Formation

The main objective of the course is to provide basic training for clinical researchers in the methodology of the different types of research, applying the standards of Good Clinical Practices.


INTENSIVE COURSE ON ETHICS AND GOOD CLINICAL PRACTICES GEARED TOWARDS INITIATING RESEARCH PROJECTS

On-line mode


The advent of clinical research at healthcare institutions is an increasingly more common activity and it enables professionals to innovate and keep abreast of the latest advances in both medicine and biomedicine. Nonetheless, the healthcare professional who is also a researcher needs to have specific training that goes beyond any self-learning he or she may have undertaken. Rigour needs to be ensured, as do the requirements of the research task at hand from an ethical, legal and technical perspective as the quest for scientific excellence is at stake.

Aimed at clinical researchers, the main objective is to offer basic and essential training in various research methodologies, with particular emphasis placed on Regulations and Standards for Good Clinical Practices. It is envisaged that the course participants shall gain an understanding of the dynamics of pursuing a research project; students will gain an understanding of differences in research approaches, the differences between a trial protocol and other types of studies. If necessary, these areas may be undertaken in the course. Students will do a follow up of the trial or study and prepare the final report. All activities will be carried out in accordance with the Regulations and Standards for Good Clinical Practices which make up the conceptual core of the training pedagogy; these are based on ethical principles and guidelines that have been internationally agreed upon.

In this spirit, the course which has recognised on-going educational credits will enable researchers to meet their training needs in Good Clinical Practices, offering them the requisites that are currently demanded by research promoters and financers in both national and international project proposals. The experience and knowledge acquired in this course will not only enhance an improved approach to clinical trials, it will undoubtedly improve the quality of healthcare delivery and assist in the design of new research projects.


The training programme is aimed at catering to the needs of different kinds of healthcare delivery professionals, namely doctors, however researchers that are also biologists, pharmacists, nursing staff or physiotherapists may find it most beneficial; it is geared towards professionals working in the clinical research setting and aspiring to improve their training.

This activity is also especially suitable for Members of Ethics Committees in Clinical Research and to researchers who have benefitted from grants from any of the official research promotion programmes.

The programme for this activity comprises 7 topics which emphasize the following:

1. An introduction to the ethical foundations that ought to govern biomedical research.

2. Regulations and Standards for Good Clinical Practice.

3. The ethical and legal regulation of clinical research.

4. Protocol considerations.

5. The Investigational New Drug.

6. The development and monitoring of the clinical trial.

7. The winding up and conclusion of the clinical trial.

Detailed information on the programmes can be obtained via the link on the side-column “More information” on this web page.

Course coordinator and tutor:

•Dr. Pau Ferrer Salvans: Specialist in Clinical Pharmacology, with over 20 years’ experience as a Clinical Research Ethics Commission Member at Hospital Universitario de Bellvitge. He currently collaborates with Institut Borja de Bioètica and is also Secretary of the Clinical Research Ethics Commission at Hospital Sant Joan de Déu in Esplugues de Llobregat.

The course lecturers include:

•Dra. Joana Claverol: Co-ordinator of the Clinical Research Unit, Fundación Sant Joan de Déu.

•Dr. Joan Lluís Vinent Genestar: Associate Pharmacist; Specialist in Hospital Pharmacy. Hospital Sant Joan de Déu.

  • Compulsory video sessions – each student shall be required to view 8 hours of audio-visual material, corresponding to the 7 units or topics. This activity can be verified by way of the connection data to the campus housing the platform and accounts for 40% of the final grade.
  • The downloading of complementary materials– each student is required to download at least 30% of the complementary materials offered in each subject; the selection of the said material will be left to the student’s own discretion, in line with their specific interests. Completing this requirement accounts for 10% of the final grade.
  • Exam or final test – given that this is an accredited course with 3,2credits corresponding to on-going education, it is necessary to conduct an exam or final test in order to comply with the student assessment requirement. Each student shall take a multiple-choice test with 30 questions. The result shall make up 50% of the final grade.

The sum total of the aforesaid percentages shall be the final grade of the Course and shall be included on the certificate of accreditation issued to each student.

The INTENSIVE COURSE ON ETHICS AND GOOD CLINICAL PRACTICES GEARED TOWARDS INITIATING RESEARCH PROJECTS is recognised by the on-going healthcare education authority known as Consell Català de Formació Continuada de les Professions Sanitàries – subject to the evaluation commission known as Comisión de Formación Continuada del Sistema Nacional de Salud which has given it an official credit loading of 3,2 credits.


A certificate/diploma of accreditation will be issued to the participants.

REGISTRATION

The fee for the course is 150 €.

To settle the payment, there are three options: 1. A cheque made out to Institut Borja de Bioètica; or 2. payment/transfer into our account, or 3. A credit card payment (using Caixa Catalunya’s TPV). Information in this respect is on the course registration form.

PERIOD OF COURSE AVAILABILITY

The course has an open-type design which is permanently available to researchers, allowing them to do their follow up, without there being the requirement to stick to specific commencement dates. Participants will be able to make a start according to their own commitment and time projections. Each registered participant will have a maximum of 3 weeks, counting from the chosen starting date of the course, to carry out and conclude the course.

CONTACT

Secretary. Institut Borja de Bioètica:

Tel.: 93.600.61.06 - Fax: 93.600.61.10

E-mail

Web

You can forward the registration form by using the link on the web page of Institut Borja de Bioètica:

REGISTRATION FORM


More information


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