Veidlapa Nr. M-3 (8)
Study Course Description
Clinical Trials and Implementation
Course Code
LFK_020
Branch of Science
Basic medicine; Clinical Pharmacy
ECTS
3.00
Target Audience
Clinical Pharmacy; Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Baiba Mauriņa
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, 16 Dzirciema Street, zftk@rsu.lv, +371 67409129
About Study Course
Objective
To promote obtainment of knowledge and formation of understanding about organization of clinical researches, monitoring process, the procedure itself, actors involved in it as well as the importance of research and its significance in creation of new drugs/medicine.
Preliminary Knowledge
Study courses completed in undergraduate pharmacy studies - Pharmaceutical pharmacology, Pharmacotherapy in pharmacist practice, Clinical research, their analysis.
Learning Outcomes
Knowledge
1.After successful fulfillment of the study course, students will posses knowledge which allows to: • freely talk about the phases of clinical research process; • explain the process of clinical research and different actors involved in the process; • evaluate the documentation clinical research according to its design and peculiarities; • understand the importance of clinical research in creation of new medicine and its abilities to enter the market.
Skills
1.On completion of the study course, students will be able to: • evaluate the process of clinical research according to the existing legislation and international standards; • conclude about quality of clinical research according to its design and peculiarities; • create and plan clinical researches.
Competences
1.On completion of the study course, students will be able to: • take part in process of clinical research, by working in Ethics commission and monitoring researches; • organize and take part in obtainment of data, processing, interpretation and publication.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
Individual and pair work – creation of presentations according to the topic.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
Active participation in practical activities, written assignments done in time and according to requirements. The evaluation of the exam consists of the evaluation of the presentation of the independent work.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Introduction to international standarts and local legislation, which regulates the research process in Latvia and in the world
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Data processing and the basic principles of formating of documentation for clinical researches
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Data processing and the basic principles of formating of documentation for clinical researches
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Data processing and the basic principles of formating of documentation for clinical researches
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Qualitity monitoring systems
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
The role of health care specialist in clinical researches
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
The role of health care specialist in clinical researches
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
3
|
Topics
|
Evaluation of the quality of clinical researches and the peculiarities of the design
|
Total ECTS (Creditpoints):
3.00
Contact hours:
24 Academic Hours
Final Examination:
Exam
Bibliography
Required Reading
1.
Ministru kabineta noteikumi Nr.289, Rīgā 2010. gada 23. martā "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" (akceptējams izdevums)
2.
ICH Topic E 6 (R1) Guideline for Good Clinical Practice
3.
FDA guidelines for clinical reasearch
4.
Brody, Tom, Ph.D. 2016. Clinical Trials. 2nd ed. Elsevier. Iegūts no: via Clinical Key
5.
Ārvalstu studentiem/For international students:
6.
ICH Topic E 6 (R1) Guideline for Good Clinical Practice
7.
Brody, Tom, Ph.D. 2016. Clinical Trials. 2nd ed. Elsevier. Iegūts no: via Clinical Key
Additional Reading
1.
Lawrence M. Friedman, Curt D. Furberg, David L. DeMets. “Fundamentals of Clinical Trials”. Springer; 3rd ed. 2015
2.
Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, et.al. “Designing Clinical Research”. Lippincott Williams & Wilkins; 2015
3.
Judy Stone. “Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators”. Mountainside MD Press; Revised edition (August 1, 2010).
Other Information Sources
1.
Ar zāļu klīniskajiem pētījumiem saistītās Eiropas direktīvas (arī latviešu valodā), vadlīnijas, pieteikumu formas, „Jautājumu un atbilžu dokumentu” un citu vērtīgu informāciju varat meklēt: http://eudract.ema.europa.eu > Access to EudraCT Supporting Documentation > EudraLex Volume 10