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CEIm Girona (Ethics Committee of Research with Medicines)

Presentation

Ethics Committee of Research with Medicines (CEIm) are bodies that are independent from the sponsors of a research or investigation project.

They are made up of healthcare and non-healthcare members ensure the protection of the rights, safety and welfare of the subjects that participate in clinical trials and other research projects that are evaluated.

Decree 406/2006 regulates the requirements and accreditation procedure for Clinical Research Ethics Committees under the Department of Health,

Girona CEIm presents normalized work procedures in accordance with the regulations for clinical trials with medicines and health products(RD 1090/2015 dated December 4th).

Accreditation
Structure
Areas of action
CEIm annual reports
PNTs

Accreditation

The REC at the Hospital Universitari de Girona Dr. Josep Trueta, was first accredited by the General Directorate of Health Resources in 1993, according to the resolution dated December 16th.

Subsequent accreditations issued on October 19th, 2007; April 26th, 2012.

On November 20th, 2015, CEIC at the Hospital Universitari de Girona Dr. Josep Trueta and the CEIC IAS merged, forming the CEIC Girona.

On February 28th, 2020, the committee was accredited to act as a CREC, in accordance with the regulations established in RD 1090/2016 and goes on to be named CEIm Girona.

Subsequent accreditations issued on September 13th 2024.
Accreditation: February 2020Reaccreditation: September 2024

The CEIm is composed of 19 members: president, vice-president, secretary, and 16 board members.

President

Mercè Fernández Balsells. Medicine, Endocrinology

Vice-President

Marina González del Rio. Nurse

Technical Secretary

Carla Contra Farreró. Biotechnologist

Board Members

  • Carmen Andreu Oller. Biotechnologist
  • Judit Bassols Casadevall. Biologist
  • Anna Bonmatí Tomàs. Pharmacist and nurse
  • Xavier Castells Cervelló. Medicine, Clinical Pharmacology
  • Montse Cols Jiménez. Pharmacist, Primary Care
  • Nadina del Moral Roura. Law. Data Protection Officer
  • Sara Ferrer Suay. Pharmacist
  • Adelaida García Velasco. Medicine, Oncology
  • Ferran Garcia-Bragado Dalmau. Medicine. External member
  • Josep Garre Olmo. Psychology and Epidemiology
  • Anna Liarte Navascues. UAU
  • Blanca Martínez Sánchez. Hospital Pharmacist
  • Pere Plaja Roman. Medicine, Pediatrics
  • Jose Ignacio Rodríguez Hermosa. Medicine, Surgery
  • José Ignacio Sobrino Cortés. Jurist
  • Narcís Vazquez Busquets. Patient representative

