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Clinical Research Ethics Committee (CEIm)

The Vall d'Hebron University Hospital is an institution that maintains institutional leadership in the health system in the field of clinical trials. The number of clinical trial protocol implementation proposals, most of which are sponsored by the pharmaceutical industry, is one of the highest in Spain.

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Mission

The Vall d'Hebron University Hospital's CEIm aims to decisively contribute to improving the quality, management and relevancy of clinical trials that are to be carried out in our environment. This positioning makes clear the desire to strengthen the positioning of the Hospital and its CEIm, not only in terms of being more competitive in the research market, but also developing and exercising leadership in the promotion of research that aims to solve clinical problems.

Mireia Navarro
Aims

The ethical-methodological evaluation of clinical trial protocols and research projects corresponds to the Hospital's CEIm. The European and Spanish regulations on clinical trials require intense development of the capacities and functions of CEIms, especially with regard to multicentre trials. Similarly, the development of the regulations requires that post-authorisation observational studies be evaluated by the CEIm.

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Actions

The Ethics Committees Support Unit (USCE) aims to improve the quality and efficiency of the actions of the Ethics Committee for Research with Medicines (CEIM) and the Animal Experimentation Committee (CEEA) of the Vall d'Hebron University Hospital, in accordance with current Catalan, Spanish and European legislation.

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Documents a l'arxiu (història).
History

The Clinical Research Ethics Committee (CEIm) at the Vall d'Hebron University Hospital was created on 26 October 1992 (Department of Health and Social Security Order 26.10.1992) to enforce Law 25/1990, dated 20 December, regarding drugs.

This law establishes the need for all clinical trial projects with drugs and medical devices to be previously approved by a clinical research ethics committee, which will have to be accredited by the competent authority, which, in the case of Catalonia , is the Department of Health and Social Security of the Generalitat of Catalonia. 

Acreditacions

Accreditations

Get to know the accreditations of the Vall d’Hebron University Hospital CEIm.

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Notifications

The CEIm monitors clinical trials with drugs and clinical research with medical devices carried out at the centers within its scope of action. Consult which notifications the committee has to receive and how to notify them.

Rates

Download the fees of the Vall d’Hebron University Hospital CEIm.

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Evaluation requirements

Here you will find all the necessary information for the CEIm evaluations.

Do you want to know more about CEIm?

Consult this section to know more about how the Clinical Research Ethics Committee works and to clarify any doubts about its actions.

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Documents

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CEIm calendar

PDF 0.47 MB

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Anual Report 2021 CEIM

PDF 0.28 MB

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Legislation

PDF 0.43 MB

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Internal operating rules

PDF 1.8 MB

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Notification of the Public Prosecutor of clinical research with incapacity to consent and without direct benefit

PDF 0.24 MB

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Notification of the Public Prosecutor of clinical research with persons incapable of consenting due to their clinical situation

PDF 0.24 MB

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Notification of the Public Prosecutor of clinical trials with minors

PDF 0.24 MB

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Ethical bibliography

PDF 0.04 MB

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Links of interest

PDF 0.07 MB

Scope of action

Know the institutional and/or geographic scope of accredited action of the Clinical Research Ethics Committee (CEIm).