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Presentation

Clinical Research and Investigational Drugs Ethics Committees (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.

Accreditation: February 2020Last modification of accreditation: April 2021
The CEIm is made up of 23 members: president, vice-president, secretary and 19 members.

President

Mercè Fernández Balsells. Medicine Endocrinology

Vicepresident

Joaquin Serena Leal. Medicine Neurology

Technical Secretary

Marta Riera Juncà. Pharmacist

Members

- Marc Albert Carrasco. Medicine. Digestive

- 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

- M Àngela Cuatrecasas Gomis. Psychologist. Responsible for data protection

- Elisabet Galí Verdaguer. User Attention Unit Nurse

- Ferran Garcia-Bragado Dalmau. Medicine. External Member

- Josep Garre Olmo. Psychology and epidemiology

- Maria Rosario González Gómez. Patient representative

- Blanca Martínez Sánchez. Hospital pharmacist

- Erick Mayer Arispe. Medicine. Paediatric

- Dúnia Pérez del Campo. Pharmacist. Clinical analyses

- Pere Plaja Román. Medicine. Paediatrics

- Glòria Reig Garcia. Nurse

- Jose Ignacio Rodríguez Hermosa. Medicine. Surgery

- Miquel Sitjar Suñer. Nurse

- José Ignacio Sobrino Cortés. Jurist

Hospital health centres

Centre Palamós gent Gran- Fundació hospital de palamós-serveis de salut integrats baix empordà-Palamós (H17665527)
Centre Sociosanitari Bernat Jaume – Fundació Salut Empordà- Figueres (H17573386)
Centre Sociosanitari  Parc Martí i Julià- Salt(H17662156)
Clínica Bofill – Girona
Clínica Girona - Girona (H17001491)
Hospital de Figueres (H17001438)
Hospital  d’Olot i Comarcal de la Garrotxa (H17001565)
Hospital de Palamós (H17001580)
Hospital Psiquiàtric - Salt (H17001533)
Hospital Santa Caterina - Salt (H17001526)
Hospital Universitari de Girona Dr. Josep Trueta (H17001484)
lnstitut Catala d’Oncologia Girona (ICO) (H17609346)

Outpatient health centers

Banc de Sang i Teixits - Girona (E17555108)
Centres d’atenció primària i consultoris mèdics locals gestionats per Fundació hospital de Palamós-Serveis de Salut Integrats Baix Empordà
Centres d’atenció primària i consultoris mèdics locals gestionats per Fundació Salut Empordà
Centres d’atenció primària i consultoris mèdics locals gestionats per Institut  d’Assistència Sanitaria (IAS)
Centres d’atenció i seguiment de drogodependències gestionats per Institut  d’Assistència Sanitaria (IAS)
Centres de dia i de salut mental  gestionats per Institut  d’Assistència Sanitaria (IAS)
Gabinete SME Girona (E17573717)
GIREXX, Ginecologia i Reproducció – Clínica Quirúrgica Onyar – Girona (U17865607)
lnstitut de Diagnostic per la lmatge - Girona (E17047320)
Opticalia Olot – Olot (V17716838)

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

Biobanc de I'lnstitut d'lnvestigació Biomedica de Girona
Hipra Scientific, S.L.U.
lnstitut d'lnvestigació Biomedica de Girona Dr. Josep Trueta (IDIBGI)
lnstitut de Recerca i Tecnologies Agroalimentaries (IRTA) – CTA,CENTA, CAP I EVAM- Monells
SPINREACT  S.A.U
Universitat de 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

Meetings: Operation, Requirements and Documentation

The CEIm meets on the second Tuesday and third Monday of the month, except if it a holiday or significant date.
Documentation must be received, at the latest, ten days before the meeting.
Any documentation presented outside these timelines remains pending evaluation until the next CEIm meeting.
• The complete file must be presented digitally (
ceic.girona.ics@gencat.cat).
Calendar
Requirements
Documents/Models
Taxes

Requirements

2. CEIm CLINICAL TRIAL with medications and / or health products

Documentation part I:

  1. Letter of presentation

In the case of trials with a low level of intervention, comments must be added in the appropriate section.

It is necessary to provide justification and publications that demonstrate compliance with ACBN requirements according to the AEMPS

  1. Request form
  2. Authorization for the requesting party from the sponsor, if applicable
  3. Protocol
  4. Summary of the protocol
  5. Investigator manual or technical sheet of the medication being researched.
  6. Technical sheet or investigator manual for auxiliary medications if applicable

8. Scientific advice and Paediatric Research Plan, if applicable.

 

Documentation part II: 

  1. Selection documents: Recruitment procedures and materials
  2. Information to test patients, informed consent form, and informed consent procedure. It is necessary to provide a version in Spanish and one in Catalan
  3. Suitability of the Investigator: List participating centers, name, position and cv of the PI, Number of planned participants
  4. PI CV
  5. Suitability of the facilities: Signature delegated to CEIm President / Vice President
  6. Insurance or financial guarantee
  7. Financial report
  8. Payment of the CEIm frees when applicable. To request the study evaluation invoice, a form found on the CEIm website must be filled out: www.ceictrueta.cat and it must be sent via email to: ceic.girona.ics@gencat.cat

