Micro-credential
This Micro-credential Short Course Clinical Trials Set-up and Conduct corresponds to module 7 of the DAS in Management of Clinical Trials.
Overview
Objectives
- Understand scientific, strategic, and safety considerations in clinical trial design.
- Develop budgets and plan resources effectively for clinical trials.
- Select appropriate investigator sites for trial implementation.
- Identify the role of Contract Research Organisations (CROs) and external providers in clinical trial management.
- Familiarise with essential clinical trial documents and their significance in trial conduct.
- Navigate the submission process to Swiss Ethics Committees (EC) and Regulatory Authorities (RA).
- Implement risk management strategies to ensure trial safety and compliance.
Audience
Learning outcomes
- Proficiency in designing clinical trials considering scientific, strategic, and safety aspects.
- Ability to develop and manage budgets for clinical trial operations.
- Skill in selecting investigator sites based on strategic criteria and operational feasibility.
- Understanding of the roles and responsibilities of CROs and external providers in clinical trial management.
- Competence in preparing and managing essential clinical trial documents.
- Proficiency in navigating the submission process to Swiss Ethics Committees and Regulatory Authorities.
- Ability to implement risk management strategies to mitigate potential risks during trial conduct.
Registration
Registration deadline
Fees:
CHF 1,800
Admission criteria
a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.
b) Good oral and written comprehension of English (equivalent to level B2-C1)
Application File
- Copy of identity document
- Passport photo (jpg format following these guidelines here)
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
Curriculum
Period
Teaching hours
Microcertification
Assessment
Intervenant-es
- Dr Shelly BUSTION
- Dr Sandrine CHARVAT
Partnerships / Collaboration
Accreditation / Recognition / Certification
Director(s)
Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva
Coordinator(s)
Steering committee
- Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, University of Geneva
- Prof. Alexandra CALMY, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Department of Infectious Diseases, Geneva University Hospitals
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Prof. Antoine GEISSBUHLER, Dean of the Faculty of Medicine, University of Geneva
- Dr Olivier HUBER, President, Cantonal Commission on Human Research Ethics, Canton of Geneva
- Prof. Samia HURST, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
- Prof. Arnaud PERRIER, Medical Director, Geneva University Hospitals
Scientific committee
- Dr Emilie ALIROL, Senior Director Clinical Affairs, FIND
- Dr Enrica ALTERI, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
- Prof. Francois CURTIN, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Geneva University Hospitals, University of Geneva
- Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
- Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development, Geneva
- Prof. Jules DESMEULES, Faculty of Medicine, University of Geneva
- Prof. Philippe DUCOR, Faculty of Law, University of Geneva
- Prof. Marc FROISSART, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
- Prof. Angèle GAYET-AGERON, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals, Faculty of Medecine, University of Geneva
- Prof. Angela HUTTNER, Associate Professor, Department of Infectious Diseases, Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Cyril JAKSIC, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals
- Dr Françoise LASCOMBES, External Consultant
- Dr Guillaume PERRIARD, PhD, Lead patient Engagement, Novartis, Basel
- Dr Victoria ROLLASON, Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, University of Geneva
Related programmes
- DAS - Management of Clinical Trials (2024)
- Session - Management of Clinical Trials – Ethical and Legal Aspects (2024)
- Session - Management of Clinical Trials – Clinical Trials Conduct and Close-out (2025)
- Session - Management of Clinical Trials – Medical Devices (2025)
- Session - Management of Clinical Trials – Audits and Inspections (2025)