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

2. Request form
3. Authorization for the requesting party from the sponsor, if applicable
4. Protocol
5. Summary of the protocol
6. Investigator manual or technical sheet of the medication being researched.
7. 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

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):
       • It is necessary to provide the consent model that was signed in the case of private collections and inform about the registration in the registro del Instituto de Salud Carlos III (ISCIII).
       • You must provide the request for samples to the 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

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

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.