Liste des fournisseurs de cours d'éthique de la recherche et GCP reconnus en Suisse
swissethics recommande vivement que les connaissances soient maintenues par des activités de recherche régulières, par exemple par la réalisation d'essais cliniques, en participant à des formations continues liées à la recherche ou à des cours de rafraîchissement des connaissances GCP, en étant exposé à des inspections GCP etc.
Un investigateur peut assumer le rôle et les responsabilités du promoteur d'un essai clinique promoteur-investigateur s'il a suivi le cours investigateur et le cours promoteur-investigateur. Le module de formation pour les promoteurs-investigateurs est uniquement valable et proposé pour les personnes ayant déjà acquis un module de formation pour les investigateurs reconnu par swissethics.
Il est recommandé aux personnes de prendre directement contact avec l’organisateur du cours pour savoir quel module de formation doit encore être accompli afin de remplir les exigences requises. Cette clarification est nécessaire parce que certains organisateurs proposent un module de formation séparé pour les promoteurs-investigateurs, tandis que d’autres réunissent le contenu des deux modules (le module pour les investigateurs et celui destiné aux promoteurs-investigateurs) en un seul cours.
Les commissions d'éthique peuvent demander aux investigateurs de suivre un nouveau cours GCP si elles estiment que les connaissances n'ont pas été maintenues.
last updated: 14. 04. 2024
| Organisation | Recognised for | Course title | Training method | Date recognised | Validity |
|---|---|---|---|---|---|
| aMRCT Center of BWH and Harward | Investigator | Interpretation and application of ICH E6(R2); this course is valid only if taken toghether with the Swiss module, e.g., from TRREE. This course has been reviewed and endorsed by the Training Subcommittee of ICH. | self-study eLearning | 14. 04. 2024 | cont. |
| AO Foundation, AO Program for Education and Excellence in Research (AOPEER) | Investigator | Study management and Good Clinical Practice | self-study eLearning | 10. 04. 2019 | cont. |
| AO Foundation, Clinical Investigation and Documentation (AOCID) | Investigator | Good Clinical Practice course (Good Clinical Practice course for surgeons) | 21. 12. 2015 | cont. | |
| Appletree CI Group AG | Investigator | The principles of clinical research in humans and GCP training for investigators | on site classroom training | 17. 12. 2015 | cont. |
| Berner Fachhochschule, BFH, Fachbereich Gesundheit | Investigator and Sponsor-Investigator | CAS Clinical Research Coordinator | classroom training / eLearning | 21. 02. 2017 | cont. |
| CRC Genève | Investigator | Bonne Pratiques des Essais Cliniques niveau I (pour les investigateurs, e-Learning): BPEC I | self-study eLearning | 12. 02. 2019 | cont. |
| CRC Genève | Investigator and Sponsor-Investigator | Bonnes Pratique des Essais Cliniques niveau II promoteur-investigateur* (the candidate must have successfully attended a GCP course for Investigators recognized by swissethics before being allowed to attend this GCP course). BPEC II | 17. 11. 2020 | cont. | |
| CRC Genève | Investigator and Sponsor-Investigator | DAS Diploma of Advanced Studies - Management of Clinical Trials, Good Clinical Practice Implementation and Quality Processes | classroom training / eLearning | 03. 12. 2015 | cont. |
| CRC Genève | Investigator and Sponsor-Investigator | MAS Master of Advanced Studies - Drug Discovery and Clinical Developement | classroom training / eLearning | 13. 04. 2016 | cont. |
| CROss research S.A. / CROss Alliance, Mendrisio | Investigator | Research Ethics and GCP | on site classroom training | 06. 02. 2017 | cont. |
