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Presentation

The IDIBGI Clinical Research Unit was created with the aim of optimising and promoting clinical research, both that promoted by the pharmaceutical industry and that carried out at the institution itself.

The objective is to advise the researcher in the planning of projects from both the methodological and regulatory point of view and to support their execution.

On the other hand, it also aims to be a useful and transparent tool for patients so that they can know at all times what research is being carried out in our centres and how to participate in it.

All clinical research carried out by the Clinical Research Unit must also have the approval of the Ethics Committee of Research with Medicines (CEIM) or the ICS/IAS Technical Office for Clinical Research and Clinical Trials:

Who we are

The Clinical Research Unit is currently made up of a Scientific Director, a Unit Manager, clinical trial coordinators, specialised nurses and a date entries. This team is responsible for all activities, from the start-up of a study to its completion, offering quality support to achieve clinical research excellence.

If I am a patient

How can I participate in a research project?

Participation in a research project is generally proposed by the professional who is in contact with the patient.

Sometimes, according to the type of study it is the patient who offers themselves in response to calls for participants through adverts or registries.

Who can participate in a research project?

Several criteria are established in the research projects that describe who can and cannot participate. They are called inclusion criteria and exclusion criteria, respectively.

The basic factors that predetermine participation in a study include: age, gender, type of disease, stage of the disease, previous treatment, other medical conditions.

In the case of clinical trials with these criteria the patients are protected from receiving treatment that may harm them, as not all trials are suitable for all patients. A trial may be safe for one patient, but unsafe for another with the same diagnosis.

Compliance with current legislation and work procedures followed at the hospital ensure appropriate control. as well as the provision of the necessary resources to carry out the research activities, with the highest levels of commitment to quality and ethics.

Information to the patient and informed consent

In accordance with the ethical principles that regulate the research, participants in research studies must be informed of what the study consists of, the procedures that will be performed and the possible risks.

Thus, in general it includes one or more conversations between the patient and the researchers.

Having received all of this information, the patient will be asked to read and sign a document of informed consent stating that they have received this information and that they have resolved any doubts.

If I am a researcher

Objectives of the unit

The unit aims to offer regulatory support (ethical and legal), methodological and scientific support and support in carrying out the clinical research.

How we can help you

  • Collaborate in the initial assessment of the feasibility of the study at the centre (feasibility study).
  • Facilitate communication between the sponsor, the research team and the centre to streamline the initial formalities of the project.
  • Organize visits from the participating subjects and all tests and procedures of the study and attend to the monitors.
  • Help the research teams to reach the number of participants agreed on and in the best recruitment time.

Information to the patient and informed consent

In accordance with the ethical principles that regulate the research, participants in research studies must be informed of what the study consists of, the procedures that will be performed and the possible risks.

Thus, in general it includes one or more conversations between the patient and the researchers.

Having received all of this information, the patient will be asked to read and sign a document of informed consent stating that they have received this information and that they have resolved any doubts.

Clinical trials active at the centre

Please go to the page Clinical Research

Relevant links

Legislation

Llei de garanties i ús racional del MedicamentReial Decret 1090/2015 d'assaigs clínicsOrdre de Ministeri de Sanitat 256/2007 sobre bona pràtica en investigació

Contact

Cristina Martinez
Clinical Research Unit Manager

Hospital Universitari de Girona Dr. Josep Trueta
Av. de França, s/n, Girona, 17007
Pavelló de Govern, 3a planta, despatx 330
E-mail: cmartinez@idibgi.org
Tel: 972.940.200 (Ext. 2343)

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