CLINICAL TRIALS

Health research is multidisciplinary and multidimensional and can be classified into basic research, clinical research, and public health research. Within clinical and public health research is where clinical trials with medicines or medical devices and observational studies are framed.

The Clinical Trials Unit of the IRIS-CC is the unit that centralises the aspects of evaluation and contractual, economic and administrative management of clinical trials and observational studies in which the Institute and its affiliated centres participate.

Evaluation, Contractual and Economic Management

Given the strategic, ethical and legal importance, the responsability for the evaluation and management of clinical trials with medicines, medical devices and observational studies falls on the Clinical Trials Unit of the IRIS-CC.

Technical Office

The technical office is the structure of the Clinical Trials Unit of the IRIS-CC, responsible for evaluating the suitability of external sponsor studies with CEIm of reference different from the IRIS-CC field. Thus, all clinical trials with medicines or post-authorisation observational studies will be registered when our CEIm is not the evaluating body.

This office creates the different files (registration and archiving of all documentation) of biomedical research studies carried out within the field of the Institute. Depending on the type of study and promoter, the necessary administrative and contractual procedures are centralised.

This unit is also responsible for controlling the execution of the studies and issuing the invoices of the different observational studies or clinical trials of private or commercial promoter.

Rates

The following documents contemplate both the Clinical Trials Unit and the CEIm:​
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Clinical Trials Unit and CEIm's rates

1 file(s) 173.98 KB
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Rates exemption or reduction form

1 file(s) 51.14 KB
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Responsibility statement of clinical research without commercial profit

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CEIm

The Ethics Committee for Research with Medicines, Health Products and Clinical Interventions (CEIm, from the acronym in Catalan) is an independent body, formed by members with multidisciplinary training. The main purpose of the Committee is to ensure the protection of rights, safety and well-being of the subjects participating in a biomedical research project and that these projects are carried out with guarantees and in compliance with good clinical practices and in accordance with current legislation.

CEIms are accredited in accordance with the terms of Royal Decree 1090/2015, to issue an expert opinion in a clinical study with medicines and clinical research with medical devices. In addition, the functions entrusted to them in their capacity as CEI (Research Ethics Committee, from the acronym in Catalan) must be added.

Researchers willing to launch a clinical research project will need a favourable opinion from the CEIm.

Schedule of Meetings

The CEIm meets, at least, once a month.

Operation

The CEIm evaluates the methodological, ethical and legal aspects of all research projects that are developed within its field of action that involve patients or health professionals, health data or biological samples from patients.

The documentation required by the CEIm is classified according to the type of study, since the legal and regulatory requirements are different.

The requirements and the necessary documentation to process the evaluation of the projects are available in the following two sections:

  • Submission requirements depending on the type of research:
  • Other related documentation:

If you have any doubts in that regard, you can contact the CEIm secretary:
tac.c1722069561c-sir1722069561i@mie1722069561c1722069561

Application for study evaluation

Application form for the evaluation of studies by the IRIS-CC CEIm:

Field of Action

Health centres:

  • CAP ABS Manresa 1 (Althaia Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (E08604066)
  • CAP Bases de Manresa (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (E08605951)
  • CAP Campdevànol (Fundació Privada Hospital de Campdevànol) – Campdevànol (E17006387)
  • CAP del Remei (EAP Vic, S.L.) – Vic (E08031425)
  • CAP La Vall d’en Bas (Fundació Hospital d’Olot i Comarcal de la Garrotxa) – La Vall d’en Bas (E17021233)
  • CAP Ribes de Freser (Fundació Privada Hospital de Campdevànol) – Ribes de Freser (E17046414)
  • Centre de Salut Mental (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (E08692591)
  • Centre de Salut Mental d’Osona (Consorci Hospitalari de Vic) – Vic (E08023992)
  • Centre Hospitalari (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (H08000995)
  • Clínica de Vic, Edificis B i C (Consorci Hospitalari de Vic) – Vic (E08984428)
  • Clínica Sant Josep (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (H08001011)
  • Consultori Bayés-Vic (Consultori Bayés Vic, SL) – Vic (E08028246)
  • Consultoris Bayés Vic-Clínica Vic (Consultori Bayés Vic, SL) – Vic (E08992570)
  • Fundació Hospital Sant Joan de Déu (Fundació Hospital Sant Joan de Déu de Martorell) – Martorell (H08001043)
  • Fundació Universitària del Bages (CU+) (Fundació Universitària del Bages) – Manresa (E08601820)
  • Hospital de Berga (Salut Catalunya Central) – Berga (H08000836)
  • Hospital de Campdevànol (Fundació Privada Hospital de Campdevànol) – Campdevànol (H17001413)
  • Hospital de la Santa Creu Vic (Fundació de l’Hospital Universitari de la Santa Creu de Vic) – Vic (H08001300)
  • Hospital de Sant Andreu (Fundació Privada Sant Andreu Salut) – Manresa (H08000988)
  • Hospital de Sant Jaume de Manlleu (Consorci Hospitalari de Vic) – Manlleu (H08000970)
  • Hospital de Sant Joan de Déu (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa (H08002280)
  • Hospital d’Olot i Comarcal de la Garrotxa (Fundació Hospital d’Olot i Comarcal de la Garrotxa) – Olot (H17001565)
  • Hospital Universitari de Vic (Consorci Hospitalari de Vic) – Vic (H08002135)
  • Institut d’Odontologia i Cirurgia Maxil·lofacial Avançada (IOMA) – Manresa (E08672482)
  • Osonament (Serveis de Salut Mental) – Vic (E08029070)

