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Education

Basics of Human Medical Research

Data

Official data in SubjectManager for the following academic year: 2025-2026

Course director

Number of hours/semester

lectures: 12 hours

practices: 0 hours

seminars: 0 hours

total of: 12 hours

Subject data

  • Code of subject: OPF-EVK-T
  • 1 kredit
  • Pharmacy
  • Optional modul
  • autumn
Prerequisites:

-

Course headcount limitations

min. 5 – max. 20

Topic

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.

Lectures

  • 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

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Ppt-s available in Teams group

Notes

Recommended literature

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

Conditions for acceptance of the semester

Project presentation

Mid-term exams

No

Making up for missed classes

Oral report

Exam topics/questions

Project presentation

Examiners

  • Sziládiné Fusz Katalin
  • Zagorácz Olga
  • Zelena Dóra Tímea

Instructor / tutor of practices and seminars

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