Clinical Trials (MDAK_076)
About Study Course
Objective
Deepen student understanding of the clinical research planning, management, documentation and reporting of results according to the international ethical and quality standards. Acquire basic principles of a good clinical practice. Acquire knowledge on the rights and obligations of trail subjects. Facilitate the acquirement of knowledge and skills in the field of clinical research and be able to use the appropriate professional terminology.
Prerequisites
Basic principles of quality assurance, scientific article research and analysis skills.
Learning outcomes
1.As a result of the completion of the study course, students will acquire knowledge and understanding of planning, organising, managing, documenting clinical trials and reporting results in accordance with international standards of ethics, quality and good clinical practice. Students will learn the basic principles of good clinical practice, professional terminology, and understand the rights, responsibilities and responsibilities of the parties and subjects involved in the study. At the end of the course, students will be able to link theoretical knowledge with practical examples, apply clinical trial methods in a reasoned manner and develop a research protocol.
1.During the course, students will learn appropriate professional terminology and develop the ability to use it in the context of clinical trials. Students will be able to link theoretical knowledge to practical examples of clinical trials, reasonably justify the chosen study approach and apply clinical trial methods to the development of the research protocol.
1.After completion of the course, students will be able to analyse the structure of the clinical trial, evaluate the ethical and methodological aspects of the study, describe the principles of documentation and data management of the study, as well as prepare and present the clinical trial protocol in compliance with the requirements of research ethics, data protection, safety and quality.
Study course planning
| Study programme | Study semester | Program level | Study course category | Lecturers | Schedule |
|---|---|---|---|---|---|
| Nursing Studies | 3 | Master's | Required | Agita Melbārde-Kelmere |
