Online Course: Quality Management in Clinical Research
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.
| Course language: | English |
| Duration: | 5 chapters to work through at your own pace |
| Next Start: | Online, at any time |
| Workload: | 1-2h |
This course can be completed online at any time through self-study and at your own pace.
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.
The course is free of charge.
Course lead:
Dr. Sandra Kohlmaier, Senior Research Associate, Training and Education, Department of Clinical Research (DKF) Basel
Mareike Gräter
Training and Education
Department Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel
mareike.graeter@clutterusb.ch
Tel. +41 61 556 59 76
Please register here.
Medical Faculty of the University of Basel, Department of Clinical Research (DKF) Basel