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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 2025W
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 participation in the first LVA or alternatively the submission of the written homework (practical example)
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