Veidlapa Nr. M-3 (8)
Study Course Description
Clinical Trials
Course Code
MDAK_076
Branch of Science
Clinical medicine; Health care sciences and services
ECTS
3.00
Target Audience
Nursing Science
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Agita Melbārde-Kelmere
Structure Unit Manager
Kristaps Circenis
Structural Unit
Department of Nursing and Obstetric Care
Contacts
Riga, 26a Anniņmuižas boulevard, mdak@rsu.lv, +371 67061568
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.
Preliminary Knowledge
Basic principles of quality assurance, scientific article research and analysis skills.
Learning Outcomes
Knowledge
1.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
1.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.
Competences
1.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.
Assessment
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Test lecture 1 |
10.00% from total grade
|
10 points
|
|
2.
Test lecture 2 |
10.00% from total grade
|
10 points
|
|
3.
Test lecture 3 |
10.00% from total grade
|
10 points
|
|
4.
Test lecture 4 |
10.00% from total grade
|
10 points
|
|
5.
Test for informed consent to participate in a clinical trial |
10.00% from total grade
|
10 points
|
|
6.
Test for GCP |
20.00% from total grade
|
10 points
|
|
7.
Test on coordination and monitoring |
10.00% from total grade
|
10 points
|
|
8.
final test |
20.00% from total grade
|
10 points
|
Study Course Theme Plan
FULL-TIME
Part 1
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
Off site
|
Video
|
2
|
Topics
|
Experimental study aims and history.
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
Off site
|
Video
|
2
|
Topics
|
Methodology and design for clinical trials
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
Off site
|
Video
|
2
|
Topics
|
Ethics of Biomedicine and clinical trials
|
-
Video Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
Off site
|
Video
|
2
|
Topics
|
Clinical trial process (coordination and monitoring).
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Experimental study aims and history.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Ethics of Biomedicine and clinical trials
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Patient informed consent process in clinical trials. The rights, duties, safety and well-being of the trial subjects.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Patient informed consent process in clinical trials. The rights, duties, safety and well-being of the trial subjects.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Recognising signs of violence, children's rights, gender equality, LGBTQ+, personal data protection in clinical trials
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Clinical study performance. Clinical study documentation. Good clinical practice.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Clinical trial process (coordination and monitoring).
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Clinical trial process (coordination and monitoring).
|
Total ECTS (Creditpoints):
3.00
Contact hours:
24 Academic Hours
Final Examination:
Exam
Bibliography
Required Reading
1.
Starptautiskās harmonizācijas konferences (ICH/CPMP/135/35) norādījumi par labu klīnisko praksi
2.
ICH E6 (R2) Good clinical practiceSuitable for English stream
3.
Love SB, Yorke-Edwards V, Ward E, Haydock R, Keen K, et al. What is the purpose of clinical trial monitoring? Trials. 2022 Oct 1;23(1):836. PMID: 36183080; PMCID: PMC9526458.Suitable for English stream
Additional Reading
1.
Friedman, L.M., Furberg, C.D., DeMets, D.L. Fundamentals of Clinical Trials. Springer, 2015, p.445Suitable for English stream
2.
Fundamentals of clinical trial designSuitable for English stream
3.
Clinical trials data baseSuitable for English stream
4.
Jones CT, Griffith CA, Fisher CA, Grinke KA, et al. Nurses in clinical trials: perceptions of impact on the research enterprise. J Res Nurs. 2022 Mar;27(1-2):50-65. Epub 2022 Apr 1. PMID: 35392186; PMCID: PMC8980586.Suitable for English stream
5.
Lesley Wilkes, Debra Jackson, Charmaine Miranda, Roger Watson. The role of clinical trial nurses: An Australian perspective, Collegian, Volume 19, Issue 4, 2012, Pages 239-246. https://doi.org/10.1016/j.colegn.2012.02.005.Suitable for English stream
6.
A scoping review of nurse-led randomised controlled trialsSuitable for English stream
7.
Guidance note on the collection and use of data for LGBTIQ equalitySuitable for English stream
8.
Klatte K, Pauli-Magnus C, Love SB, Sydes MR, Benkert P, et al. Monitoring strategies for clinical intervention studies. Cochrane Database Syst Rev. 2021 Dec 8;12(12):MR000051. doi: 10.1002/14651858.MR000051.pub2. PMID: 34878168; PMCID: PMC8653423.Suitable for English stream
9.
Síle F. Molloy, Patricia Henley. Monitoring clinical trials: a practical guide.Suitable for English stream
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.
Zāļu valsts aģentūra
3.
EMASuitable for English stream
4.
Clinical trialsSuitable for English stream
5.
Discussion The research nurse’s role in managing patient expectation in clinical trialsSuitable for English stream
6.
Roles of nurses in clinical trialsSuitable for English stream
7.
Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both WorldsSuitable for English stream
8.
Gender identity, gender-based violence and human rightsSuitable for English stream
9.
Breaking the Cycle of Gender-based ViolenceSuitable for English stream