| CTC Zurich | Investigator and Sponsor-Investigator | CAS Clinical Trial Management | on site classroom training | 09. 12. 2015 | cont. |
| CTC Zurich | Investigator | GCP courses Module 1, 2 | classroom training / eLearning | 09. 12. 2015 | cont. |
| CTC Zurich | Sponsor-Investigator | GCP courses Module 3 | on site classroom training | 09. 12. 2015 | cont. |
| CTU Bern | Investigator and Sponsor-Investigator | Clinical Investigator (dentists) | 10. 12. 2015 | cont. | |
| CTU Bern | Investigator | Clinical Investigator I: Basic GCP & clinical research training | classroom training / eLearning | 10. 12. 2015 | cont. |
| CTU Bern | Sponsor-Investigator | Clinical Investigator II: Advanced GCP & clinical research training | classroom training / eLearning | 10. 12. 2015 | cont. |
| CTU Bern | GCP Refresher | GCP Refresher | classroom training / eLearning | 15. 09. 2020 | cont. |
| CTU Bern / Berner Fachhochschule (BFH) | Investigator and Sponsor-Investigator | Clinical Investigators (nursing): basic and advanced GCP and clinical research training for general clinical nurses (not valid for trials of pharmaceutical products (IMP) and medical devices) | 30. 05. 2016 | cont. | |
| CTU Bern / Berner Fachhochschule (BFH) | Investigator and Sponsor-Investigator | Clinical Investigators (physiotherapy): basic and advanced GCP and clinical research training for physiotherapists (not valid for trials of pharmaceutical products (IMP) and medical devices) | 30. 05. 2016 | cont. | |
| CTU Lausanne (CHUV - FBM), course also provided by Unil/EPFL - formation continue | Investigator and Sponsor-Investigator | Formations pour investigateurs cliniques Cours Investigateurs & Cours Investigateurs-promoteur (alternative title: devenir investigateur clinique) | 26. 01. 2016 | cont. | |
| CTU St. Gallen | GCP Refresher | GCP Refresher | on site classroom training | 30. 01. 2020 | cont. |
| CTU St. Gallen | Investigator | GCP | classroom training / eLearning | 08. 12. 2015 | cont. |
| digital Trial Intervention Platform (dTIP), ETH Zurich | Investigator and Sponsor-Investigator | GCP Investigator and Sponsor-Investigator course (Module 1-3) | 15. 08. 2022 | cont. | |
| EOC CTU Bellinzona | GCP Refresher | GCP Refresher | on site classroom training | 19. 09. 2019 | cont. |
| EOC CTU Bellinzona | Investigator and Sponsor-Investigator | Research Ethics and GCP | on site classroom training | 08. 12. 2015 | cont. |
| European Center of Pharemaceutical Medicine (ECPM), University of Basel | Investigator and Sponsor-Investigator | CAS/DAS in Pharmaceutical Medicine (CAS/DAS: Certificate/Diploma of Advanced Studies provided by the University of Basel) | classroom training / eLearning | 28. 09. 2018 | cont. |
| Inselspital Bern, Universitätsklinik für Viszerale Chirurgie und Medizin Bereich Hepatologie (G.Stirnimann) | Investigator | GCP Training for Investigators | 03. 12. 2015 | cont. | |
| Klinik Hirslanden (CTU), Zurich | Investigator | GCP Basic Training Module 1 und 2 | on site classroom training | 20. 12. 2016 | cont. |
| SAKK - Swiss Group for Clinical Cancer Research | Investigator | SAKK Investigator's Education | on site classroom training | 12. 10. 2015 | cont. |
| School for Translation and Entrepreneurship in Medicine, University of Bern and siteminsel, Bern | Investigator and Sponsor-Investigator | Clinical Trial and Performance | classroom training / eLearning | 13. 10. 2022 | cont. |
| Schweizer Paraplegiker-Zentrum (CTU), Nottwil | Investigator and Sponsor-Investigator | GCP Kurs Investigator & Sponsor-Investigator Level | on site classroom training | 09. 03. 2017 | cont. |
