Safety Management in Clinical Research I and II
This online training provides you with an overview of definitions, requirements and procedures related to safety management in clinical research. The course content focusses on the specific requirements in Switzerland.
Topics:
- Legal and regulatory framework of safety reporting
- Assessment of adverse events
- Documentation and reporting of adverse events
- Safety and protective measures
- Annual Safety and Progress Reports
Different types of studies defined by the Human Research Act (HRA) are covered in two different courses:
Course 1: Safety Management in Clinical Research I
- Clinical trials with medicinal products
- Other clinical trials
- Human research projects
Course 2: Safety Management in Clinical Research II
- Clinical trials with medical devices
| Course language: | English |
| Duration: | approx 90 min. / each course, depending on previous knowledge and personal needs |
| Next Start: | online course, to be completed at every time and at own pace |
Online course that can be completed at your own pace at any time through self-study.
The courses consist of an online training module each. At the end of each course, acquired competencies will be checked by an online quiz.
Duration: approx. 90 min / each course
This course is open for everyone interested in Safety in Swiss clinical research.
It is especially appropriate for people working in clinical research either in academia or in industry (investigators, study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.) and would like to extend their expertise in the area of safety management (assessment, documentation, and reporting of safety events) in clinical research.
The course is free of charge.
Directors of Studies:
- Verena Golz, PhD
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
- After successful completion of the online quiz, certificates of attendance will be issued electronically.
- This course is the product of a collaboration by the Safety and Education platforms of the Swiss Clinical Trial Organisation (SCTO). It was prepared by the Clinical Trial Unit (CTU) Basel, in collaboration with all CTUs & the Swiss Group for Clinical Cancer Research (SAKK).
- This online training does not replace any GCP training. It must be regarded as a supplement to a GCP course to deepen or refresh knowledge on the topic of «safety management in clinical research».
Please register here.
Medical Faculty of the University of Basel