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Technical Office for Clinical Research and Clinical Trials - ICS/IAS

Since the coming into force of RD 1090/2015, the management of the documentation of the clinical trials in which CEIM Girona does not act as CREC is performed from the Clinical Research and Clinical Trials Technical Office.

This office is responsible for ensuring that the local aspects for carrying out the trial are resolved and issues the suitability of the centre, as well as favourable reports sent to the medical management for the signing of the contract.

Reference CEIm: CEIm Girona

Request to act as a CEim: Apply to the CEIm Technical Secretariat by email to request availability to act as a CEIm (ceic.girona.ics@gencat.cat)

Please visit the CEIm website, meetings section: operation, requirements and documentation/ requirements / 1.0 CEIm CLINICAL Trials with Medications and/or Health Products

LINK TO ceim

Reference CEIm: other CEIm

Authorization of the centre: suitability of the installations
Gestió documentació addicional

Authorization of the centre: suitability of the installations

The signature of the document of suitability of the facilities of the Hospital Dr. Josep Trueta and the IAS is delegated to the technical secretary of the Technical Office of Clinical Research and Clinical Trials, coordinated with the Ethics Committee of Research with Medicines CEIm GIRONA.

To obtain the signature of the suitability document, it must be requested by email to 
recercaclinica@idibgi.org providing the following documentation:

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 here*

It must ALWAYS be indicated where all of the tests and analyses related to the trial are carried out, accompanied by a statement signed by the head of the service. If the usual hospital services are not use or if external services are used, a letter signed by the sponsor indicating where they are to be carried out must be provided.

6. Commitment from the PI and collaborators, PI-CREC Commitment and Head of Service Commitment according to the models found here.

7. Patient Information Sheet in Spanish and Catalan

8. Policy

9. Financial report

Should any document be lacking, the suitability can be requested however the contract will not be released under any circumstances until all documentation is received.

Document informatiu

Management of additional documentation

In order to stay abreast of the development of the study in the centre, the sponsor commits TO NOTIFYING the following via e-mail to the clinical research and clinical trial technical office (recercaclinica@idibgi.org):

  1. The favourable opinion of the CREC and the authorization from the AEMPS. The corresponding documents will be sent, as well as the final approved protocol, should it not be the same as the one sent in initially.
  2. Any relevant amendment generated during the course of the trial. Should the amendment generate a new patient information sheet, the sponsor must provide a true and reliable translation in Spanish and Catalan.
  3. Notification of the start and end of recruitment and of the end of trial.
  4. Annual follow-up report.
  5. Deviations from the protocol at the centre.
  6. Changes to the contact data of the sponsor, the requesting party or legal representative, and any changes to the requesting party if applicable.

Administration office

Contracts
Contract management

Contracts

The model used is a specific model that can be found at Gestió administrativa d’AACC/EEOO and either one will be used according to the hospital where there study is to be carried out and depending on whether it is a clinical trial or other design.

Contract management

The management and processing of the contract/amendment of the clinical trial or observational study at the centre includes unique and non-refundable administration costs. You can consult the fees at Gestió administrativa d’AACC/EEOO in the FEES section.

Contacts

Marta Riera
Secretaria Tècnica

Oficina Tècnica de Recerca Clínica i Assaigs Clínics
Mail: recercaclinica@idibgi.org
Tel: 972 941 323

Secretaria Tècnica CEIm.
ceic.girona.ics@gencat.cat
Doris Olaya
Secretaria administrativa

Mail: ceic.girona.ics@gencat.cat 
Tel: 972 940 200 ext 2581

Ekram el Fachtali
Contractes

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
C/ Dr. Castany s/n, 17190, Salt
Parc Hospitalari Martí i Julià - Edifici M2
E-mail: aacc@idibgi.org
Tel: 872.98.70.87

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