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Information for promoters of clinical trials

Prior confidentiality agreements and, subsequently, the initial draft of the protocol and feasibility questionnaires, must be sent to the coordinator of each service or alternatively to the lead researcher (LR) responsible for the pathology.
The complete list of the coordinators and researchers, as well as their contact details, can be found in Annex I.

For global centre projects, a visit must be arranged with the general coordinator of the clinical research unit (CRU) (Annex I). For specific projects and trials, visits must be arranged with the coordinator of each service (Annex I). The basic details and features of the centre can be found in Annex II.

The project is evaluated by an internal scientific committee (GRICOBAD) which enables obtaining the approval of the centre. The approval of the centre is an indispensable condition for the clinical research ethics committee (CREC) to evaluate the project. The CREC of reference for the projects of the CRU of the ICO is the Germans Trias i Pujol University Hospital CREC.

The GRICOBAD meets weekly, while the CREC accepts projects from 1st to 5th of each month and holds its plenary meeting on the last Friday of each month.

To obtain the approval of the centre the trial protocol and the financial report must be sent to the secretary of the GRICOBAD before or at the same time it is sent to the CREC.


Secretary of the GRICOBAD Anna Woessner           awoessner@iconcologia.net
Technical Secretary of the CREC Àngels Fortes           avaluacionsceic.germanstrias@gencat.cat
President of the CREC  Dr.Magí Farre          mfarre.germanstrias@gencat.cat


The CREC has specific additional documentation to admit project applications which is available on the Hospital Universitari Germans Trias i Pujol website or the specific CREC site.
Further information on procedures of the CREC http://www.ceicgermanstrias.cat

The drafting and processing of clinical trial contracts is the responsibility of Carolina Soler. To avoid delays in the processing of the contract, it is recommended to start the proceedings as soon as the CREC has approved the project, or even prepare a preliminary draft before CREC approval if no major drawbacks are envisaged.

Person responsible for contract management:

Carolina Soler Soto    csoler@iconcologia.net
The most important aspects for consideration in the drafting and preparation of the contract, together with the financial and administrative aspects, are set out in Annex III.

The start-up visit will be arranged with the coordinator of the service involved and the LR (Annex I).

It is useful to inform the trials nursing coordinator and the pharmacist in charge directly if you wish to ensure that they are at the same start-up visit or can attend the monitor on the same day as the rest of the team.

Trial pharmacy  Marta Munné  assaigsfarmacia_bad@iconcologia.net
Nursing coordinator Olga Fernández    aacc@iconcologia.net

Monitoring visits will be arranged with the coordinator of the service involved and the LR or the technician of the corresponding trial (Annex I), with the nursing coordinator and with the person in charge of the pharmacy (see paragraph five). The CRU financial-administrative manager will be informed of all monitoring in parallel.

Financial-administrative manager:

Carolina Soler    uicico_badalona@iconcologia.net
The closeout visits will be arranged in advance with the financial-administrative manager to perform the financial closeout of the trial.

The invoicing of visits and procedures will be carried out in accordance with the terms set out in the contract. A pro forma invoice will be issued and sent in parallel to the financial-administrative manager of the CRU and to the person responsible for issuing the invoice at the Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, specifying the sponsor, the trial in question and the invoiced item(s):

Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol  Toni de Latorre  atorre@igtp.cat
CRU Manager  Carolina Soler  uicico_badalona@iconcologia.net

Once the pro forma invoice has been accepted, the foundation will issue the invoice to the sponsor, which will be payable under the terms established according to the contract.

Comité ètic de recerca clínica – Clinical Research Ethics Committee
Hospital Universitari Germans Trias i Pujol. Main floor. Maternity building. Ctra. de Canyet, s/n, 08916 Badalona.

Technical Secretary: Àngels Fortes     ceic.germanstrias@gencat.cat

Unitat de Recerca Clínica ICO Hospital Universitari Germans Trias i Pujol – ICO Clinical Research Unit Germans Trias i Pujol University Hospital
Hospital Universitari Germans Trias i Pujol. 6th floor. Maternity building. Ctra. de Canyet, s/n, 08916 Badalona.

Generic e-mail address:     uicico_badalona@iconcologia.net

ICO technical secretariat and relations with the CREC:

A. Woessner     awoessner@iconcologia.net
Contract management and relations with the sponsors:
Carolina Soler       csoler@iconcologia.net

Financial management and relations with the Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol:
Carolina Soler      csoler@iconcologia.net

Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol – Germans Trias i Pujol Health Sciences Research Institute Foundation
Hospital Universitari Germans Trias i Pujol. Main floor. Maternity building. Ctra. de Canyet, s/n, 08916 Badalona.

Treasury and issuance of invoices:
Antoni de la Torre     atorre@igtp.cat

Update:  03.11.2011