Clinical Trials

Study Course Description

Course Description Statuss:Approved

Course Description Version:8.00

Study Course Accepted:09.05.2024 14:53:20

Study Course Information
Course Code:		MDAK_076		LQF level:		Level 7
Credit Points:		2.00		ECTS:		3.00
Branch of Science:		Clinical Medicine; Health Care		Target Audience:		Nursing Science
Study Course Supervisor
Course Supervisor:		Agita Melbārde-Kelmere
Study Course Implementer
Structural Unit:		Department of Nursing and Obstetric Care
The Head of Structural Unit:
Contacts:		Riga, 26a Anniņmuižas boulevard, mdakrsu[pnkts]lv, +371 67061568
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		4	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		8
Classes (count)		8	Class Length (academic hours)		2	Total Contact Hours of Classes		16
Total Contact Hours								24
Study course description
Preliminary Knowledge:
Basic principles of quality assurance, scientific article research and analysis skills.
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.
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Experimental study aims and history.			Lectures		1.00	E-Studies platform
				Classes		1.00	E-Studies platform
2	Methodology and design for clinical trials			Lectures		1.00	auditorium
				Classes		1.00	E-Studies platform
3	Ethics of Biomedicine and clinical trials			Lectures		1.00	E-Studies platform
				Classes		1.00	E-Studies platform
4	Patient informed consent process in clinical trials. The rights, duties, safety and well-being of the trial subjects.			Classes		2.00	auditorium
5	Clinical study performance. Clinical study documentation. Good clinical practice.			Classes		1.00	E-Studies platform
6	Clinical trial process (coordination and monitoring).			Lectures		1.00	E-Studies platform
				Classes		1.00	auditorium
7	Recognising signs of violence, children's rights, gender equality, LGBTQ+, personal data protection in clinical trials			Classes		1.00	E-Studies platform
Assessment
Unaided Work:
Students independently search, read and analyse research articles on topical themes in the field of clinical trials. Independently acquaint themselves with the guidelines for good clinical practice and other regulations, governing planning of clinical trials, management and reporting of results. During the course students prepare summaries and presentations on the selected topics on the chosen or offered theme in the filed of clinical research, individually present it in one of the classes, and actively participate in discussing of other students' independent work and analysis.Students complete self-assessment tests on topics covered in classes and lectures. Summative assessment. In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
Assessment Criteria:
Completion of self-tests and practical assignments (40 points - self-tests after video lectures; 60 points - practical assignments in class, including self-tests, diagrams). Mark - total number of points:10. Participation in practical sessions-For each missed session - prepare 10 self-test questions on the topic of the missed session.
Final Examination (Full-Time):		Exam
Final Examination (Part-Time):
Learning Outcomes
Knowledge:		As a result of the study course students will gain knowledge and understanding of the clinical trial planning, management, documentation and reporting of results according to the international ethical and quality standards. Acquire the basic principles of good clinical practice. Know the right and obligations of the parties, including trial subjects, rights and obligations. Learn the appropriate professional terminology.
Skills:		As a result of the study course students will be able to tell about the planning of clinical trials, their design, principles of assurance control, the involved parties and their responsibilities. During the classes will acquire the skill to apply the knowledge gained in the field of clinical trials. Will be able to find and use normative acts, which regulate clinical trials. Will be able to communicate with research subjects on their rights and responsibilities. Will use the professional terminology of clinical trials.
Competencies:		As a result of the study course students will develop competence – ability to successfully take part and participate in clinical trials and provide appropriate care of the trial subjects.
Bibliography
No.	Reference
Required Reading
1	Starptautiskās harmonizācijas konferences (ICH/CPMP/135/35) norādījumi par labu klīnisko praksi
2	ICH E6 (R2) Good clinical practice
3	ICH E6 (R2) Good clinical practice
Additional Reading
1	Friedman, L.M., Furberg, C.D., DeMets, D.L. (2015). Fundamentals of Clinical Trials. Springer, p.445
2	Fundamentals of clinical trial design
3	Clinical trials data base
4	Friedman, L.M., Furberg, C.D., DeMets, D.L. (2015). Fundamentals of Clinical Trials. Springer, p.445
5	Fundamentals of clinical trial design
Other Information Sources
1	Ministru kabineta noteikumi Nr.289 Rīgā 2010.gada 23.martā (prot. Nr.15 34.§) Noteikumi par zāļu klīniskās izpētes un lietošanas novērojumu veikšanas kārtību, pētāmo zāļu marķēšanu un kārtību, kādā tiek vērtēta zāļu klīniskās izpētes atbilstība labas klīniskās prakses prasībām.
2	https://www.zva.gov.lv/ (Zāļu valsts aģentūra)
3	http://www.ema.europa.eu/ema/
4	http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_t…
5	https://clinicaltrials.gov/
6	Ārvalstu studentiem/For international students:
7	http://www.ema.europa.eu/ema/
8	http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_t…
9	https://clinicaltrials.gov/