To process a Clinical Trial Contract, the following documentation must be submitted:
- Completed contract template and annexes. The contract template available is that established by the Department of Health of the Comunidad de Madrid, suitable for the Institute and accepted by FarmaIndustria. It is available in Spanish and bilingual version (May 2018 version).
- General financial report for the Clinical Trial submitted/accepted by the CEIm
- Pharmacy Compliance (Institute-specific document)
- Extraordinary Evidence Document (Institute-specific document)
- In case of proxy signature of the Contract on the part of the Promoter, powers of representation elevated to a public level or with an Apostille from The Hague are required.
- Insurance certificate that includes the IP, FIB and the Hospital
This documentation should be sent to:
firstname.lastname@example.org or email@example.com for Contract negotiation or management.
2- Processing signatures
To sign the Contract, approval is required from the Committee on the adequacy of research studies.
Three copies of the Contract must be signed unless expressly indicated otherwise.
The signature process will be conducted as follows: Directorate of the Foundation, Promoter, Lead Researcher and Management.
3- Management expenses
The negotiation and administrative management of the contract entail a single payment, upon signing the Contract, and regardless of the number of patients included in the trial, of €800 (VAT not included).