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Basics of Human Medical Research

Daten

Offizielle Daten in der Fachveröffentlichung für das folgende akademische Jahr: 2025-2026

Lehrbeauftragte/r

Semesterwochenstunden

Vorlesungen: 12

Praktika: 0

Seminare: 0

Insgesamt: 12

Fachangaben

  • Kode des Kurses: OBF-EVK-T
  • 1 kredit
  • Biotechnology MSc
  • Optional modul
  • autumn
Voraussetzungen:

keine

Zahl der Kursteilnehmer für den Kurs:

min. 5 – max. 20

Thematik

During the course, students learn about planning medical research on human subjects, including clinical trial protocol, research execution, and closure. In addition to the theoretical foundations, students will be able to conduct their mini-project and contribute to a real data collection program. The course provides basic knowledge to students who plan to be involved in human studies during their academic work or in future practice.

Vorlesungen

  • 1.

    Introduction. Current affairs, scheduling, and basic concepts of research on human subjects.

    - Zagorácz Olga
  • 2.

    Project plan. Collection of demographic data. Encryption.

    - Zagorácz Olga
  • 3.

    Clinical trial design and preparation.

    - Zagorácz Olga
  • 4.

    Patient information and informed consent.

    - Sziládiné Fusz Katalin
  • 5.

    Ethical and legal issues of clinical trials.

    - Sziládiné Fusz Katalin
  • 6.

    Ethical approval.

    - Sziládiné Fusz Katalin
  • 7.

    Quality assurance. ISOs.

    - Zelena Dóra Tímea
  • 8.

    Experimental data collection.

    - Zelena Dóra Tímea
  • 9.

    Closure of clinical trials. Data processing.

    - Csölle Ildikó Gabriella
  • 10.

    Data presentation.

    - Zelena Dóra Tímea
  • 11.

    The overview of current situation of the medical research on human subjects in Hungary and around the world.

    - Csölle Ildikó Gabriella
  • 12.

    Project presentation

    - Zagorácz Olga

Praktika

Seminare

Materialien zum Aneignen des Lehrstoffes

Obligatorische Literatur

Vom Institut veröffentlichter Lehrstoff

Ppt-s available in Teams group

Skript

Empfohlene Literatur

"Good clinical practice" guidelines
Stephen Glasser "Introduction to clinical research and study designs"

Voraussetzung zum Absolvieren des Semesters

Project presentation

Semesteranforderungen

No

Möglichkeiten zur Nachholung der Fehlzeiten

Oral report

Prüfungsfragen

Project presentation

Prüfer

  • Sziládiné Fusz Katalin
  • Zagorácz Olga
  • Zelena Dóra Tímea

Praktika, Seminarleiter/innen

  • Csölle Ildikó Gabriella
  • Sziládiné Fusz Katalin
  • Zagorácz Olga
  • Zelena Dóra Tímea
Rólunk