GCP-Kurse

List of swissethics recognised Research Ethics and GCP course providers

As of 1 May 2017, the integrated addendum to the GCP guidelines E6(R2) is applicable in Switzerland. The researchers that have not taken a course on the ICH E6(R2) yet, can study the new guidelines – with highlighted changes – here.

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.

An Investigator can assume the role and responsiblities of the Sponsor in a sponsor-investigator clinical trial if he or she has taken both the "Investigator" and the "Sponsor-Investigator" training modules. The training module "Sponsor-Investigator" is only valid and it is only offered to the candidates that have also previously taken a recognised module "Investigator".

The candidates are advised to consult directly with the course provider to know which training module he or she must take to comply to the requirements. This because some course providers offer stand-alone training modules for "Sponsor-Investigator", and other course providers offer both modules ("Investigator" and "Sponsor-investigator") in one single course.

The Ethics Committees can request the researchers to re-take a GCP course, if the Ethics Committees consider the knowledge has not been maintained.

last updated: 14. 02. 2022

Organisation	Recognised for	Course title	Date recognised	Validity
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
AO Foundation, AO Program for Education and Excellence in Research (AOPEER)	Investigator	Study management and Good Clinical Practice	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	17. 12. 2015	cont.
Berner Fachhochschule, BFH, Fachbereich Gesundheit	Investigator and Sponsor-Investigator	CAS Clinical Research Coordinator	21. 02. 2017	cont.
CRC Genève	Investigator and Sponsor-Investigator	DAS Diploma of Advanced Studies - Management of Clinical Trials, Good Clinical Practice Implementation and Quality Processes	03. 12. 2015	cont.
CRC Genève	Investigator and Sponsor-Investigator	Bonne Pratiques des Essais Cliniques (BPEC). This course is no longer offered. The certificates remain valid.	03. 12. 2015	cont.
CRC Genève	Investigator	Bonne Pratiques des Essais Cliniques niveau I (pour les investigateurs, e-Learning): BPEC I	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	MAS Master of Advanced Studies - Drug Discovery and Clinical Developement	13. 04. 2016	cont.
CROss research S.A. / CROss Alliance, Mendrisio	Investigator	Research Ethics and GCP	06. 02. 2017	cont.
CTC Zurich	Investigator	GCP courses Module 1, 2	09. 12. 2015	cont.
CTC Zurich	Investigator and Sponsor-Investigator	CAS Clinical Trial Management	09. 12. 2015	cont.
CTC Zurich	Investigator and Sponsor-Investigator	GCP courses Module 3	09. 12. 2015	cont.
CTU & IUMSP Lausanne (CHUV & FBM-Unil), 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 Basel	Investigator and Sponsor-Investigator	GCP Aufbaukurs	17. 12. 2017	cont.
CTU Basel	Investigator	GCP Basiskurs	16. 12. 2015	cont.
CTU Basel	Investigator and Sponsor-Investigator	Clinical Research involving Children: Challenges and Opportunities	12. 10. 2015	26.05.2021
CTU Basel	GCP Refresher	GCP Refresher	24. 06. 2020	cont.
CTU Bern	GCP Refresher	GCP Refresher	15. 09. 2020	cont.
CTU Bern	Investigator and Sponsor-Investigator	Clinical Investigator II: Advanced GCP & clinical research training	10. 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	10. 12. 2015	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 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 St. Gallen	GCP Refresher	GCP Refresher	30. 01. 2020	cont.
CTU St. Gallen	Investigator	GCP	08. 12. 2015	cont.
EOC CTU Bellinzona	Investigator and Sponsor-Investigator	Research Ethics and GCP	08. 12. 2015	cont.
EOC CTU Bellinzona	GCP Refresher	GCP Refresher	19. 09. 2019	cont.
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	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)	28. 09. 2018	cont.
GlobalCompliancePanel - NetZealous, Fremont USA	Investigator and Sponsor-Investigator	GCP Module 3	27. 09. 2017	26.05.2021
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	20. 12. 2016	cont.
Medidee Services SA, Lausanne	Investigator and Sponsor-Investigator	ISO14155:2020 Clinical Investigation of medical devices for human subjects - GCP (not valid for trials of pharmaceutical products (IMP)	21. 06. 2021	cont.
SAKK - Swiss Group for Clinical Cancer Research	Investigator	SAKK Investigator's Education	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	21. 11. 2018	26.05.2021
Schweizer Paraplegiker-Zentrum (CTU), Nottwil	GCP Refresher	GCP Refresher	09. 04. 2020	cont.
Schweizer Paraplegiker-Zentrum (CTU), Nottwil	Investigator and Sponsor-Investigator	GCP Kurs Investigator & Sponsor-Investigator Level	09. 03. 2017	cont.
SPOG	GCP Refresher	SPOG GCP Refresher Course	10. 05. 2020	cont.
Swiss Tropical and Public Health Institute (Swiss TPH)	Investigator	Good Clinical Practice (GCP) Training for Investigators and Study Teams	05. 07. 2016	cont.
TRREE	Investigator	TRREE, Training and Resources in Research Ethics Evaluation (mandatory module 1, 2.1, 3.1, 3.2, and the national supplement Switzerland). (e-Learning)	14. 12. 2015	cont.
Université de Neuchâtel Institut de droit de la santé	Investigator	Droit et progrès médical : Encadrement de la recherche impliquant des êtres humains	02. 12. 2021	cont.
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

