GCP - Good Clinical Practice (R2)
Credits
0.5 ECTS (10 hours)
Form of study
Partially web-based
Location
Tartu
Fee
115 EUR
Teachers
Riina Janno
Katrin Kaarna
Katrin Kaarna
Study group
Medicine
Program language
Estonian
Outcome:
The course focuses on principles of clinical trials and Estonian and European Union legislation concerning the conduct of clinical trials. An overview of the phases of clinical trials is provided. The requirements are introduced for physicians, research staff to conduct clinical trials and the documentation required to obtain permission from State Agency of Medicines and the Independent Ethics Committee to conduct a trial, also the documentation what is completed during the trial. The essence of informed consent and the process of obtaining informed consent from the patient or his/her legal representatives is trained. Systems for quality control and assurance of data collected in clinical trials are introduced.
Teachers:
Riina Janno - Katrin Kaarna -
Content:
| Topic | Credit | Lectors |
|---|---|---|
| 1. Independent work with the Good Clinical Trial Practice guidelines Principles of Good Clinical Trial Practice (GCP R2) and phases of clinical trials. Katrin Kaarna Trends of clinical trials in the world and in Estonia. Katrin Kaarna The role of the State Agency of Medicines and Independent Ethics Committee in a clinical trial. Research legislation and regulations. Ravimiamet The informed consent process in a research center. Riina Janno Requirements for the research center. Study documentation and informed consent. dr Reet Kinks Monitoring of clinical trials. Riina Janno Quality assurance of clinical trials. dr Reet Kinks The study drug, drug handling in a clinical trial. The role of the pharmacy in a clinical trial. Riina Janno The process of conducting the clinical trials. Katrin Kaarna |
10 | Riina Janno, Katrin Kaarna |
Location info:
Tartu linn
Learning environment:
Studies and teaching takes place in appropriate classrooms, which have the required teaching equipment and meet the health and safety requirements.
Schedule and further information:
Kõikidel kursustel osalejatel on vaja enne kursust iseseisvalt omandada alusteadmised Heade Kliiniliste Tavade R2 juhtnööridest.
Outcome method:
non-differentiated (pass, fail, not present)
Document to be issued:
Certificate of completion/Certificate of attendance
Tax refund:
Yes
Additional information:
Marika Rosenthal, marika.rosenthal@ut.ee, +372 +372 731 8109
Program code:
MVCM.TK.260
General contact:
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