Coordination: | GOMEZ ARBONES, XAVIER |
Academic year 2016-17 |
Subject name | CLINICAL TRIALS: DESIGN AND MANAGEMENT | ||||||||
Code | 14702 | ||||||||
Semester | 1st Q(SEMESTER) CONTINUED EVALUATION | ||||||||
Typology |
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ECTS credits | 4 | ||||||||
Groups | 1GG | ||||||||
Theoretical credits | 2.4 | ||||||||
Practical credits | 1.6 | ||||||||
Coordination | GOMEZ ARBONES, XAVIER | ||||||||
Department | CIENCIES MEDIQUES BASIQUES,MEDICINA,MEDICINA EXPERIMENTAL | ||||||||
Teaching load distribution between lectures and independent student work | Each credit is calculated as 25 hours of work: 10 hours of lectures and 15 hours of independent study by the students. | ||||||||
Important information on data processing | Consult this link for more information. | ||||||||
Language | Catalan (70%), Spanish (10%) and English (20%; documentation) | ||||||||
Distribution of credits | Total: 4 ECTS
- Lectures: 1.2 ECTS - Practices: 1.6 ECTS - Seminars: 1.2 ECTS | ||||||||
Office and hour of attention | Telèfon: 973702208
Correu: xga@medicina.udl.cat Ubicació del Despatx: 1.04. Unitat Docent Facultat de Medicina. Hospital Universitari Arnau de Vilanova |
Teaching staff | E-mail addresses | Credits taught by teacher | Office and hour of attention |
GOMEZ ARBONES, XAVIER | xga@medicina.udl.cat | 2,6 | |
SANCHEZ DE LA TORRE, MANUEL | sanchezdelatorre@cmb.udl.cat | ,4 | |
SCHOENENBERGER ARNAIZ, JUAN ANTONIO | shoenenberger@mex.udl.cat | 1 |
Guest lecturers: Susana Peñuelas , Laura Rumi, Maria Ruiz, Montse Solanillas, Francesc Verges and Amalia Zapata.
Students who approve this matter will:
Know the fundamental principles of bioethics and clinical research.
Know the rules on human research, especially related to clinical trials.
Be able to propose, design, analyze, monitor and evaluate clinical research studies.
Students will visit the Biobank of IRBLL
Students must attend and participate in a meeting of the Ethics Committee of HUAV Lleida.
Students must sign a commitment to respect the confidentiality of the information that will have access in accordance with "Llei 15/1999, de protecció de dades de caràcter personal", and "Decret 406/2006, de 24 d’octubre, d’acreditació de comitès ètics d’investigació clínica".
The objectives of the course are:
Learn the basic principles of bioethics and clinical research.
Know the legal regulations related to biomedical research.
Know the different types of research studies.
Be able to design and manage a clinical trial protocol and other projects.
Be able to evaluate clinical trial protocols (methodology, ethical and legal issues, informed consent, confidentiality)
Know the procedures for monitoring clinical trials.
Attend a meetings of the Ethics Committee of the Hospital Arnau de Vilanova of Lleida
Participate in clinical research projects of the Biomedical Research Institute of Lleida
Specific skills:
Be able to design, monitor and evaluate protocols for clinical trials.
Other specific skills:
Understand the fundamental principles of bioethics and clinical research
Kown the main legislation on human research, especially related to clinical trials
Be able to design, execute and analyse research studies and protocols (especially clinical trials).
Qualification for the evaluation of clinical trials.
Be prepared to do monitoring and coordination of clinical trials.
In short, be able to propose, design, analyze, monitor and evaluate clinical research studies.
Contents (classroom sessions)
Introduction to different types of projects. Clinical trials.
Clinical and EBM. Role of research and clinical trials
Introduction to methodological and ethical aspects of clinical trials
Clinical trials. Results and importance in decision-making in health.
Regulations and legal issues in clinical trials.
CEIC. .
Methodological and statistical aspects of clinical trials
Units and structures for supporting research and clinical trials
Clinical trials and research projects. Perspective of the researcher I
Clinical trials and research projects. Perspective of the researcher II
Clinical trials and research projects. Perspective of industry
Product management research in the context of clinical trials (1h class). Monitoring research (1h class)
Assays based on records.
Evaluation proojects I
Evaluation projects II
Biobank (storage and custody of samples) (1h class). Informed consent (1h class)
Quality Assurance
Final session.
Other sessions
Practice at the Biobank
Evaluation of projects for CEIC.
CEIC guest assistance (in small groups).
The methodology of the course is based on the following activities:
Master classes about the program contents
Seminars and group work.
Attendance at scientific conferences of guest lecturers
Individual and group work (resolution of problems and activities)
Work on a clinical trial protocol.
Evaluation of clinical trial protocols
Attendance at meetings of the CEIC
Visit a biobank
Participation in research projects
Tutoring by teachers
Oral presentations
Cronogram
0/11/2016. 10-12. Presentation. Introduction to the different types of research projects. Clinical trials.
10/13/2016. 10-12. Introduction to ethical and methodological aspects of clinical trials
18/10/2016. 10-12. EBM and clinical research. Role of research and clinical trials
10/24/2016. 16-18. 1 hour. Regulatory and legal issues in clinical trials. 1 hour. The CEIC.
10/25/2016. 10-12. Clinical trials. Results and significance in decision-making in health.
03/11/2016. 10-12. Clinical trials and research projects. View of the industry
11/08/2016. 10-12. Units and structures supporting research and clinical trials
10/11/2016. 10-12. Methodological and statistical aspects of clinical trials
11/15/2016. 10-12. Project evaluation I
11/22/2016. 10-12. Clinical trials and research projects. Researcher's point of view I
11/29/2016. 16-18. Management of research products under clinical trials (1h class). Monitoring research (1h class)
12/01/2016. 10-12. Assays based on records.
12/13/2016. 10-12. Clinical trials and research projects. Researcher's point of view II
12/15/2016. 10-12. Project evaluation II
12/20/2016. 10-12. Session
01/10/2017. 10-12. Quality assurance
12/01/2017. 10-12. 1 hour. Biobank (storage and custody of samples) 1 h. Informed consent
01/17/2017. 10-12. Session
01/19/2017, 01/24/2017 and 27/01/2017 *
To determine in 2017
2h. Morning. Practice in the Biobank (groups)
2h. Morning. Evaluatins of CEIC projects.
2h. Last Thursday afternoon of each month. CEIC guest assistance (in groups).
* The houes of these sessions are devoted to go to CEIC, evaluate some of the projects and go to the biobank (2017)
The evaluations is based on:
Continuous assessment of attendance and class participation (lectures, seminars and group work).
Practical work and resolution of activities.
Exam (of all learning activities).
The first day we will deal about the conditions of the student evaluation.
Basic::
Web resources: