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20070327 1/50 CERTIFICATION OF INVESTIGATORS CERTIFICATION OF (CLINICAL) INVESTIGATORS Prof. Jan. Hasker G. Jonkman, 20070327 1/50 CERTIFICATION OF INVESTIGATORS CERTIFICATION OF (CLINICAL) INVESTIGATORS Prof. Jan. Hasker 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 JHGJ/gh

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

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

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

20070327 5/50 CERTIFICATION OF INVESTIGATORS GENERAL (2) A high quality clinical study has to 20070327 5/50 CERTIFICATION OF INVESTIGATORS 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 JHGJ/gh

20070327 6/50 CERTIFICATION OF INVESTIGATORS GENERAL (3) High quality clinical study data require Investigators 20070327 6/50 CERTIFICATION OF INVESTIGATORS GENERAL (3) 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 JHGJ/gh

20070327 7/50 CERTIFICATION OF INVESTIGATORS GENERAL (4) Are required knowledge and skills present? (1) 20070327 7/50 CERTIFICATION OF INVESTIGATORS GENERAL (4) Are required knowledge and skills present? (1) • Investigators sign Form 1572 (FDA) declaring that 4 they are qualified to conduct and 4 are fully responsible for all aspects of the clinical study JHGJ/gh

20070327 8/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 8/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 9/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 9/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 10/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 10/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 11/50 CERTIFICATION OF INVESTIGATORS GENERAL (5) Are required knowledge and skills present? (2) 20070327 11/50 CERTIFICATION OF INVESTIGATORS GENERAL (5) 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’) JHGJ/gh

20070327 12/50 CERTIFICATION OF INVESTIGATORS GENERAL (6) ‘These are the issues clinical trial sites 20070327 12/50 CERTIFICATION OF INVESTIGATORS 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 JHGJ/gh

20070327 13/50 CERTIFICATION OF INVESTIGATORS GENERAL (7) ‘The single most important step we could 20070327 13/50 CERTIFICATION OF INVESTIGATORS 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 JHGJ/gh

20070327 14/50 CERTIFICATION OF INVESTIGATORS GENERAL (8) ‘Heute ist die Durchführung Klinischer Prüfungen ohne 20070327 14/50 CERTIFICATION OF INVESTIGATORS GENERAL (8) ‘Heute ist die Durchführung Klinischer Prüfungen ohne Spezialkenntnisse gar nicht denkbar’ Dr. Med. Norbert Clemens, Bundesvorsitzender Deutschen Gesellschaft für Pharmazeutische Medizin e. V. (DG Phar. Med, 2007) JHGJ/gh

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

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

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

20070327 18/50 CERTIFICATION OF INVESTIGATORS GENERAL (9) Training - The Netherlands • University Groningen 20070327 18/50 CERTIFICATION OF INVESTIGATORS GENERAL (9) Training - The Netherlands • University Groningen (+ University Utrecht) GUIDE - Course ‘Good Research Practices GCP/GLP’ (since 1993) 4 Post graduate course 4 also open to external professionals • Several commercial (in-house) courses JHGJ/gh

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

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

20070327 21/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 21/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 22/50 CERTIFICATION OF INVESTIGATORS GENERAL (11) Reasons for Certification (1) • May improve 20070327 22/50 CERTIFICATION OF INVESTIGATORS GENERAL (11) 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. JHGJ/gh

20070327 23/50 CERTIFICATION OF INVESTIGATORS GENERAL (12) Reasons for Certification (2) • (Together with 20070327 23/50 CERTIFICATION OF INVESTIGATORS GENERAL (12) 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’) JHGJ/gh

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

20070327 25/50 CERTIFICATION OF INVESTIGATORS HISTORY (1) • USA 4 ACRP* (Association of Clinical 20070327 25/50 CERTIFICATION OF INVESTIGATORS HISTORY (1) • USA 4 ACRP* (Association of Clinical Research Professionals) q 1992: certification of Clinical Research Co-ordinations (CRCs) q 1995: certification of Clinical Research Associates (CRAs) q 2002: certification of Physician Investigators (PI) 4 approximately 14. 000 people certified * www. ACRPnet. org JHGJ/gh

20070327 26/50 CERTIFICATION OF INVESTIGATORS HISTORY (2) • USA 4 DIA* (Drug Information Association) 20070327 26/50 CERTIFICATION OF INVESTIGATORS HISTORY (2) • USA 4 DIA* (Drug Information Association) q 2002: certification of Clinical Investigators 4 SOCRA** (Society of Clinical Research Associates) q 1995: certification of Clinical Research Professionals 4 AAPP (American Academy of Pharmaceutical Physicians) 4 APPI (Academy of Pharmaceutical Physicians and Investigators; until 2003: AAPP = American Academy of Pharmaceutical Physicians) q 2003: certification of Physician Investigators * www. diahome. org ** www. SOCRA. org JHGJ/gh

20070327 27/50 CERTIFICATION OF INVESTIGATORS HISTORY (3) • USA • 2006: 4 Certification programs 20070327 27/50 CERTIFICATION OF INVESTIGATORS HISTORY (3) • USA • 2006: 4 Certification programs of DIA and APPI have been consolidated with ACRP programme resulting in two new affiliates of ACRP: q. Academy of Clinical Research Professionals (The Academy) for certification of non-physicians (CCRA = Certified Clinical Research Associate; CCRC = Certified Clinical Research Coordinator) q. APPI for certification of physicians (CPI = Certified Physician Investigator) JHGJ/gh

