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“We’re counting on you!Your collaboration and help is what allows us to continue working to improve the quality of life of our patients.The high technical and human qualifications of the research staff make this hospital one of the most prestigious in Spain. With your support, we will continue to move forward to improve the lives of many people.”
BIZUM Code
01171
Donation templates
Contact details: Ana Aroca
secfundacion.hlpr@salud.madrid.org
Telephone: + 34 91 520 24 76
Services
- Evaluation of the methodological and legal aspects of Clinical Trials.
- Management of contracts for Clinical Trials and Observational Studies.
- Billing for clinical trials/studies.
- Trial follow-up.
- Management of clinical trials/studies accounts.
- Information and Payments to Researchers.
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.
- Protocol
- Insurance certificate that includes the IP, FIB and the Hospital
This documentation should be sent to:
eecc.fib.hlpr@salud.madrid.org or administracion.fib.hlpr@salud.madrid.org 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).
To process an Observational Trial Contract, the following documentation must be submitted:
- Completed contract template. It is available in Spanish and bilingual version (May 2018 version).
- General financial report for the Observational Study submitted/accepted by the CEIm
- 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.
- Classification of the AEMPS
- Protocol
This documentation should be sent to:
eecc.fib.hlpr@salud.madrid.org or administracion.fib.hlpr@salud.madrid.org 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 entails a single payment, upon signing the Contract, and regardless of the number of patients included in the trial, of €300 (VAT not included).
To process an Addendum to a Clinical Trial/Observational Study Contract, the following documentation must be submitted:
- Completed addendum template. It is available in Spanish and bilingual (May 2016-2 version).
- Documents justifying the addendum
- CEIm approval/notification
This documentation should be sent to:
eecc.fib.hlpr@salud.madrid.org or administracion.fib.hlpr@salud.madrid.org for Amendment negotiation or management.
2- Processing signatures
Three copies of the Contract Addendum 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 an Amendment to a Clinical Trial/Observational Study Contract entails the single payment, upon signature of the Addendum, of €200 (VAT not included).
Contact details:
Sara Cardenal Rodríguez
Clinical Trials Director
Contract and Agreement Templates
Contact details: María Jesús Bono Sahuquillo
legal.fib.hlpr@salud.madrid.org
Telephone: + 34 91 520 24 76
It is therefore very important that we create synergies with companies or centres interested in participating as research project partners or coordinators.
Contact person
Jesús Santamaria Pérez
proyectos.fib.hlpr@salud.madrid.org
Telephone: + 34 91 520 24 76
