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph.,