Safety Management in Clinical Research
Weiterbildungskurs

This online training will provide you with an overview of definitions, requirements and procedures related to safety management in clinical research.

Topics:

  • Legal and regulatory framework of safety reporting
  • Assessment of adverse events
  • Documentation and reporting of adverse events
  • Safety and protective measures
  • Annual Safety 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

  • Clinical trials with medicinal products
  • Other clinical trials
  • Human research projects

Course 2: Safety Management in Clinical Research

  • Clinical trials with medical devices

This course has been updated according to the new regulations on clinical trials with medical devices, which came into force on 26 May 2021.

You will find more information about the MDR revision here.

This 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

People working in clinical research either in academia or in industry (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) from the perspective as a clinical investigator.

  • Dr. Verena Golz

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

verena.golz@usb.ch
Phone +41 61 328 51 47
Training and Education Departement of Clinical Research

Available Mon, Wed, Thu

Free of charge

Medical Faculty of the University of Basel

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).

Course language: English

After successful completion of the online quiz, certificates will be issued electronically.

This online training does not replace any GCP training. It must be regarded as a supplement to a GCP course in order to deepen or refresh knowledge on the topic of "safety management in clinical research".

Ort

University Hospital Basel Spitalstrasse 21, 4031 Basel


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