.
Clinical Trials
Study Course Description
Course Description Statuss:Approved
Course Description Version:7.00
Study Course Accepted:19.01.2024 15:26:17
| 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, mdak rsu[pnkts]lv, +371 67061568 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 5 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 10 | ||||
| Classes (count) | 7 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 14 | ||||
| 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. Clinical study groups. | Lectures | 1.00 | E-Studies platform | |||||
| 2 | Phase of clinical trials. | Lectures | 1.00 | auditorium | |||||
| 3 | Ethics of clinical trial. | Lectures | 1.00 | E-Studies platform | |||||
| 4 | Patient informed consent process in clinical trials. The rights, duties, safety and well-being of the trial subjects. | Lectures | 1.00 | E-Studies platform | |||||
| Classes | 2.00 | auditorium | |||||||
| 5 | Regulations governing clinical trials. Guideline for good clinical practice (GCP), main principles and the most important terms. | Classes | 1.00 | auditorium | |||||
| 6 | Clinical studies coordination and monitoring. | Lectures | 1.00 | E-Studies platform | |||||
| Classes | 1.00 | auditorium | |||||||
| 7 | Parties involved in clinical trials competencies. | Classes | 1.00 | auditorium | |||||
| 8 | Clinical study performance. Clinical study documentation. Clinical trials quality management principles. | Classes | 1.00 | auditorium | |||||
| 9 | Work with the pharmaceutical industry, from the point of health-care views. | Classes | 1.00 | auditorium | |||||
| 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: | Individual presentation of a summary/presentation on the chosen or proposed topic during the class (20 points). Active participation in the discussion and analysis of other students' independent work during class (10 points). Completion of self-assessment tests and practical exercises (70 points). Total number of points:10. | ||||||||
| 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 | Ārvalstu studentiem/For international students: | ||||||||
| 4 | ICH E6 (R2) Good clinical practice | ||||||||
| Additional Reading | |||||||||
| 1 | Baltiņš, M. (2003). Lietišķā epidemioloģijā. Zinātne, p.354 | ||||||||
| 2 | Friedman, L.M., Furberg, C.D., DeMets, D.L. (2015). Fundamentals of Clinical Trials. Springer, p.445 | ||||||||
| 3 | Fundamentals of clinical trial design | ||||||||
| 4 | Clinical trials data base | ||||||||
| 5 | Ārvalstu studentiem/For international students: | ||||||||
| 6 | Friedman, L.M., Furberg, C.D., DeMets, D.L. (2015). Fundamentals of Clinical Trials. Springer, p.445 | ||||||||
| 7 | 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/ | ||||||||
