Micro-credential

This Micro-credential Short Course Clinical Trial Conduct and Close-out​ corresponds to module 8 of the DAS in Management of Clinical Trials.

Overview

Objectives

  • 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.

Audience

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.

Learning outcomes

  • 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.

Registration

Registration deadline

12 January 2026

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 ÓñÃÀÈË´«Ã½ 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
  • Curriculum Vitae
  • Copies of relevant university degrees
  • Covering letter

Curriculum

Period

9 February 2026 - 11 February 2026

Teaching hours

24 teaching hours

Microcertification

2 ECTS credits
: 7

Assessment

Multiple Choice Questions (MCQ)

Intervenant-es

  • Dr Cécile NICOLAS-DENIZOU
  • Dr Niloufar MARSOUSI

Partnerships / Collaboration

Accreditation / Recognition / Certification

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).

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, ÓñÃÀÈË´«Ã½

Coordinator(s)

Prof. François CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, ÓñÃÀÈË´«Ã½

Steering committee

  • Prof. , President of the Section of Pharmaceutical Sciences (ISPOS), Faculty of Science, ÓñÃÀÈË´«Ã½
  • Prof Alexandra CALMY, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Dept of Infectious Diseases, Geneva ÓñÃÀÈË´«Ã½ Hospitals
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Prof , Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Dr , President, Catonal Commission on Human Research Ethics, Canton of Geneva
  • Prof Klara POSFAY BARBE, Medical Director, Geneva ÓñÃÀÈË´«Ã½ Hospitals

Scientific committee

  • ¶Ù°ùÌý, Senior Director Clinical Affairs, FIND
  • Dr , Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
  • ±Ê°ù´Ç´Ú.Ìý, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), Lecturer at Geneva ÓñÃÀÈË´«Ã½ Hospitals, ÓñÃÀÈË´«Ã½
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • ¶Ù°ùÌý, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof Jules DESMEULES, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Prof , Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
  • Dr , Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at ÓñÃÀÈË´«Ã½ of Bern
  • Dr , External Consultant
  • Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC), Geneva ÓñÃÀÈË´«Ã½ Hospitals
  • Dr , External Consultant
  • Dr , PhD, Lead Patient Engagement, Novartis, Basel
  • ¶Ù°ùÌý, PharmD, Division of Clinical Pharmacology and Toxicology, ÓñÃÀÈË´«Ã½ Hospitals of Geneva and Faculty of Medicine, ÓñÃÀÈË´«Ã½

Contribution to the Sustainable Development Goals