![]() |
MANAGEMENT OF THE SUITABILITY OF THE SITE'S FACILITIES |
![]() |
The Studies and Agreements Register Unit (UAdEC), associated to the Technical Secretariat of the Germans Trias i Pujol University Hospital (HUGTiP) Research Ethics Committee, is in charge of the management of the suitability of the facilities for clinical trials with medicinal products or medical devices.
-
To request the signature of the suitability of the facilities, you must send the following documents to: uadec.germanstrias@gencat.cat
REQUIREMENTS
-
1. Submit the full protocol (in Spanish or English)
2. State which is the assessing REC.
3. Report on the status of the assessment application (not submitted, under evaluation, approved).
4. Submit the suitability of the site's facilities along with study data and the site’s involved departments.
-
DOWNLOAD THE SUITABILITY OF THE FACILITIES TEMPLATE
PROCEDURE
1.The sponsor will submit the required documents to the following email address: -uadec.germanstrias@gencat.cat.
-
2. The UAdEC will examine the documents and will have them signed by the designee of the HUGTiP Management.
-
3.Finally, the UAdEC will return the signed and scanned document to the applicant. If you may need the original document, you should make the person in charge aware of this.
|
|
Once you receive the signed document on the suitability of the facilities, you shall initiate the process for the Gestión Administrativa del Contrato.
To manage the suitability of the facilities of a study carried out in the Catalan Institute of Oncololgy Badalona (ICO), you shall contact Anna Woessner (awoessner@iconcologia.net)
|
|
|
|
 |