Non-health centres:

  • Atenció a la pròpia llar (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa
  • Centre Residencial La Llum (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa
  • Fundació d’Estudis Superiors en Ciències de la Salut (FESS) – Vic
  • Fundació Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (Fundació IRIS-CC) – Vic
  • Fundació Privada Elisava Escola Universitària – Barcelona
  • Fundació Universitària Balmes (Universitat de Vic-Universitat Catalunya Central) – Vic
  • Fundació Universitària del Bages (FUBages) – Manresa
  • Residència assistida per a la gent gran “El Nadal” i centre de dia “El Nadal” (Fundació de l’Hospital Universitari de la Santa Creu de Vic) – Vic
  • Residència Aura de Manlleu (Consorci Hospitalari de Vic) – Manlleu
  • Residència i Centre de dia de Castellgalí (Fundació Privada Sant Andreu Salut) – Castellgalí
  • Residència i Centre de dia Mont Blanc (Fundació Privada Sant Andreu Salut) – Manresa
  • Residència i Centre de dia Navarcles (Fundació Privada Sant Andreu Salut) – Navarcles
  • Residència i Centre de dia Sant Andreu (Fundació Privada Sant Andreu Salut) – Manresa
  • Residència i Centre de dia Sant Sadurní (Fundació Privada Sant Andreu Salut) – Callús
  • Servei d’Atenció Domiciliaria Sant Andreu a Casa (Fundació Privada Sant Andreu Salut) – Manresa
  • Servei de llar amb suport temporal o permanent en persones amb problemàtica social derivada de malaltia mental (Althaia, Xarxa Assistencial Universitària de Manresa, F.P.) – Manresa
Composition

The CEIm is composed of a president, a vice-president, a technical secretary and 27 board members. 

Presidency:
Laia Ferré Ybarz. Doctor (Allergology)

Vice-presidency:

Eduardo Kanterewicz Binstock. Doctor (Rheumatology)

Technical Secretary:
Elisabet Roldan Bueno. Psychologist

Board Members:
Carmen Álvarez Sánchez. Doctor (Family medicine)
Gemma Basagaña Colomer. Pharmacist
Maria Bosch Gall. Psychopedagogue
Ester Busquets Alibés. Nurse
Silvia Cano Sánchez. Turism
Xavier Cantero Gómez. Doctor (Family medicine)
Emilia Chirveches Pérez. Nurse
Gemma Cuberas Borrós. Engineer
Gabriel Gerardo Díaz del Gobbo. Doctor (Surgery)
Anna Fàbrega Santamaria. Biologist and Biochemist
Mireia Gallés Muntada. Nurse
Maria Luján Iavecchia. Doctor (Clinical pharmacology)
Ramon Masó Vallmajó. Lawyer
Alicia Minaya Freire. Nurse
Paula Miralles Albors. Pharmacist
Cristina Pérez Reche. Pharmacist
Joel Piqué Buisan. Pharmacist
Gemma Prat Vigué. Psychologist
Emma Puigoriol Juvanteny. Statistician
Basilio Rodríguez Diez. Doctor (Rheumatology)
Pere Roura Poch. Doctor (Epidemiology)
Núria Sensat Borràs. Sociology and Political Sciences
Montserrat Soler Sellarès. Nurse
Júlia Torrent Surrell. Lawyer
Alba Vall Vargas. Nurse
Francesc Sala Cascante. Doctor (Surgery, external member)
Pau Rosique Samper. Pharmacist (External member)

Team

Head of Unit
Gemma Cuberas Borrós
tac.c1722069561c-sir1722069561i@cca1722069561a1722069561

Clinical Trials Manager
Silvia Cano Sánchez
tac.c1722069561c-sir1722069561i@cca1722069561a1722069561
tac.c1722069561c-sir1722069561i@oic1722069561arutc1722069561af1722069561

CEIm Technical Secretary
Elisabet Roldan Bueno
tac.c1722069561c-sir1722069561i@mie1722069561c1722069561