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CERTIFICATION OF (CLINICAL) RESEARCH STAFF Prof. JanHasker G. Jonkman,

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 Prof. JanHasker G. Jonkman,

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  1. 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

  2. CERTIFICATION OF (CLINICAL) RESEARCH STAFF TABLE OF CONTENTS • General • History • Present Situation • Future • Conclusions

  3. CERTIFICATION OF (CLINICAL) RESEARCH STAFF TABLE OF CONTENTS • General • History • Present Situation • Future • Conclusions

  4. GENERAL (1) Definition: • Certification is the official proof - in writing and confirmed by signature - of the presence of knowledge and the ability to perform

  5. 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

  6. 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

  7. 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)

  8. 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

  9. GENERAL (6) ‘These are the issues clinical trial sitesare 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

  10. 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

  11. 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)

  12. Source: The CenterWatch Monthly, November 2006

  13. Source: The CenterWatch Monthly, November 2006

  14. Source: The CenterWatch Monthly, November 2006

  15. 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

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

  17. GENERAL (10) Training - The Netherlands (2) • Hogeschool Rotterdam (‘Transfergroep Rotterdam & Omstreken: TR&O’; 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

  18. GENERAL (11) Definition: • Certification is the official proof - in writing and confirmed by signature - of the presence of knowledge and the ability to perform

  19. 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.

  20. 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 animalexperiments; ‘Art. 9’)

  21. CERTIFICATION OF (CLINICAL) RESEARCH STAFF TABLE OF CONTENTS • General • History • Present Situation • Future • Conclusions

  22. 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

  23. 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

  24. 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

  25. HISTORY (4) • Europe Certification by: • ECCRT (European Centre for Clinical Research Training) • ACRP

  26. 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

  27. HISTORY (6) • Germany • DG PharMed-certificate • Belgium • PHARMED* Post-graduate programme in pharmacology and pharmaceutical medicine (University Brussels) *ulb.ac.be/medicine/pharmedwww

  28. 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

  29. CERTIFICATION OF (CLINICAL) RESEARCH STAFF TABLE OF CONTENTS • General • History • Present Situation • Future • Conclusions

  30. 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

  31. 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’

  32. PRESENT SITUATION: THE NETHERLANDS (3) • 2006 (1): • verbal commitment CCMO (Dr. M. Kenter) • contacts with NFU (Nederlandse Federatie Universitaire Medische Centra’s; 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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’)

  38. 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

  39. 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’

  40. 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 video’s / test cases)

  41. CERTIFICATION OF (CLINICAL) RESEARCH STAFF TABLE OF CONTENTS • General • History • Present Situation • Future • Conclusions

  42. 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’)

  43. 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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