20070327 28/50 CERTIFICATION OF INVESTIGATORS HISTORY (4) • USA 4 total number of certificates: 20070327 28/50 CERTIFICATION OF INVESTIGATORS HISTORY (4) • USA 4 total number of certificates: approximately 17. 500 of which physicians approximately 400 JHGJ/gh

20070327 29/50 CERTIFICATION OF INVESTIGATORS HISTORY (5) • Europe 4 ACRP 4 ECCRT (European 20070327 29/50 CERTIFICATION OF INVESTIGATORS HISTORY (5) • Europe 4 ACRP 4 ECCRT (European Centre for Clinical Research Training) JHGJ/gh

20070327 30/50 CERTIFICATION OF INVESTIGATORS HISTORY (6) • Germany 4 DG Phar. Med • 20070327 30/50 CERTIFICATION OF INVESTIGATORS HISTORY (6) • Germany 4 DG Phar. Med • The Netherlands 4 GUIDE* Graduate School for Drug Exploration Certificate ‘Good Research Practices GCP / GLP’ University of Groningen • Belgium 4 PHARMED** Post-graduate programme in pharmacology and pharmaceutical medicine (University Brussels) * www. rug. nl/guide or www. pharmadvices. com **ulb. ac. be/medicine/pharmedwww JHGJ/gh

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

20070327 32/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (1) New initiative for e-learning 20070327 32/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (1) New initiative for e-learning / e-testing / certification GCP (1) • 2004: 4 Prof. Dr. Jan. Hasker G. Jonkman, University of Groningen 4 Drs. Bert Harenberg, Media. Vision, Laren JHGJ/gh

20070327 33/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (2) New initiative for e-learning 20070327 33/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (2) New initiative for e-learning / e-testing / certification GCP (2) • 2005: 4 other founding members (‘Initiating Group’) q. Dr. Helena van den Dungen (Dutch GCP Inspectorate) q. Dr. Herman Pieterse (GCP Consultant) q. Cecilia Huisman (ACRP; NVRV) q. Dr. Philip Salden (Nefarma) q. Dr. Rudolf van Olden (NVFG) q. Drs. Pieter Guelen (ACRON) 4 completion of a printed ‘proposal’ entitled ‘GCP - The necessity of GCP-examination in The Netherlands’ JHGJ/gh

20070327 34/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 34/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 35/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (3) • 2006 (1): 4 20070327 35/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (3) • 2006 (1): 4 verbal commitment CCMO (Dr. M. Kenter) 4 contacts with NFU (Nederlandse Federatie Universiteiten; UMCs) qintention for a cooperation to design an exam in line with requirements of NFU (subject: ‘Wet en Regelgeving’) JHGJ/gh

20070327 36/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (4) • 2006 (2): 4 20070327 36/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (4) • 2006 (2): 4 On November 09; Stichting Certificering Klinisch Wetenschappelijk Onderzoeker (Foundation for Certification of Clinical Researchers) qresidence: 4 Assen qboard: 4 Prof. Dr. J. H. G. Jonkman 4 Prof. Dr. R. A. de Zeeuw 4 Dr. R. W. van Olden JHGJ/gh

20070327 37/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (5) Stichting CKWO: Objectives 1. 20070327 37/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (5) 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 JHGJ/gh

20070327 38/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (6) • 2006 (3): 4 20070327 38/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (6) • 2006 (3): 4 Start of Editiorial Board qprepare first three exams qextended with two members on behalf of the NFU 4 Dr. Mieke Trip (AMC) 4 Dr. A. J. M. Craen (UMCL) 4 Dr. Rudolf van Olden was replaced by Drs. Alexandra Smeur-van Andel JHGJ/gh

20070327 39/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (7) Concept of exam: • 20070327 39/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (7) 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’) JHGJ/gh

20070327 40/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (8) The system of examination 20070327 40/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (8) 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 4 choose modules in own order 4 choose time and place of examination JHGJ/gh

20070327 41/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (9) The system of examination 20070327 41/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (9) 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’ JHGJ/gh

20070327 42/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (10) The system of examination 20070327 42/50 CERTIFICATION OF INVESTIGATORS PRESENT SITUATION: THE NETHERLANDS (10) The system of examination will fulfil the following requirements (3): • 2007 4 June: first ‘try-out’ of examination in University Medical Center Amsterdam (AMC) (with three different video’s / test cases) JHGJ/gh

20070327 43/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 43/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

20070327 44/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh 20070327 44/50 CERTIFICATION OF INVESTIGATORS JHGJ/gh

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

20070327 46/50 CERTIFICATION OF INVESTIGATORS FUTURE (1) • Prepare a publicly available list of 20070327 46/50 CERTIFICATION OF INVESTIGATORS 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’) JHGJ/gh

20070327 47/50 CERTIFICATION OF INVESTIGATORS FUTURE (2) • More extensive use of the facilities 20070327 47/50 CERTIFICATION OF INVESTIGATORS 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’ JHGJ/gh

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

20070327 49/50 CERTIFICATION OF INVESTIGATORS CONCLUSIONS (1) • Solid training in clinical research is 20070327 49/50 CERTIFICATION OF INVESTIGATORS 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 should be easily recognized by other stakeholders (Sponsors, authorities, Medical Ethics Committees, potential study participants, editors of journals, etc. ) JHGJ/gh

20070327 50/50 CERTIFICATION OF INVESTIGATORS CONCLUSIONS (2) • All opportunities of ‘e-learning’ and ‘e-testing’ 20070327 50/50 CERTIFICATION OF INVESTIGATORS 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 JHGJ/gh