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 before 31 December 2015 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	Recognised by
AO Clinical Investigation and Documentation (AOCID)	Investigator and Sponsor-Investigator	AOCSC training program Investigator course / Subinvestigator course	25. 02. 2011	Swissmedic
AO Clinical Investigation and Documentation (AOCID) - AO Foundation	Co-Investigator	Study Coordinators Course (Version 2.1)	13. 09. 2013	Swissmedic
Clinipace AG (vorher PFC Pharma Focus AG), 8604 Volketswil	Subinvestigator and investigator	Training Requirements Investigator / Training Requirements Sub-Investigator	11. 12. 2009	Swissmedic
Covance Clinical Research Unit AG	Co-Investigator	GCP Training	09. 12. 2009 21. 10. 2011	Swissmedic
CRC Genève	Investigator and Subinvestigator and Sponsor-investigator	Course Bonne Pratiques des Essais Cliniques	30. 06. 2014	Swissmedic
CRC Genève	Investigator and Subinvestigator and Sponsor-investigator	Cours Bonnes Pratiques des Essais Cliniques	13. 01. 2010	Swissmedic
CRC Genève	Co-Investigator	Cours BPEC Online Niveau Co-Investigateurs HUG	04. 04. 2012	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	Swissmedic
CTC Clinical Trial Consulting AG	Subinvestigator and investigator	GCP for Investigators // GCP for Sub-Investigatros	10. 02. 2011	Swissmedic
CTC Zurich	Investigator and Subinvestigator and Sponsor-investigator	Good Clinical Practice GCP / Clinical Trial Management	21. 12. 2009	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	Swissmedic
CTU Basel	Investigator and Subinvestigator and Sponsor-investigator	University Professional in Clinical Trial Practice and Management	21. 12. 2009	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	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	Swissmedic
CTU St. Gallen	Subinvestigator and investigator	GCP Kurs	15. 02. 2010	Swissmedic
CTU Ticino EOC	Investigator and Subinvestigator and Sponsor-investigator	Modul 1 / Modul 2 /Modul 3	30. 04. 2013 08. 11. 2013	Swissmedic
European Center for Clinical Reserach Training (Kelecom)	Investigator	GCP full and refresher	15. 09. 2014	swissethics
Gnädinger Markus Dr. med. FMH	Co-Investigator	Good Clinical Practice - Kurse für Haus- und KinderärztInnen 2014	20. 12. 2013	Swissmedic
Hausärzte (M.Gnädinger, J. Lustenberger, R.Grossmann)	Co-Investigator	GCP	07. 03. 2014	swissethics
HSeT Foundation	Investigator and Subinvestigator and Sponsor-investigator	PharmaTrain CLIC	30. 04. 2012	Swissmedic
Infonetica Ltd.: GCP Training (J. Pouget, UK)	Investigator	GCP Online Training	23. 03. 2014	swissethics
Inselspital Bern (A. Ayukebi)	Co-Investigator	GCP Basiswissen	15. 04. 2014	swissethics
Inselspital Bern (G.Stirnimann)	Investigator	GCP Training for Investigators	24. 11. 2014	swissethics
IPAS	Subinvestigator and investigator	Corsi di formazione GCP	08. 10. 2010	Swissmedic
Klinische Forschung Aargau AG	Investigator	GCP-Schulung für Investigator	17. 02. 2010	Swissmedic
Novipart Health & Life Sciences, 3967 Vercorin	Subinvestigator and investigator	GCP Training for investigator / GCP Training for sub-investigator	16. 04. 2010	Swissmedic
Pierrel Research Switzerland AG	Co-Investigator	GCP-Schulungen	13. 08. 2010	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	Swissmedic
Rita Walt Consulting GmbH	Subinvestigator and investigator	RWConsulting Seminare 1 oder 2-tägiges GCP Training	08. 11. 2010	Swissmedic
SAKK	Subinvestigator and investigator	SAKK Investigators Education	20. 12. 2009 17. 02. 2010	Swissmedic
SCHMID CONSULT	Investigator	GCP For The Investigator	30. 04. 2010	Swissmedic
SENDO TECH S.r.l.	Subinvestigator and investigator	Good Clinical Practice for Sub-Investigator	14. 06. 2011 28. 09. 2011	Swissmedic
SwAPP	Co-Investigator	How2GCP (online)	28. 06. 2010	Swissmedic
Swiss Tropical and Public Health Institute (Swiss TPH)	Subinvestigator and investigator	Introduction to Good Clinical Practice (GCP)	18. 05. 2010	Swissmedic
Universität Luzern (A. Gemperli)	Co-Investigator	GCP-Training	08. 01. 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	Swissmedic
Universitätsspital Basel, Departement Chirurgie	Subinvestigator and investigator	Basiskurs klinisch-chirurgische Forschung	13. 08. 2010	Swissmedic
Universitätsspital Basel, Neurologische Klinik und Polyklinik	Investigator and Subinvestigator and Sponsor-investigator	Modul 1 / Modul 2 / Modul 3	16. 05. 2011	Swissmedic
Université de Genève (D.Haller. SSMI)	Subinvestigator and investigator	GCP pour médecins de ville	26. 04. 2014	swissethics
Université de Neuchâtel, Institut de droit de la santé	Subinvestigator and investigator	TRREE Module 3.2 GCP	08. 10. 2012	Swissmedic