| Schweizer Paraplegiker-Zentrum (CTU), Nottwil | GCP Refresher | GCP Refresher | classroom training / eLearning | 09. 04. 2020 | cont. |
| SPOG | GCP Refresher | SPOG GCP Refresher Course | on site classroom training | 10. 05. 2020 | cont. |
| Swiss Tropical and Public Health Institute (Swiss TPH) | Investigator | Good Clinical Practice (GCP) Training for Investigators and Study Teams | on site classroom training | 05. 07. 2016 | cont. |
| Swiss Tropical and Public Health Institute (Swiss TPH) | GCP Refresher | Good Clinical Practice (GCP) Refresher Kurs | on site classroom training | 04. 01. 2024 | cont. |
| TRREE | Investigator | Training and resources in research ethics evaluation (mandatory module 1, 2, 3, 4 and the national supplement Switzerland). | self-study eLearning | 27. 03. 2024 | cont. |
| Universität Basel, Departement Klinische Forschung (DKF) | Sponsor-Investigator | GCP Aufbaukurs | classroom training / eLearning | 17. 12. 2017 | cont. |
| Universität Basel, Departement Klinische Forschung (DKF) | Investigator | GCP Basiskurs | classroom training / eLearning | 16. 12. 2015 | cont. |
| Universität Basel, Departement Klinische Forschung (DKF) | GCP Refresher | GCP Refresher | self-study eLearning | 24. 06. 2020 | cont. |
| Universität Luzern, Departement Gesundheitswissenschaften und Medizin | Investigator and Sponsor-Investigator | Forschung am Menschen, BSc Gesundheitswissenschaften | on site classroom training | 12. 10. 2022 | cont. |
| Université de Neuchâtel Institut de droit de la santé | Investigator | Droit et progrès médical : Encadrement de la recherche impliquant des êtres humains | on site classroom training | 02. 12. 2021 | cont. |
| Veranex Switzerland SA | Investigator and Sponsor-Investigator | ISO14155:2020 Clinical Investigation of medical devices for human subjects - GCP (not valid for trials of pharmaceutical products (IMP) | on site classroom training | 21. 06. 2021 | cont. |
Cours d'éthique de la recherche et GCP qui ne sont plus reconnus par swissethics
Les cours GCP suivants ne sont plus reconnus. Tous les certificats GCP délivrés par les prestataires de cours suivants pendant la période de validité indiquée dans le tableau restent valables. swissethics recommande vivement que les connaissances soient maintenues par des activités de recherche régulières, par exemple par la réalisation d'essais cliniques, en participant à des formations continues liées à la recherche ou à des cours de rafraîchissement en GCP, en étant exposé à des inspections GCP etc. Les commissions d'éthique peuvent demander aux investigateurs de suivre un nouveau cours GCP si elles estiment que les connaissances n'ont pas été maintenues.
Les prestataires de cours peuvent demander la reconnaissance de leurs cours par swissethics en fonction des nouveaux objectifs de formation.
| Organisation | Recognised for | Course title | Date recognised | End validity period | Recognised by |
|---|---|---|---|---|---|
| ANMCO Research Center - Fondazione per il Tuo Cuore - HCF Onlus, Firenze, Italy | Investigator and Sponsor-Investigator | Good Clinical Practice | 26. 01. 2016 | 26.05.2021 | swissethics |
| AO Clinical Investigation and Documentation (AOCID) | Investigator and Sponsor-Investigator | AOCSC training program Investigator course / Subinvestigator course | 25. 02. 2011 | 31.12.2015 | Swissmedic |
| AO Clinical Investigation and Documentation (AOCID) - AO Foundation | Co-Investigator | Study Coordinators Course (Version 2.1) | 13. 09. 2013 | 31.12.2015 | Swissmedic |
