AV短视频

Health

Short course Management of Clinical Trials 鈥� Clinical Trials Conduct and Close-out 2025

Micro-credential

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

Microcertification

Information

Period

17 February 2025 - 19 February 2025
2 ECTS credits (micro-credential)
24 Teaching hours
Personal working hours: 36

EQF-level

Language

English

Format

On-site

Contact


das-mas-clinical(at)unige.ch

Location

Geneva

Registration

Registration deadline

17 January 2025

Fees:

CHF 1,800

Contribution to the SDGs

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.

Director(s)

Prof. Youssef DAALI and Prof. Fran莽ois CURTIN, Faculty of Science and Faculty of Medicine, AV短视频

Coordinator(s)

Prof. Fran莽ois CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, AV短视频

Accreditation

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).

Assessment

Multiple Choice Questions (MCQ)

Admission criteria

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or聽a bachelor's degree in nursing from a Swiss AV短视频 of Applied Sciences;
or聽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)

Steering committee

  • Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, AV短视频
  • 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 AV短视频 Hospitals
  • Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Prof. Antoine GEISSBUHLER, Dean of the Faculty of Medicine, AV短视频
  • Dr聽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, AV短视频
  • Prof. Arnaud PERRIER, Medical Director, Geneva AV短视频 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 Z眉rich & Lecturer at Geneva AV短视频 Hospitals, AV短视频
  • Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
  • Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development, Geneva
  • Prof. Jules DESMEULES, Faculty of Medicine, AV短视频
  • Prof. Philippe DUCOR, Faculty of Law, AV短视频
  • Prof. Marc FROISSART, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
  • Prof. Ang猫le GAYET-AGERON, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals, Faculty of Medecine, AV短视频
  • Prof. Angela HUTTNER, Associate Professor, Department of Infectious Diseases, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Dr Cyril JAKSIC, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals
  • Dr Fran莽oise LASCOMBES, External Consultant
  • Dr Guillaume PERRIARD, PhD, Lead patient Engagement, Novartis, Basel
  • Dr Victoria ROLLASON, Division of Clinical Pharmacology and Toxicology, Geneva AV短视频 Hospitals and Faculty of Medicine, AV短视频

Application File

  • Copy of identity document
  • Passport photo (jpg format following these guidelines )
  • Curriculum Vitae
  • Copies of relevant university degrees
  • Covering letter
  • Dr C茅cile NICOLAS-DENIZOU
  • Dr Niloufar MARSOUSI

Contribution to the SDGs

Related programmes