Administrative costs

To manage the administrative and contractual aspects of clinical trials, observational studies with medicines for human use and clinical research with health products, a fixed tariff has been established according to the pathology and the complexity of the study. This non-refundable tariff (VAT not included) is outlined in the financial report of the contract.

This amount does not include the fees of the Drug Research Ethics Committee (CEIM) and is not conditional on the assessment of the study.

This amount will be invoiced at the time the contract is signed, without its effective collection being conditional on the performance of the study or its approval by the CEIM and/or Spanish Agency of Medicines and Medical Devices (AEMPS).

On an exceptional basis, for the purposes of promoting and facilitating independent clinical research, this tariff may be partially or fully subsidised by the foundations in the case that all the conditions described below are met.

• The promoter is a university, hospital or public scientific organisation, a not-for-profit organisation, a patients' association or an individual researcher.
• The study is carried out by researchers who have no financial interest in the pharmaceutical industry or health products.
• The study does not involve direct or indirect payments to the researchers.
• The design, performance, recruitment, data collection and communication of results of the research is under the control of the promoters, who meet the indicated conditions and are the owners of the research data.
• There are no agreements between the promoter and third parties that allow them to use the data for regulatory uses or to generate industrial property rights, and the study does not form part of a programme to develop the marketing rights of a product.

If all these conditions are met, the administrative fee subsidy request form (available on the Forms tab) must be presented together with the request for the contractual review of the study. These documents must be sent to the email address memoriaeco.ac@vhir.org for approval.

Contractual review

In order to manage the contract and the financial report of clinical trials, observational studies with medicines for human use and clinical research with health products, the following steps are required:

1. Acquiring, filling in and processing the signatures of the facility suitability document (only applicable to clinical trials and clinical research with health products). Once the Facility Suitability document has been acquired (from the Forms section of our website), the Head of Department involved must sign it and send it by email to the Quality Unit of Document and Process Management: gestio.documental@vhir.org. 
2. Acquiring and filling in the contract, addendum, and financial report forms. The contract, addendum and financial report forms can be found in the Forms section of our website. In the event of queries or concerns regarding the above, please contact us:
   • Queries regarding the contract forms: legal@vhir.org
   • Queries regarding the Financial report and the Request for administrative and management costs subsidy forms: memoriaeco.ac@vhir.org
3. Legal and financial review of the forms
   • Revisió jurídica: Send an email to legal@vhir.org and to gestiorecercaclinica@vhir.org, indicating in the subject the study protocol code and attaching the completed form and the following study documentation:
     • The Suitability of the facilities of our centre document, signed by the Head of Department involved in the study.
     • The study protocol.
     • Appendix A1 (Accompanying letter: Request for new clinical trial) presented to the Spanish Agency of Medicines and Medical Devices (AEMPS) in PDF and XML format.
     • The certificate of civil liability insurance (including our centre).
     • Document demonstrating the contractual delegation of powers over the study of the promoter to the research company (CRO), if applicable.
     • Documents demonstrating the approval of the Drug Research Ethics Committee and the AEMPS when available
     • Once the contract and/or completed addendum are received, and the documents listed above, the legal review will commence and the appropriate legal negotiation, if required.
   • Review of the financial report
     • VHIR+HUVH: Send an email to memoriaeco.ac@vhir.org, indicating the study protocol in the subject and attaching the financial report (available under the Forms section, duly completed.
     • VHIO+VHIR+HUVH: Send an email to ybernabe@vhio.net, indicating the study protocol in the subject and attaching the financial report (available under the Forms section, duly completed. Once the financial report is received, the financial review and subsequent validation by the research team will be performed. In the case of submitting the Subsidy request for administrative and management fees (available under the Forms section), it must be sent for evaluation to memoriaeco.ac@vhir.org.