Liste der von swissethics anerkannten Anbieter von Kursen zur Forschungsethik und GCP
swissethics empfiehlt dringend, dass das Fachwissen durch regelmässige Forschungsaktivität aufrechterhalten bleibt, z.B. durch die Durchführung klinischer Versuche, die Teilnahme an Weiterbildungskursen im Forschungsbereich oder an GCP Refresher Kursen. Auch können von extern GCP-Inspektionen in Institutionen oder Studienzentren durchgeführt werden.
Im Rahmen eines «Sponsor-Investigator» klinischen Versuchs können Prüfende (Investigatoren) die Rolle und Verantwortung von Sponsoren übernehmen, wenn sie beide Aus- und Weiterbildungsmodule absolviert haben, d.h. sowohl das Modul für Investigatoren, als auch dasjenige für Sponsor-Investigatoren. Das Weiterbildungsmodul für Sponsor-Investigatoren wird nur für Personen angeboten, die vorher ein anerkanntes Modul für Investigatoren absolviert haben.
Den Personen wird empfohlen, direkt mit dem Kursanbieter Kontakt aufzunehmen, um herauszufinden, welche Aus- und Weiterbildungsmodule sie abschliessen müssen, damit sie die Anforderungen erfüllen. Diese Abklärung ist nötig, weil einige Kursanbieter ein separates Modul für Sponsor-Investigatoren organisieren, während andere beide Module («Investigator» und «Sponsor-Investigator») in einem einzigen Kurs durchführen.
Die Ethikkommissionen können von Forschenden die Wiederholung einer GCP-Ausbildung verlangen, wenn sie der Meinung sind, dass das Wissen nicht adäquat für die Investigator- resp. Sponsor-Investigator-Aufgabe vorhanden ist.
last updated: 17. 11. 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. This course has been reviewed and endorsed by the Training Subcommittee of ICH. | self-study eLearning | 14. 04. 2024 | cont. |
| Berner Fachhochschule, BFH, Fachbereich Gesundheit | Investigator and Sponsor-Investigator | CAS Clinical Research Coordinator | classroom training / eLearning | 21. 02. 2017 | 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 | Bonne Pratiques des Essais Cliniques niveau I (pour les investigateurs, e-Learning): BPEC I | self-study eLearning | 12. 02. 2019 | 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 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 | Investigator | GCP | classroom training / eLearning | 08. 12. 2015 | cont. |
| CTU St. Gallen | GCP Refresher | GCP Refresher (CTU St. Gallen) | on site classroom training | 30. 01. 2020 | cont. |
| DCR Bern | Investigator and Sponsor-Investigator | Clinical Investigator (dentists) | 10. 12. 2015 | cont. | |
| DCR Bern | GCP Refresher | GCP Refresher (DCR Bern) | classroom training / eLearning | 15. 09. 2020 | cont. |
| DCR Bern | Investigator | Clinical Investigator I: Basic GCP & clinical research training | classroom training / eLearning | 10. 12. 2015 | cont. |
| DCR Bern | Sponsor-Investigator | Clinical Investigator II: Advanced GCP & clinical research training | classroom training / eLearning | 10. 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 | Investigator and Sponsor-Investigator | Research Ethics and GCP | on site classroom training | 08. 12. 2015 | cont. |
| EOC CTU Bellinzona | GCP Refresher | GCP Refresher (EOC CTU Bellinzona) | on site classroom training | 19. 09. 2019 | 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) | on site classroom training | 28. 09. 2018 | 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 | GCP Refresher | Refresher (SAKK) | on site classroom training | 17. 06. 2024 | 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 (CTU, Nottwil) | classroom training / eLearning | 09. 04. 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 modules 1, 2, 3, 4 and the Regulatory framework of Switzerland ("Swiss module")). | 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 (DKF Basel) | 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. |
| University of Geneva, Faculty of Medicine (UNIGE), Genève | Investigator and Sponsor-Investigator | MAS Master of Advanced Studies - Drug Discovery and Clinical Developement | classroom training / eLearning | 13. 04. 2016 | cont. |
| University of Geneva, Faculty of Medicine (UNIGE), Genève | Investigator and Sponsor-Investigator | DAS Diploma of Advanced Studies - Management of Clinical Trials | classroom training / eLearning | 03. 12. 2015 | 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. |
Research Ethics and GCP courses no more recognised by swissethics
The following GCP courses are no longer recognised. All GCP certificates issued by the following course providers during the period of validity indicated in the table remain valid. swissethics strongly recommends that the knowledge is maintained by regular research activity, e.g. by conducting clinical trials, attending continuing education related to research or GCP refresher courses, being exposed to GCP inspection etc. The Ethics Committees can request the researchers to re-take a GCP course, if the Ethics Committees consider the knowledge has not been maintained.
Course providers can apply for recognition of their courses by swissethics according to the new learning objectives.
| 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 |
| AO Foundation, AO Program for Education and Excellence in Research (AOPEER) | Investigator | Study management and Good Clinical Practice | 10. 04. 2019 | 09.10.2024 | swissethics |
| AO Foundation, Clinical Investigation and Documentation (AOCID) | Investigator | Good Clinical Practice course (Good Clinical Practice course for surgeons) | 21. 12. 2015 | 03.09.2024 | swissethics |
| Appletree CI Group AG | Investigator | The principles of clinical research in humans and GCP training for investigators | 17. 12. 2015 | 16.07.2024 | swissethics |
| 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 | 12.11.2024 | swissethics |
| 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 | 17.11.2024 | swissethics |
| 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 |
| Inselspital Bern, Universitätsklinik für Viszerale Chirurgie und Medizin Bereich Hepatologie (G.Stirnimann) | Investigator | GCP Training for Investigators | 03. 12. 2015 | 20.11.2024 | 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 |
| SAKK - Swiss Group for Clinical Cancer Research | Investigator | SAKK Investigator's Education | 12. 10. 2015 | 23.09.2024 | swissethics |
| 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 |
| SPOG | GCP Refresher | SPOG GCP Refresher Course | 10. 05. 2020 | 10.11.2024 | swissethics |
| 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 |