Contracts and Financial Reports Management

Management of clinical trial contract

Once the management of the Facility Suitability Document has been completed by the Clinical Trials Unit of INCLIVA, the sponsor or CRO (Clinical Research Organization) must send the Clinical Trial Contract Template (Spanish and bilingual Spanish/English) and the INCLIVA’s sponsor Financial Report Template duly completed.

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

For the final signature of the contract, the following documentation must be submitted by the sponsor/CRO:

• Approval of the CEIm (Ethics Committees for Investigation with medicinal products). *
• Approval of the AEMPS (Agencia Española del Medicamento y Productos Sanitarios – Spanish Agency of Medicines and Medical Devices) or CTIS (Clinical Trials Information System) document stating the relevant authorizations. *
• Insurance policy certificate including the details of the Hospital Clínico Universitario de València, the INCLIVA Foundation, and the Principal Investigator (PI).
• Notarial powers of attorney of the signatory on behalf of the sponsor or the CRO and delegation to the CRO, if appliable. Duly apostilled if issued by notaries outside Spain.
• Confirmation of medication supply (if aplicable).

*The fully signed contract will remain under the custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to contratoseecc@incliva.es.

NEGOTIATION OF THE FINANCIAL REPORT:

According to the Main Department of the trial or study, the negotiation of the financial report will be carried out with the following contacts:

• Hematology: Eva Barri ebarri@incliva.es
• Oncology: Enrique Castelló ecastello@incliva.es
• Other Departments: Manu Erasun merasun@incliva.es

Management of contract for observational studies

The sponsor must contact the email account contratoseecc@incliva.es providing:

• Basic study information (sponsor code, Principal Investigator, and Performing Department).
• INCLIVA contract template completed:
  • Observational study with medicinal product or medical device (Spanish and bilingual).
  • Post-authorization observational study contract of medical device with CE marking with the research center (Spanish).
• General financial report of the sponsor and INCLIVA financial report for the sponsor.
• Powers of attorney of the signatory and delegation to the CRO, if aplicable, and duly apostilled if necessary.
• Approval of the CEIm.*
• AEMPS authorization when required due to the characteristics of the study.

*The fully signed contract will remain under custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to contratoseecc@incliva.es.

Addenda

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

• Basic study information (sponsor code, Principal Investigator and Performing Department) and the reason or reasons for the addendum.
• INCLIVA’s addendum template completed (Spanish and bilingual).
• When necessary, the sponsor’s general financial report and INCLIVA’s financial 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 aplicable, and duly apostilled if necessary.
• CEIm approval and AEMPS authorization when the characteristics of the addendum require it.*

*The fully signed addendum will remain under the custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to contratoseecc@incliva.es.

Exemption from contract or addendum management costs:

• • To be able to request the exemption from the management cost of the contract or addendum under processing, the following requirements must be met:
    1. That the research to be carried out is independent.
    2. That the sponsor of the study is a non-profit research entity, a public research entity, including healthcare centers of the Conselleria de Sanidad, or a staff researcher of the public research entities, including the healthcare centers of the Conselleria de Sanidad.
    3. That no external private funding has been obtained for the conduct of the study.
    4. That the research team will not receive any type of remuneration for its participation in the study.

  The corresponding application template can be downloaded and completed here.

Contracts and Addenda

Miguel Roig

contratoseecc@incliva.es

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