Site Suitability Management Procedure

The Site Suitability document may be requested via the following email address (ensayosclinicos@incliva.es) set up by INCLIVA for this purpose.

To apply, send an email listing basic study details (Code, EUDRACT, Principal Investigator and Department) and attaching the following documentation:

  1. Study Protocol
  2. Annual Economic Report

On receiving the application INCLIVA will contact the Principal Investigator to confirm participation of other departments involved and will then obtain the Centre signature.
Following this, it will be sent to the Sponsor or CRO to the applicant’s email.

Contract Management Procedure

Una vez realizada la gestión del Documento de Idoneidad de las Instalaciones, desde la Unidad de Gestión de Estudios Clínicos de INCLIVA, se remitirá al Promotor/CRO el modelo de contrato vigente en la Comunidad Valenciana.

While the contract is being negotiated, the Principal Investigator will be contacted internally to define the team who will collaborate in developing the study, request authorizations from the departments involved and adapt the Study Economic Report to the specific report of the contract model.

Commitment of the principal investigator and authorisation of the head of department

Conformity of the services involved

To complete these procedures, the Promoter/CRO must submit the following documentation:

  • Annex 1A
  • CEIm approval*
  • AEMPS approval*
  • Insurance Policy Certificate
  • Power of Attorney
  • Confirm medical product supply (if applicable)

*If approval has not been obtained at the time of contract signing, it must be sent as soon as available.

Signature Circuit

After the contract has obtained definitive approval, INCLIVA’s Clinical Studies Management Unit will send the Promoter/CRO the final file in PDF. The signature circuit will be agreed upon between INCLIVA and the Promoter/CRO.

The contract will be signed electronically.

Site Suitability

ensayosclinicos@incliva.es
apons@incliva.es
Telephone: 961 97 39 76

CEIm

ceic_hcv@gva.es
Telephone: 961 97 39 76