DSCHCT Designing and Conducting Human Clinical Trials

Faculty of Medicine
autumn 2024
Extent and Intensity
0/0/0. 3 credit(s). Type of Completion: z (credit).
Teacher(s)
PharmDr. Zora Čechová, Ph.D. (seminar tutor)
doc. MUDr. Regina Demlová, Ph.D. (seminar tutor)
Mgr. Kateřina Nebeská (seminar tutor)
PharmDr. Jitka Rychlíčková, Ph.D. (seminar tutor)
PharmDr. Lenka Součková, Ph.D. (seminar tutor)
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.
- Training in networking, multinational cooperation, professional language, expansion of interprofessional cooperation.
- Inspiration on how to organize blended classrooms, international classes online, and how to use materials available.

The course is delivered in a flipped-classroom format – combining pre-class reading, working on the training platform, watching recordings from the international online lessons.
A voluntary F2F course will be conducted on September 11-12, 2024 in Brno, to train communication and collaboration in multinational teams and further develop practical skills key for clinical trials. This course is a voluntary part of this subject, an extra registration is needed (contact the guarantor to register).
Otherwise, online consultations with content experts will be possible to schedule during the semester as needed.
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
  • F2F course in Brno, September 11-12, 2024:
  • September 11, 2024
  • 9,00 - 10,30 Regulatory affairs, quality management (Zora Cechova, Masaryk University)
  • 11,00 - 12,30 Pediatric clinical trials (Katerina Nebeska, Masaryk university)
  • 13,30 - 15,00 Pharmacovigilance and study medication (Lenka Souckova, Jitka Rychlickova, Masaryk University)
  • September 12, 2024
  • 9,00 - 10,30 CONSCIOUS II Multiplier event - clinical trialists of the future
  • 10,45 - 12,15 Trial methodology (Frances Shiely, University College Cork)
  • 12,15 - 13,30 Poster session, networking
  • 13,30 - 15,00 Trial management (Joana Batuca, NOVA University Lisbon)
  • 15,30 - 17,30 Leadership for PIs (Viktoria Nagy, Université Paris Cité, University of Pécs)
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 flipped classroom format – combining pre-class reading and international online lessons (live in 2023/2024, recorded in the next years) to train communication and collaboration in multinational teams and further develop practical skills key for clinical trials.


A voluntary F2F course will be conducted on September 11-12, 2024 in Brno, to train communication and collaboration in multinational teams and further develop practical skills key for clinical trials. This course is a voluntary part of this subject, an extra registration is needed (contact the guarantor to register).
Otherwise, online consultations with content experts will be possible to schedule during the semester as needed.

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) Or for attending all lessons of the F2F course scheduled for September 11 and 12, 2024, in Brno (see the schedule above).
Language of instruction
English
Further comments (probably available only in Czech)
Study Materials
The course is taught: in blocks.
Information on the extent and intensity of the course: 12x2x50 minutes.
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 registration for the F2F course on September 11 and 12, 2024 in Brno, please contact PharmDr. Jitka Rychlíčková, Ph.D.

PharmDr. Jitka Rychlíčková, Ph.D., tel. 54949 6025 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.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/med/autumn2024/DSCHCT