 

At the local level, in our centers:

  • Signed Commitment of the Principal Investigator at our centre
  • Nominal relationship and signature of collaborators in the study at our centre
  • Participation agreement signed by the head of the service
  • PI-CEIm commitment
  • Commitment from the services involved signed by the person in charge
  • Extra tests from the researcher's own service
  • Patient information sheet and informed consent in Catalan

 

The designated CEIm IS NOT CEIm GIRONA

Performing clinical trials with medications and health products at the HU de Girona Dr. Josep Trueta and/or the IAS in cases where the CREC designated IS NOT CEIm GIRONA, will be subject to review by the Technical Bureau of Clinical trials as stated in the JC/ 7/2016 minutes of the Clinical Board of the HU de Girona Dr. Josep Trueta.

In order to obtain the suitability certificate for the centers, refer to the document "Technical Office for Clinical Research and Clinical trials. Procedures and requirements necessary for carrying out clinical trials with medications and health products at the HU de Girona Dr. Josep Trueta /ICS and  IAS” via mail: recercaclinica@idibgi.org

 

2. NON-CEIm CLINICAL TRIALS with medications and / or health products

1. Sponsor, CRO, and contact person Request.
2. Principal investigator in the centre.
3. Evaluating CEIm.
4. Study protocol and summary.
5. Conformity of the collaborating services involved according to the models found at "Documents/Models".
6. Commitment from the PI and collaborators, PI-CREC Commitment and Head of Service Commitment according to the models found at "Documents/Models".
Extras tests at the researcher's own service.
8. Patient Information Sheet in Spanish and Catalan.
9. Policy.
10. Financial report.
11. Facility suitability.
12. Staff with access to SAP research (models that are located at "documents/MODELS")

La signatura del document de idoneïtat de les instal·lacions de l’Hospital Dr. Josep Trueta i de l’IAS està delegada en el president/vicepresident del CEIm GIRONA.

To obtain the signature of the document of suitability, you must apply by e-mail to recercaclinica@idibgi.org providing the documentation.

If any document is missing, it can still be processed but it will be pending to be received in order to be able to sign the contract.

Informative Document

3. Observational Studies, other studies.

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

4. Projects with Biological Samples

  1. Application by the investigator or sponsor for evaluation of the study*.
  2. Protocol or scientific memory that includes:
    • Description of the methodology: Design, objectives, participant selection criteria, variables of results, genetic analysis and/or data analysis.
    • Indicate the source of obtaining biological samples:
      • Prospectively requesting consent, for obtaining, using and storing if applicable.
      • Stored samples (collection or Biobanc):
      • Location where the project will be carried out, indicating where the determinations of the samples will be performed.
      • Where, when and how the samples will be stored
  3. Data collection notebook.
  4. Signed commitment of the investigator and collaborators in our centre*.
  5. Participation agreement signed by the head of the service*.
  6. IP-CEIm commitment*.
  7. Patient information sheet and informed consent in Spanish and Catalan*.
  8. Financial report if applicable
  9. Policy if applicable
  10. Conformity of the tutor of the project stating that it is methodologically sound if it is an academic project*.
  11. 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

5. Clarifications

Document containing the requirement and the answer and must be signed.

If the answer implies a modification in a document, it must be presented again with the marked change (red, yellow or as it is believed appropriate) and put listed as a new version (example v1.0: 01/01/2020 would change to v2.0: 15/03/20)

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

Informative Document

6. Amendments

1. Letter of request for evaluation of the relevant amendment.

2. Document annex of relevant amendment request

3. If the amendment involves a modification in any document, the document must be resubmitted with the marked change (red, green or however you think it is convenient) and a new version must be added (e.g. v1.0:01/09/19 would change to v2.0:01/03/21).

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

Informative Document

7. Requisits en matèria de protecció de dades

1. Data protection plan

For the preparation of the data protection plan you will find support documentation in the section on data management in research on this page

Data protection plan

2. Data protection form

Forms that can be found in the Documents/MODELS section. 

 

The processing of anonymous data does not require a basis for legitimisation as the data protection regulations do not apply.

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 aacc@idibgi.org or visit Administració AACC.

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

CEIm Girona - ICS-IAS Girona / IDIBGI

Hospital Universitari de Girona Dr. Josep Trueta
Av. de França, s/n
Pavelló de Govern - 3a pl,despatx 327
Tel. 972 94 13 23 (Ext 1323)
Fax 972 48 54 22
Email: ceic.girona.ics@gencat.cat

Comptabilitat i gestió dels contractes

Institut Investigació Biomèdica de Girona Dr. Josep Trueta
C/ Dr. Castany s/n, 17190, Salt
Parc Hospitalari Marti i Julià - Edifici M2
Tel: 872.98.70.87 (ext. 12)
Email: aacc@idibgi.org

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