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).
Text under construction.
Documentation part I:
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
8. Scientific advice and Paediatric Research Plan, if applicable.
Documentation part II:
At the local level, in our centers:
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: email@example.com
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: firstname.lastname@example.org.
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
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.
• Elaboració de taules i gràfics.
• Redacció mètodes estadístics.
• Interpretació de resultats.
• Protecció de dades.
Documents are in Catalan.
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.
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.
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
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: 8184.108.40.206 (ext. 12)