| Clinipace AG (vorher PFC Pharma Focus AG), 8604 Volketswil | Subinvestigator and investigator | Training Requirements Investigator / Training Requirements Sub-Investigator | 11. 12. 2009 | 31.12.2015 | Swissmedic |
| Covance Clinical Research Unit AG | Co-Investigator | GCP Training |
09. 12. 2009 21. 10. 2011 |
31.12.2015 | Swissmedic |
| CRC Genève | Investigator and Sponsor-Investigator | Bonne Pratiques des Essais Cliniques (BPEC). | 03. 12. 2015 | 9.8.2021 | swissethics |
| CRC Genève | Investigator and Subinvestigator and Sponsor-investigator | Cours Bonnes Pratiques des Essais Cliniques | 13. 01. 2010 | 31.12.2015 | Swissmedic |
| CRC Genève | Co-Investigator | Cours BPEC Online Niveau Co-Investigateurs HUG | 04. 04. 2012 | 31.12.2015 | Swissmedic |
| CRC Genève | Investigator and Subinvestigator and Sponsor-investigator | Course Bonne Pratiques des Essais Cliniques | 30. 06. 2014 | 31.12.2015 | Swissmedic |
| CRC Genève (4AL) | Investigator and Subinvestigator and Sponsor-investigator | Certificate of Advanced Studies in Management of Clinical Trials / Good Clinical Practice Implementation and Quality Processes | 02. 05. 2012 | 31.12.2015 | Swissmedic |
| CTC Clinical Trial Consulting AG | Subinvestigator and investigator | GCP for Investigators // GCP for Sub-Investigatros | 10. 02. 2011 | 31.12.2015 | Swissmedic |
| CTC Zurich | Investigator and Subinvestigator and Sponsor-investigator | Good Clinical Practice GCP / Clinical Trial Management | 21. 12. 2009 | 31.12.2015 | Swissmedic |
| CTU Basel | Investigator and Sponsor-Investigator | Good Clinical Practice (GCP) für Investigator/Study Manager Basiskurs // Good Clinical Practice (GCP) für Sponsor-Investigator Aufbaukurs | 20. 02. 2012 | 31.12.2015 | Swissmedic |
| CTU Basel | Investigator and Subinvestigator and Sponsor-investigator | University Professional in Clinical Trial Practice and Management | 21. 12. 2009 | 31.12.2015 | Swissmedic |
| CTU Bern | Investigator and Subinvestigator and Sponsor-investigator | Clinical Investigators I:Basic GCP & clinical research training course // Clinical Investigators II: Advanced training course | 21. 12. 2009 | 31.12.2015 | Swissmedic |
| CTU Lausanne (course provided by Unil/EPFL - formation continue) | Investigator and Subinvestigator and Sponsor-investigator | Formation de base pour investigateurs cliniques (alternative title: Devenir investigateur clinique) | 16. 04. 2010 | 31.12.2015 | Swissmedic |
| CTU St. Gallen | Subinvestigator and investigator | GCP Kurs | 15. 02. 2010 | 31.12.2015 | Swissmedic |
| CTU Ticino EOC | Investigator and Subinvestigator and Sponsor-investigator | Modul 1 / Modul 2 /Modul 3 |
30. 04. 2013 08. 11. 2013 |
31.12.2015 | Swissmedic |
| DKF Basel | Investigator and Sponsor-Investigator | Clinical Research involving Children: Challenges and Opportunities | 12. 10. 2015 | 26.05.2021 | swissethics |
| ETH Zurich, Institute for Translational Medicine | Investigator | Ethik in der Forschung und GCP 1 und 2 (Note: the course was previously owned by ProWiMed GmbH, Zurich) | 13. 12. 2016 | 08.08.2022 | swissethics |
| European Center for Clinical Reserach Training (Kelecom) | Investigator | GCP full and refresher | 15. 09. 2014 | 31.12.2015 | swissethics |
| GlobalCompliancePanel - NetZealous, Fremont USA | Investigator and Sponsor-Investigator | GCP Module 3 | 27. 09. 2017 | 26.05.2021 | swissethics |
| Gnädinger Markus Dr. med. FMH | Co-Investigator | Good Clinical Practice - Kurse für Haus- und KinderärztInnen 2014 | 20. 12. 2013 | 31.12.2015 | Swissmedic |
| Hausärzte (M.Gnädinger, J. Lustenberger, R.Grossmann) | Co-Investigator | GCP | 07. 03. 2014 | 31.12.2015 | swissethics |