President

Mercè Fernández Balsells. Medicine Endocrinology

Vicepresident

Joaquin Serena Leal. Medicine Neurology

Technical Secretary

Marta Riera Juncà. Pharmacist

Members

- Judit Bassols Casadevall. Biologist

- Anna Bonmatí Tomàs. Pharmacist and nurse

- David Cámara Liebana. Nurse

- Anna Carbó Bagué. Medicine. Oncology

- Xavier Castells Cervelló. Medicine. Clinical Pharmacist

- Montserrat Cols Jiménez. Primary Care Pharmacist

- Nadina del Moral Roura. Law. Responsible for data protection

- Daniel García Asquerda. UTIC

- Ferran Garcia-Bragado Dalmau. Medicine. External Member

- Josep Garre Olmo. Psychology and epidemiology

- Marina González del Rio. Nurse

- Maria Rosario González Gómez. Patient representative

- Blanca Martínez Sánchez. Hospital pharmacist

- Erick Mayer Arispe. Medicine. Paediatric

- Antonio Mestre Fusco. Medicine. IDI

- Dúnia Pérez del Campo. Pharmacist. Clinical analyses

- Pere Plaja Román. Medicine. Paediatrics

- Glòria Reig Garcia. Nurse

- Jose Ignacio Rodríguez Hermosa. Medicine. Surgery

- Carme Seculi Motas. UTIC

- José Ignacio Sobrino Cortés. Jurist

- Francesca Terrón Collado. Nursery Assistant. UAU

Hospital health centres

  • Centre Palamós Gent Gran – Fundació Hospital de Palamós – Serveis de Salut Integrats Baix Empordà (H17665527)
  • Centre Sociosanitari Bernat Jaume – Fundació Salut Empordà (H17573386)
  • Centre Sociosanitari Parc Martí i Julià – Salt (H17662156)
  • Clínica Bofill – Girona (H17001460)
  • Clínica Girona – Girona (H17001491)
  • Hospital de Figueres – Fundació Salut Empordà (H17001438)
  • Hospital de Palamós – Fundació Hospital de Palamós – Serveis de Salut Integrats Baix Empordà (H17001580)
  • Hospital Psiquiàtric – IAS – Salt (H17001533)
  • Hospital Santa Caterina – IAS – Salt (H17001526)
  • Hospital Universitari de Girona Dr. Josep Trueta (H17001484)
  • Institut Català d’Oncologia Girona (ICO) (H17609346)

Outpatient health centers

  • Banc de Sang i Teixits – Girona (E1766108)
  • Centre d’Optometria Revip (V17539314)
  • Clínica Bofill, S.L. (E17596922)
  • NEUPSI, centre mèdic – Clínica Bofill (E17630115)
  • Centres d’atenció primària i consultoris mèdics – Fundació Hospital de Palamós – Serveis de Salut Integrats Baix Empordà
  • Centres d’atenció primària i consultoris mèdics locals – Fundació Salut Empordà
  • Centres d’atenció primària i consultoris mèdics locals – Institut d’Assistència Sanitaria (IAS)
  • Centres d’atenció i seguiment de drogodependències – Institut  d’Assistència Sanitaria (IAS)
  • Centres de dia i de salut mental – Institut  d’Assistència Sanitaria (IAS)
  • GIREXX Girona (U17865607)
  • GIREXX Barcelona (E08610581)
  • lnstitut de Diagnòstic per la lmatge - Girona (E17047320)

Institutions or centers not registered in the Registry of Centers, Services and Health Establishments of Catalonia

  • Biobanc de l’Institut d’Investigació Biomèdica de Girona (IDIBGI), Girona
  • Hipra Scientific, S.L.U., Amer
  • Institut d’Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona
  • Spinreact (grup TOYOBO), Sant Esteve d’en Bas
  • Universitat de Girona (UdG)
  • Organisme Autònom de Salut Pública de la Diputació de Girona (DIPSALUT), Girona

CEIm annual reports

An annual report of activities is produced by the Technical Secretariat of the CREC.

According to article 7.9 of Decree 406/2006, the annual report of activities is public and must be available to anyone that requests it.

Activity reports

PNTs

Decree 406/2006 regulates the requirements and the procedure for accreditation of the clinical research ethics committees of the Department of Health, and requires constant updating of the regulations and work plans of the RECs.

In order to comply with RD 1090/2015, the IRBs that wish to evaluate clinical trials with medicines must be accredited as CEIm in accordance with Instruction 1/2017 DGOP and RS: Procedure for accreditation of Clinical Research Ethics Committees (CEIC) as Research Ethics Committees with Medicines (CEIm).

These standard operating procedures of the CEIm are revised in order to incorporate both the current regulations and the current working methodology and to allow the assessment of both clinical trials with medicines and health products, as well as the rest of the study.

Standard work procedures

Evaluation of studies: operation, requirements and documentation

The CEIm meets once a month to evaluate the studies. Depending on the volume, there may be the possibility of a second meeting in the same month.
The deadline for submitting the documentation to be evaluated is set in the calendar of meetings. Documentation submitted after these deadlines remains pending evaluation until the next CEIm meeting.
The complete file must be presented digitally (
ceic.girona.ics@gencat.cat).
Calendar
Circuits
Requirements
Documents/Models
Fees

Calendar

Download the calendar of CEIm 2025 meetings

Circuits

Text under construction.

