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How to Submit the Documentation to the CEIM

How to Submit the Documentation to the CEIM

Which projects should be submitted to the CEI?

It is necessary that the following types of projects be evaluated by a Research Ethics Committee (REC):

  • Intervention, diagnostic, or therapeutic studies, different from routine clinical practice
  • Projects that require obtaining informed consent (IC) from participants
  • Observational projects that request or collect clinical data
  • Studies conducted with data from SIDIAP

In general, indexed journals request the opinion of a REC for the publication of any project (observational studies and clinical trials).

Who can submit an application to the CEIm?

Any person working in a center under the supervision of the CEIm of IDIAPJGol may submit the application (see section Centers supervised by the CEIm – list of centers).

If the person works in an ICS center, they must contact the Research Support Unit (USR) of their territory. The USR will be responsible for processing the application. You can find more information about the USRs at: https://idiapjgol.org/unitats-de-suport-territorial-usr/

In the case of SIDIAP projects, prior approval from the SIDIAP Scientific Committee is required before starting the evaluation by the CEIm. You have all the information at: https://www.sidiap.org/index.php/ca/solicituds

In the event that the study has been previously approved by another CEIm, the approval document must be attached

How to do it?

Deadline: Studies may be submitted until the 10th of the current month in order to be evaluated at the meeting held at the end of the month. The deadline closes on the 10th, and from the 11th onward, studies will be included in the following month’s meeting.

The regular meetings of the CEIm are usually held on the last Wednesday of the month.

All required documentation must be submitted according to the type of study (see the documentation section).

The documentation must be sent by email to cei@idiapjgol.org

Language: The documentation may be submitted in Catalan, Spanish, or English. Except for the FIP-CI, which must be presented in Catalan or Spanish.

The Principal Investigator (PI) will be the point of contact with the CEIm, and is the person who will receive communications from the CEI and respond to any clarifications requested.

It is essential that before sending the documentation to the CEIm, the study’s PI is registered in the GIR management application in order to receive communications. This can be done through this link: : https://portal.idiapjgol.org:6443/gir/login/alta_externa.php

“Once the documentation has been validated, an email will be sent to notify receipt

How to present the response to the requested clarifications?

If the CEIm requests clarifications regarding the submitted documentation, the study’s PI will receive an email with the instructions.

They must submit:

  • An explanatory letter with the response to the requested clarifications
  • Modified documents with tracked changes and a new date and version (e.g., Version 2. Date 15/02/2025)
  • A clean version (final version)

How to submit amendments?

To submit an amendment to a project previously approved by the CEIm of IDIAP, you must send an email to cei@idiapjgol.org stating the study title, the CEIm code, and providing the following documentation:

  • Explanatory letter of the changes made
  • Modified documents with tracked changes, new date, and version. Example: Version 2. Date 15/02/2025
  • Clean version (final version)

Contact

Secretary of the CEIm of IDIAPJGol

Gran Via de les Corts Catalanes 587, àtic

 93 482 46 04

 cei@idiapjgol.org