DSCHCT Designing and Conducting Human Clinical Trials

Lékařská fakulta
podzim 2023
Rozsah
12x2x50 minutes. 3 kr. Ukončení: z.
Vyučující
PharmDr. Zora Čechová, Ph.D. (cvičící)
doc. MUDr. Regina Demlová, Ph.D. (cvičící)
Mgr. Kateřina Nebeská (cvičící)
PharmDr. Jitka Rychlíčková, Ph.D. (cvičící)
PharmDr. Lenka Součková, Ph.D. (cvičící)
Garance
PharmDr. Jitka Rychlíčková, Ph.D.
Farmakologický ústav – Teoretická pracoviště – Lékařská fakulta
Dodavatelské pracoviště: Farmakologický ústav – Teoretická pracoviště – Lékařská fakulta
Omezení zápisu do předmětu
Předmět je otevřen studentům libovolného oboru.
Cíle předmětu
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.
Výstupy z učení
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.
Osnova
  • 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
Literatura
    povinná literatura
  • 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/
Výukové metody
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 this 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.
Metody hodnocení
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)
Vyučovací jazyk
Angličtina
Informace učitele
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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