Requirements

1.  1. Letter of application by the investigator or sponsor for evaluation of the study*.
2. Protocol.
3. Signed commitment of the researcher to the centre and collaborators*.
4. Participation agreement signed by the head of the service*.
5. IP-CEIm commitment*.
6. Data Collection Notebook.
7. Researcher's manual or technical sheet.
8. Photocopy of insurance if applicable.
9. Patient information sheet and informed consent in Spanish and Catalan*.
10. Financial report.
11. Payment of taxes, if applicable. The invoice must be applied for in accordance with the procedure described in section “Taxes”.
12. Conformity of the tutor of the project stating that it is methodologically sound if it is an academic project*.
13. Data Protection Plan and Data Management Form for Research Projects*.

*Documentation that can be found in the section on Models

The documentation must be submitted via e-mail: ceic.girona.ics@gencat.cat.

Informative Document

Documents/Models

• Elaboració de taules i gràfics.

• Redacció mètodes estadístics.

• Interpretació de resultats.

• Protecció de dades.

Request documentation at: ceic.girona.ics@gencat.cat

Fees

CEIm evaluation feesFee request form

Data protection and management in research

In accordance with the new European (Regulation (EU)2016/679) and national (LOPD-GDD 3/2018) regulations, there are many aspects in terms of data protection that must be taken into account when carrying out research.

In order to facilitate the task of preparing projects correctly from this point of view, we provide you with various documents that set out the main criteria:

You can find more information on IDIBGI's data management policy on the page Research Data / Data Protection.

Sex and gender perspective in research content

CEIm Girona underlines the need to incorporate a sex and gender perspective in research. The tool of the Catalan Agency for Health Quality and Assessment (AQuAS) can serve as a guide for its application:

Contracts

IDIBGI manages clinical trial contracts.

This contract can be processed from the moment the request is presented for evaluation at the CEIm.

The delivery of the contract will not take place until receiving the corresponding approval from the CEIm and the conformity of the Centre / suitability of the facilities is received.

For the contract-related procedures, contact contractes.eecc@idibgi.org or visit Administració AACC/EEOO.

Ethical legislation/Standards

CLINICAL TRIALS WITH MEDICINES

Spanish regulations

European regulations

 

OBSERVATIONAL STUDIES WITH MEDICINES

Spanish regulations

  • Real Decreto 957/2020, of 3 November regulating observational studies on medicinal products for human use. 
 
OTHER REGULATIONS
  • Real Decret 1716/2011 del 18 november 2011, published in the BOE on 2 December 2011, which establishes the basic requirements for the authorisation and operation of biobanks for biomedical research purposes and the processing of biological samples of human origin, and regulates the operation and organisation of the National Register of Biobanks for Biomedical Research (from now on, the Royal Decree on Biobanks).
  •  Law on Biomedical Research (14/2007, 3 july).

 

DATA PROTECTION

European regulations

Spanish regulations

  • Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD), published in the Official State Gazette on 6 December 2018.
  • Law 41/2002, of 14 November, basic law regulating patient autonomy and rights and obligations regarding clinical information and documentation.

 

CEIMS ACCREDITATION

Spanish regulations

Catalan regulations

Contacts and locations

Carla Contra - Technical Secretariat
CEIm Girona

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)
Avinguda de França, 30-32-34,
17007 Girona
Tel. 872 987 087 (Ext 302)
Email: ceic.girona.ics@gencat.cat

Doris Olaya - Administrative Secretary
CEIm Girona

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)
Avinguda de França, 30-32-34,
17007 Girona
Tel. 872 987 087 (Ext 301)
Email: ceic.girona.ics@gencat.cat

About IDIBGI!

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