At INiBICA we carry out the contractual management, monitoring and billing of Clinical Trials, Observational Studies and Clinical Research with Medical Devices.
We are also a link with the provincial Ethics Committee and Public Centers.
1. Contract management
- Advice on Clinical Trials, Observational Studies and Clinical Research with commercial health products, both for researchers and companies (promoters, CROs…).
- Management of economic contracts. The Andalusian Public Health System has a single contract model for conducting clinical studies, which regulates the legal and economic aspects of the parties.
- Other administrative procedures linked to the signing of contracts:
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- Documents required by the regulatory authorities (Suitability of Facilities, in those cases where appropriate).
- Exemption from administrative management of contracts, in the cases in which it proceeds.
- Local documents (Provincial Ethics Committee).
- Support to the Provincial Committee and Centers in the management of documentation in relation to Clinical Studies:
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- Favorable opinion.
- Center Compliance.
- Documents in electronic format:
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- The contract model, in Word format, which contains the clauses and legal provisions:
- The model of Economic Report (ER), in Excel format, which contains the budget of the study:
- Annex 2 to the contract, in Excel format, specifying the breakdown by visits, additional payments and extraordinary direct costs, as well as billing data, if applicable:
- Annex 3: Authorization of the sponsor for the publication of information regarding the status and other basic data of the clinical investigation:
- Annex 4: Additional agreements to the contract model.
- Annex 5: Supply of Medication / Health Product.
- Circuit of signatures according to each Center.
- Management of the start-up of the study, opening, execution and closure of the study.
2. Billing
- Issuance of the first administrative management invoice, after signing the contract.
- Economic follow-up and invoicing of clinical studies.
- Management procedures in application of the economic items for the Promotion of R+D+i and the Research Team.
3. Structure of the Clinical Trials Management Area
– Head of Clinical Trials Area: Mónica Saldaña.
– Coordinator of Clinical Studies: Laura Quintana.
– Clinical Studies Management Technician: Irene Andría Retes.
– Contact: irene.andria@juntadeandalucia.es / irene.andria@inibica.es.
