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[ 554SIMTEHKK25 ] KV Ethics Committee
Versionsauswahl
Workload Education level Study areas Responsible person Hours per week Coordinating university
0,5 ECTS M1 - Master's programme 1. year (*)Medical Engineering Martin Ziermayr 0,5 hpw Johannes Kepler University Linz
Detailed information
Original study plan Master's programme Medical Engineering 2026W
Learning Outcomes
Competences
• The participants have an overview of the historical development and the legal basis, the structure and composition and the tasks of an ethics committee.

• Students know the key points for submitting a clinical study to an EC in principle.

Skills Knowledge
• Reproduce and understand the historical development, the legal basis, the structure and composition as well as the tasks of an ethics committee. (k1-k3)

• Write an (exemplary) application to the local EC for the authorisation of a clinical trial of a new medical device. (k1-k3)

• Historical development

• Legal basis

• Structure and composition of an EC

• Tasks of an EC

• Key points for submission: Focus on medical device studies (including software)

• Submission of Bachelor's/Master's theses

Criteria for evaluation Compulsory attendance at the first and second lectures. Alternatively, a written assignment (practical example) can be submitted for the second lecture.
Methods Lecture with practical example as homework
Language German
Study material
  • Austrian Drug Law (AMG 2022)
  • Medical Device Law (MPG 2021)
  • Clinical Trial Regulation (EU-VO 536/2014)
  • Medical Device Regulation (EU-VO 745/2017)
  • AI-Act (EU-VO 2024/1689)
  • Oö. Krankenanstaltengesetz (OöKAG)
  • Declaration of Helsinki, 2013
  • ICH-GCP E6 (R2)
  • DIN EN ISO 14155
  • EC-submission guidance for students
Changing subject? No
Earlier variants They also cover the requirements of the curriculum (from - to)
554SIMTEHKK22: KV Ethics Committee (2022W-2025S)
On-site course
Maximum number of participants -
Assignment procedure Assignment according to sequence