DSCHCT Designing and Conducting Human Clinical Trials

Faculty of Medicine
autumn 2023
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 the 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 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.
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
  • The lessons are always on Tuesday from 6 PM – 7,30 PM (CET). The link to online lessons will be sent only to participants registered on the website http://conscious2.eu/; registration will be open from September 2023 to 30 November 2023; link for registration: https://forms.office.com/e/ekHejx3GAk)
  • - January 9, 2024 – course opening – introduction of the course, of the team, opening the platform, giving material to students (all partners)
  • - January 16, 2024 – Clinical Trial Designs – Frances Shiely, University College Cork
  • - January 23, 2024 – Early Phase Trials – Annamária Németh, University of Szeged
  • - January 30, 2024 – Pediatric Clinical Trials – Kateřina Nebeská, Masaryk University
  • - February 6, 2024 – Quality and regulatory affairs and sources of regulatory information – Zora Čechová, Masaryk University
  • - February 13, 2024 – Trial Management – Joana Batuca, Sara Maia, Universidade NOVA de Lisboa
  • - February 20, 2024 – Data management and statistical analysis – Gábor Kovács, University of Pécs
  • - February 27, 2024 – Pharmacovigilance and study medication – Frances Shiely, University College Cork, Lenka Součková, Jitka Rychlíčková, Masaryk University
  • - March 5, 2024 – Trial Methodology – Frances Shiely, University College Cork
  • - March 12, 2024 – Medical Devices – Annamária Németh, University of Szeged
  • - March 19, 2024 – Leadership for PIs – Viktória Nagy, Université Paris Cité
  • - March 26, 2024 – Open research and scientific publishing – Viktória Nagy, Université Paris Cité
  • - April 2, 2024 – 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 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.
Two registrations are required to pass the subject in 2023/2024: registration of the course in IS + registration via this form: https://forms.office.com/e/ekHejx3GAk (otherwise available on the website: http://conscious2.eu/) (link to online lessons will be sent only to participants registered via the link: https://forms.office.com/e/ekHejx3GAk; registration will be open from September 2023 to 30 November 2023)
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
Each participant attending ≥ 60% of the online sessions can get a certificate of completion of this course. Credits will be awarded based on the certificate.
In 2023/2024, certificates are released for attending ≥ 60% of the online sessions.
In subsequent years, certificates are issued for studying available core content, completing activities, practical exercises. (http://consciousii.novaims.unl.pt/login/index.php)
Language of instruction
English
Further comments (probably available only in Czech)
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.

Two registrations are required to pass the subject in 2023/2024: registration of the course in IS + registration via this form: https://forms.office.com/e/ekHejx3GAk (available on the website: http://conscious2.eu/) (link to online lessons will be sent only to participants registered here: https://forms.office.com/e/ekHejx3GAk; registration will be open from September 2023 to 30 November 2023)

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).

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