Management of Clinical Trials - Clinical Trials Conduct and Close-out (2025)

Micro-credential

The micro-credentialed Short course Clinical Trials Conduct and Close-out corresponds to module 8 of the DAS in Management of Clinical Trials.

• Develop strategies for effective recruitment and retention of study subjects.
• Manage randomisation and blinding systems to ensure study integrity.
• Implement robust data collection and management practices.
• Oversee the management of investigational medicinal products throughout the trial.
• Conduct effective risk-based monitoring of clinical studies to ensure compliance and data quality.
• Perform close-out activities in accordance with regulatory requirements and study protocols.
• Oversee central laboratories and different services.
• Develop and execute statistical analysis plans for clinical trial data.
• Perform data cleaning and database lock procedures to ensure data accuracy and integrity.
• Prepare comprehensive clinical study reports documenting study outcomes.
• Conduct safety reconciliation processes to ensure accurate safety reporting.

Professionals engaged in clinical trial conduct and close-out activities, including clinical research coordinators, project managers, data managers, monitors, and individuals responsible for ensuring study completion and data integrity.

• Skill in managing randomisation and blinding processes to maintain study integrity.
• Competence in data collection, management, and validation procedures.
• Managing investigational medicinal products throughout the trial lifecycle.
• Ability to conduct effective risk-based monitoring visits and ensure study compliance.
• Competence in conducting close-out activities and finalising study documentation.
• Ability to oversee central laboratory activities and other services.
• Understanding of data cleaning and database lock procedures.
• Ability to prepare comprehensive clinical study reports in compliance with regulatory requirements.
• Competence in safety reconciliation processes to ensure accurate safety reporting throughout the trial.

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM).

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)

• 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

• 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

• Copy of identity document
• Passport photo
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter
• Two reference letters
• Written authorisation from their employer, if applicable