| HSeT Foundation | Investigator and Subinvestigator and Sponsor-investigator | PharmaTrain CLIC | 30. 04. 2012 | 31.12.2015 | Swissmedic |
| Infonetica Ltd.: GCP Training (J. Pouget, UK) | Investigator | GCP Online Training | 23. 03. 2014 | 31.12.2015 | swissethics |
| Inselspital Bern (A. Ayukebi) | Co-Investigator | GCP Basiswissen | 15. 04. 2014 | 31.12.2015 | swissethics |
| Inselspital Bern (G.Stirnimann) | Investigator | GCP Training for Investigators | 24. 11. 2014 | 31.12.2015 | swissethics |
| IPAS | Subinvestigator and investigator | Corsi di formazione GCP | 08. 10. 2010 | 31.12.2015 | Swissmedic |
| Klinische Forschung Aargau AG | Investigator | GCP-Schulung für Investigator | 17. 02. 2010 | 31.12.2015 | Swissmedic |
| Novipart Health & Life Sciences, 3967 Vercorin | Subinvestigator and investigator | GCP Training for investigator / GCP Training for sub-investigator | 16. 04. 2010 | 31.12.2015 | Swissmedic |
| Pierrel Research Switzerland AG | Co-Investigator | GCP-Schulungen | 13. 08. 2010 | 31.12.2015 | Swissmedic |
| PMC-Support / PTS Training Service University Childrens Hospital Zurich | Co-Investigator | Basiswissen und das neue Humanforschungsgesetz (Version 02 vom 05.12.2013) | 20. 12. 2013 | 31.12.2015 | Swissmedic |
| Rita Walt Consulting GmbH | Subinvestigator and investigator | RWConsulting Seminare 1 oder 2-tägiges GCP Training | 08. 11. 2010 | 31.12.2015 | Swissmedic |
| SAKK | Subinvestigator and investigator | SAKK Investigators Education |
20. 12. 2009 17. 02. 2010 |
31.12.2015 | Swissmedic |
| SCHMID CONSULT | Investigator | GCP For The Investigator | 30. 04. 2010 | 31.12.2015 | Swissmedic |
| School for Translation and Entrepreneurship in Medicine, University of Bern and siteminsel, Bern | Investigator and Sponsor-Investigator | Clinical Trial and Performance | 21. 11. 2018 | 26.05.2021 | swissethics |
| SENDO TECH S.r.l. | Subinvestigator and investigator | Good Clinical Practice for Sub-Investigator |
14. 06. 2011 28. 09. 2011 |
31.12.2015 | Swissmedic |
| SwAPP | Co-Investigator | How2GCP (online) | 28. 06. 2010 | 31.12.2015 | Swissmedic |
| Swiss Tropical and Public Health Institute (Swiss TPH) | Subinvestigator and investigator | Introduction to Good Clinical Practice (GCP) | 18. 05. 2010 | 31.12.2015 | Swissmedic |
| TRREE | Investigator | TRREE, Training and Resources in Research Ethics Evaluation (mandatory module 1, 2.1, 3.1, 3.2, and the national supplement Switzerland). | 14. 12. 2015 | 13.02.2024 | swissethics |
| Universität Luzern (A. Gemperli) | Co-Investigator | GCP-Training | 08. 01. 2015 | 31.12.2015 | swissethics |
| Universitätsspital Basel, Clinical Trial Unit | Investigator and Subinvestigator and Sponsor-investigator | Good Clinical Practice für Prüfärzte und Studienpersonal in der Pädiatrie | 07. 07. 2011 | 31.12.2015 | Swissmedic |
| Universitätsspital Basel, Departement Chirurgie | Subinvestigator and investigator | Basiskurs klinisch-chirurgische Forschung | 13. 08. 2010 | 31.12.2015 | Swissmedic |
| Universitätsspital Basel, Neurologische Klinik und Polyklinik | Investigator and Subinvestigator and Sponsor-investigator | Modul 1 / Modul 2 / Modul 3 | 16. 05. 2011 | 31.12.2015 | Swissmedic |
| Université de Genève (D.Haller. SSMI) | Subinvestigator and investigator | GCP pour médecins de ville | 26. 04. 2014 | 31.12.2015 | swissethics |
| Université de Neuchâtel Institut de droit de la santé | Investigator | CAS 3, Recherche, innovation et protection de données. Ethique de la recherche et LRH | 27. 03. 2019 | 26.05.2021 | swissethics |
| Université de Neuchâtel, Institut de droit de la santé | Subinvestigator and investigator | TRREE Module 3.2 GCP | 08. 10. 2012 | 31.12.2015 | Swissmedic |