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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.,

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Presentation on theme: "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.,"— Presentation transcript:

1 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., Clinical Pharmacologist University of Groningen (NL) Professor Quality Management in Drug Research and Manufacturing Stichting Certificering Klinisch Wetenschappelijk Onderzoeker

2 20070327 2/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

3 20070327 3/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

4 20070327 4/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Definition: Certification is the official proof - in writing and confirmed by signature - of the presence of knowledge and the ability to perform GENERAL (1)

5 20070327 5/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 GENERAL (2)

6 20070327 6/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

7 20070327 7/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

8 20070327 8/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

9 20070327 9/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

10 20070327 10/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

11 20070327 11/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

12 20070327 12/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

13 20070327 13/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

14 20070327 14/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

15 20070327 15/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Source: The CenterWatch Monthly, November 2006

16 20070327 16/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Source: The CenterWatch Monthly, November 2006

17 20070327 17/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Source: The CenterWatch Monthly, November 2006

18 20070327 18/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

19 20070327 19/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Source: Good Clinical Practice Journal, September 2004, p19-22

20 20070327 20/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Definition: Certification is the official proof - in writing and confirmed by signature - of the presence of knowledge and the ability to perform GENERAL (10)

21 20070327 21/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

22 20070327 22/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

23 20070327 23/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

24 20070327 24/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

25 20070327 25/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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

26 20070327 26/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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

27 20070327 27/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

28 20070327 28/50CERTIFICATION OF INVESTIGATORS JHGJ/gh USA total number of certificates: approximately 17.500 of which physicians approximately 400 HISTORY (4)

29 20070327 29/50CERTIFICATION OF INVESTIGATORS JHGJ/gh Europe ACRP ECCRT (European Centre for Clinical Research Training) HISTORY (5)

30 20070327 30/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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

31 20070327 31/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

32 20070327 32/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

33 20070327 33/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (2)

34 20070327 34/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

35 20070327 35/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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) PRESENT SITUATION: THE NETHERLANDS (3)

36 20070327 36/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (4)

37 20070327 37/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (5)

38 20070327 38/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (6)

39 20070327 39/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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) PRESENT SITUATION: THE NETHERLANDS (7)

40 20070327 40/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (8)

41 20070327 41/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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 PRESENT SITUATION: THE NETHERLANDS (9)

42 20070327 42/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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) PRESENT SITUATION: THE NETHERLANDS (10)

43 20070327 43/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

44 20070327 44/50CERTIFICATION OF INVESTIGATORS JHGJ/gh

45 20070327 45/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

46 20070327 46/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

47 20070327 47/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

48 20070327 48/50CERTIFICATION OF INVESTIGATORS JHGJ/gh CERTIFICATION OF (CLINICAL) INVESTIGATORS TABLE OF CONTENTS General History Present Situation Future Conclusions

49 20070327 49/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)

50 20070327 50/50CERTIFICATION OF INVESTIGATORS JHGJ/gh 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)


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