Facility Suitability Management
Management of the contract and the financial report
Invoicing
Frequently asked questions and download links
Management of the Clinical Trial contract

Once the Facilities Suitability Document has been processed by INCLIVA’s Clinical Trials Unit, the Promoter or CRO must send the completed Clinical Trials Contract Model (Spanish and bilingual Spanish/English)

They must also download and fill in the INCLIVA’s Economic Report Model for the Sponsor.

Both documents, duly completed, must be sent to the e-mail address contratoseecc@incliva.es

  • Approval of the CEIm. *
  • AEMPS approval or CTIS document containing the relevant authorisations. *
  • Certificate of Insurance Policy with the details of the Clinical Hospital, the INCLIVA Foundation and the PI.
  • Power of attorney of the signatory by the Sponsor or the CRO and delegation to the CRO, if applicable. Duly apostilled if issued by notaries outside Spain.
  • Confirm supply of medication (if applicable) *.

*The fully signed contract will remain in the custody of the INCLIVA Foundation until the opinions and authorisations of the competent committees and administrative authorities have been sent to the management of contratoseecc@incliva.es.

NEGOTIATION OF THE FINANCIAL REPORT:

Depending on the lead department of the trial or study, the negotiation of the financial report will be carried out with the following contacts:

– Haematology: Eva Barri ebarri@incliva.es

– Oncology: Enrique Castelló ecastello@incliva.es

– Other Services: Manu Erasun merasun@incliva.es

Management of observational study contracts

The Sponsor must contact the contratoseecc@incliva.es e-mail account providing:

  • Basic data of the Study (Sponsor Code, Principal Investigator and Conducting Service).
  • Completed INCLIVA contract form:
    • Observational study with medicine or medical device (Spanish and bilingual).
    • Post-authorisation contract for an observational study of a medical device with ce marking with the research centre (Spanish).
  • General economic report of the Sponsor and INCLIVA’s economic report for the Sponsor.
  • Powers of attorney of the signatory and delegation to the CRO, if applicable and duly apostilled if necessary.
  • Approval of the CEIm.
  • Authorisation from the AEMPS when required due to the characteristics of the study.

*The fully signed contract will remain in the custody of the INCLIVA Foundation until the opinions and authorisations of the competent committees and administrative authorities have been sent to the management of contratoseecc@incliva.es.

Addenda

The Sponsor must contact the e-mail account of contratoseecc@incliva.es providing:

  • Basic data of the Study (Promoter Code, Principal Investigator and Conducting Service) and the reason(s) for the Addendum.
  • Completed INCLIVA addendum form (Spanish and bilingual).
  • When necessary, the Sponsor’s general economic report and INCLIVA’s economic report for the Sponsor
  • If the signatory of the Sponsor has changed with respect to the contract or addendum previously managed, powers of attorney of the signatory and delegation to the CRO, if applicable and duly apostilled if necessary.
  • Approval of the CEIm and authorisation of the AEMPS when the characteristics of the addendum so require.*

*The fully signed addenda will remain in the custody of the INCLIVA Foundation until the opinions and authorisations of the competent committees and administrative authorities have been sent to the management of contratoseecc@incliva.es

Exemption from contract management costs or addenda:

In order to apply for exemption from contract management costs or addenda under management, the following requirements must be met:

  1. a) That the research to be carried out is independent.
  2. b) That the Sponsor of the study is a private non-profit research entity, a public research entity, including the care centres of the Regional Ministry of Health, or a researcher on the staff of public research entities, including the care centres of the Regional Ministry of Health.
  3. c) That no external private funding has been obtained to carry out the study.
  4. d) That the researchers will not receive any type of remuneration for their participation in the study.

You can download and fill in the corresponding application form here.

Facility Suitability Management

Manu Erasun
ensayosclinicos@incliva.es / merasun@incliva.es
Phone: 961 62 89 21

Contracts and addenda

contratoseecc@incliva.es

Invoicing

Mayca Román
facturacioneecc@incliva.es / mroman@incliva.es

Documents

Rates