Requirements for the presentation of clinical trials and their amendments

If you would like our Clinical Research Ethics Committee (CEIm) to be the CEIm for your drug clinical trial, you must send an application email to ceic@vhir.org, indicating the study information and the approximate date or month of presentation thereof.

If not presented on the expected date, you must re-apply and report the new presentation date, as the request is not acted upon unless such a change is reported.

Presentation of the clinical trial

Timeframe for clinical trial presentation: It can be presented any day of the month. The application must be presented in full, including part I and part II thereof.

All documentation must be presented exclusively in email format via ceic@vhir.org.

All documentation may be written in English, except for the following documentation, which must be presented in Spanish:

Study summary
Patient information leaflet and informed consent
Documentation addressed to the patient

In the case of clinical trials with drugs, this documentation must be presented electronically, via the Clinical Test Management Portal on the Ministry of Health and Social Policy's website.

Requirements for the submission of requests to the CEIm

Clinical trials and relevant amendments:

The requirements set forth in RD 1090/2015 are followed. We attach the documents as a guide for each presentation, with the CEIm requirements stated:

Initial request - requirements: Request for the evaluation of a clinical trial.
Relevant amendments - requirements: Request for the evaluation of an amendment to a clinical trial.
Information on Immediately applicable amendments and stopping a clinical trial.

Evaluation

A weekly meeting is usually arranged. The CEIm distributes and organises the presentations validated in the meeting at its discretion, depending on the total entries received, but always following the evaluation calendar, in accordance with RD 1090/2015.

You can refer to our meeting schedule.

Proof of receipt

The CEIm will not issue proof of having received the documentation by email. If you need proof of receipt, request confirmation of receipt in the email you send.

Proof of receipt from the Clinical Test Management Portal on the Ministry of Health and Social Policy's website is in itself proof of receipt for clinical trial presentations, submitted documentation amendments, and responses to clarifications for an initial application/amendment.

Contact

If you have any queries, contact the CEIm Support Unit:

13th floor of the Children's Hospital and Women's Hospital
Passeig Vall d'Hebron n. 119-129
08035 Barcelona
Phone: (+34) 93 489 40 10
Email address: ceic@vhir.org

Contract and billing

To request the contract model, the economic report or any question regarding the contract / economic report: Review the Clinical trials / Contractual and economic management section on the Foundation's website.

For any questions regarding invoicing, contact the Department of Economic Management of the Foundation: facturacion@vhir.org.

Processing of the suitability of the centre

The Vall d'Hebron University Hospital requires signatures from the following:

The principal investigator's department head
General Manager of the Vall d’Hebron Research Institute Foundation (VHIR)

To request the signature of the director of the VHIR Foundation, contact the Legal Department of the Foundation: Review the Clinical trials / Contractual and economic management section on the Foundation's website.