Quality Management in Clinical Research
Short Course

Overview

Degree
Kurs
Next start
at any time
Duration
5 chapters to work through at your own pace
Fee
free of charge
Language
Englisch
Note
online

This online course offers a practical introduction to quality management (QM) in clinical research. In five clearly structured chapters, participants learn about the key elements of a quality management system (QMS) and understand the role a QMS plays in ensuring the quality, safety and integrity of clinical trials. In addition, the course shows how a QMS can be set up with manageable effort, who is responsible for its implementation, and how the QMS solution ‘Orca’ from the Department of Clinical Research (DKF) Basel can help establish a quality management system that meets the regulatory requirements and framework conditions of academic research in Switzerland.

Further information:

Online Course: Quality Management in Clinical Research

The course consists of five modular online chapters. These enable participants to study flexibly, independently of time and place, in self-study sessions lasting approximately 1 to 2 hours. Interactive elements support knowledge building and continuous review of what has been learned.

Chapter 1: What is a QMS?
Introduction to quality management in clinical research: significance, key elements and advantages of a QMS.

Chapter 2: QMS in clinical research
Objectives of an effective QMS in clinical research, identification of critical processes and responsibilities – in particular the role of the sponsor.

Chapter 3: Tips for establishing and developing a QMS
Practical steps and recommendations for establishing and developing a QMS

Chapter 4: Orca – The digital QMS for clinical research
Presentation of the DKF Basel's ‘Orca’ QMS solution: Key functions and benefits of a digital quality management system.

Chapter 5: Support from the DKF
Overview of the support services offered by the DKF in the area of quality management

The course is open to all professionals in clinical research and other interested parties.

The course is specifically aimed at individuals working in clinical research (study physicians, study nurses, study coordinators, study managers, clinical research associates, etc.) who are interested in the topic of QMS in academic clinical research and the eQMS solution ‘Orca’ and would like to gain an initial overview.

  • Dr. Daniel Hammes, Studiengangleitung

Mareike Gräter
Training and Education
Departement of Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel

mareike.graeter@usb.ch
Tel. +41 61 556 59 76
Weiterbildungen Departement Klinische Forschung

Available Mon-Thu 08.30h - 13.30h

The course is free of charge.

Medical Faculty of the University of Basel

Organiser
Department of Clinical Research, University of Basel, c/o University Hospital Basel

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