Frequently asked questions and download links

Is a suitability of the facilities with the signature of the PI or the Head of Service valid to manage the contract?
No. The approvals must be signed by the Medical Management of the Hospital Clínico Universitario de València or they will not be accepted as valid to manage the contract.
When can I start to process the contract?
After signing the suitability of the facilities.
What is the amount of the contract management costs or addendum?
500 € for the contract management, 300 € for addenda management.
Is the use of the Promoter’s model contract accepted?
The entity already has a model contract. Only in absolutely exceptional cases and for justified reasons could the Promoter’s model be used.
Does the Foundation accept to negotiate the clauses of the Contract?
Yes, but to a limited extent.
Does INCLIVA have a template of Standard Contract Clauses?
Yes, and its use is mandatory for data transfers to those countries that do not have an ad hoc treaty. In the rest, the Data Protection Agreement included in the template will suffice.
Who initiates the signature procedure?
The Promoter.
Can I sign digitally?
Yes, it is preferred to a physical signature.
Can the contract be signed via Docusign?
There is no problem for the Promoter to use Docusign, but the signatures of the Hospital Management, the Foundation Management and the Principal Investigator will be collected internally.

INCLIVA Model Suitability Facilities
Clinical Trial Contract Model (Spanish and bilingual Spanish/English) .
INCLIVA Economic Report Model for the Sponsor.
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).
INCLIVA addendum model (Spanish and bilingual)
Application form for exemption of management costs.