Management of the contract and the financial report

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), the Economic Report Model for INCLIVA’s Promoter and the following documentation 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) *.

*If it is not available at the time of signing the Contract, it must be sent as soon as it is available.

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

Basic data of the Study (Sponsor Code, Principal Investigator and Conducting Service).
Protocol
General economic report of the Sponsor and INCLIVA’s economic report for the Sponsor.
INCLIVA contract form completed according to the type of trial:
- 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).
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 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).
In case of amendment to the Protocol, the most recent amendment must be included with the changes highlighted
If the amendment modifies the financial report, the financial report with the highlighted changes must also be submitted.
If the signatory of the Promoter has changed with respect to the previously managed contract or addendum, 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.

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

a) That the research to be carried out is independent.
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.
c) That no external private funding has been obtained to carry out the study.
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.