DSCHCT Designing and Conducting Human Clinical Trials

Faculty of Medicine
autumn 2025
Extent and Intensity
0/0/0. 3 credit(s). Type of Completion: z (credit).
Teacher(s)
PharmDr. Zora Čechová, Ph.D. (seminar tutor)
Mgr. Kateřina Nebeská (seminar tutor)
PharmDr. Jitka Rychlíčková, Ph.D. (seminar tutor)
PharmDr. Lenka Součková, Ph.D. (seminar tutor)
Mgr. et Mgr. Petra Ošmerová (assistant)
Guaranteed by
PharmDr. Jitka Rychlíčková, Ph.D.
Department of Pharmacology – Theoretical Departments – Faculty of Medicine
Supplier department: Department of Pharmacology – Theoretical Departments – Faculty of Medicine
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
The target population of the subject are Ph.D. students, early-career researchers, investigators planning an academic clinical trial, persons starting to work in clinical trials, and teachers and lecturers of the theory of clinical trials
What can the participant gain?
- Knowledge, skills, and abilities on how to design, conduct, manage, evaluate, publish an investigator-initiated trial.
- Interdisciplinary skills in leadership, publishing, and teaching.
- Inspiration on how to organize classes online, and how to use materials available.

The course is delivered in an online format only in the academic year 2025/26. The independent study includes working on the training platform, watching recordings from the international online lessons, completing tasks.
Online consultations with the content experts will be possible to schedule during the semester on the as needed basis.
Learning outcomes
The student is able to:
- recognize and better understand the key issues associated with the design, conduct, management, evaluation and publication of non-commercial clinical trials.
- use gained knowledge in his/her own project planned.
- write/design basic documents accompanying a clinical trial and specific subtypes.
- present results of a clinical trial to different audiences – from a scientific paper to a lay’s summary, oral presentation.
- collaborate in virtual multinational teams with other students, teachers, researchers.
Syllabus
  • Videorecordings, lessons on the training platform:
  • - Clinical Trial Designs – Frances Shiely, University College Cork
  • - Early Phase Trials – Annamária Németh, University of Szeged
  • - Pediatric Clinical Trials – Kateřina Nebeská, Masaryk University
  • - Quality and regulatory affairs and sources of regulatory information – Zora Čechová, Masaryk University
  • - Trial Management – Joana Batuca, Sara Maia, Universidade NOVA de Lisboa
  • - Data management and statistical analysis – Gábor Kovács, University of Pécs
  • - Pharmacovigilance and study medication – Frances Shiely, University College Cork, Lenka Součková, Jitka Rychlíčková, Masaryk University
  • - Trial Methodology – Frances Shiely, University College Cork
  • - Medical Devices – Annamária Németh, University of Szeged
  • - Leadership for PIs – Viktória Nagy, Université Paris Cité
  • - Open research and scientific publishing – Viktória Nagy, Université Paris Cité
  • - Teaching the teachers – Viktória Nagy, Université Paris Cité
Literature
    required literature
  • Training materials are available on the CONSCIOUS II training platform - http://consciousii.novaims.unl.pt/login/index.php Access provided by PharmDr. Jitka Rychlíčková, Ph.D. Further details on the curriculum: http://conscious2.eu/
Teaching methods
The course is delivered in fully online format – combining pre-class reading, watching the recordings of the international online lessons and completing the tasks on the training platform (quizes, discussion boards, etc.) to develop practical skills key for clinical trials.

Online consultations with content experts will be possible to schedule during the semester as needed. Please contact the course guarantor (dr. Jitka Rychlickova, rychlickova@med.muni.cz) to schedule them.

Training materials are available on the CONSCIOUS II training platform - http://consciousii.novaims.unl.pt/login/index.php Access provided by PharmDr. Jitka Rychlíčková, Ph.D.
Assessment methods
Certificates and credits are issued for studying available core content, completing activities and practical exercises on the training platform. (http://consciousii.novaims.unl.pt/login/index.php).
Language of instruction
English
Further comments (probably available only in Czech)
Study Materials
The course is taught in blocks.
Teacher's information
http://consciousii.novaims.unl.pt/login/index.php
Training materials are available on the CONSCIOUS II training platform - http://consciousii.novaims.unl.pt/login/index.php

Access provided by PharmDr. Jitka Rychlíčková, Ph.D.

For the the details on the course, please contact PharmDr. Jitka Rychlíčková, Ph.D. (rychlickova@med.muni.cz); she is responsible for organizing the lessons and awarding credit.

Office hours of the Secretariat of the Department of Pharmacology, UKB, Kamenice 5, Building A19 daily from 13.00 to 14.00, tel: 54949 3070.

The development of this course was supported by the Erasmus+ Programme of the Europe Union (2021-1-CZ01-KA220-HED-000023177).

The course is also listed under the following terms autumn 2023, autumn 2024.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/med/autumn2025/DSCHCT