Clinical trials, observational studies and clinical trials with medical devices
INiBICA also acts as a liaison with the provincial Ethics Committee, as well as with public centres.
1. Management of clinical studies where FCádiz acts as a sponsor
Independent Clinical Research Support Service, aimed at researchers who require methodological support, statistical analysis and advice for conducting clinical studies.
2. Contract management.
- Advice on clinical trials, observational studies and clinical trials with commercial medical devices, both to researchers and companies (sponsors, CRO...)
- Management of economic contracts. The Andalusian Public Health System has one single model contract for conducting clinical studies, which regulates the legal and economic aspects of all the stakeholders.
- Other administrative procedures related to the signing of contracts:
-
-
- Documents required by regulatory authorities (Suitability of facilities, where applicable)
- Exemption from administrative contract management (where applicable)
- Local documents (provincial Ethics Committee)
-
- Support to the provincial Ethics Committee and Centres in the management of documents in relation to clinical trials:
-
-
- Favourable view
- Compliance of the Centre
-
- Documents in electronic format:
-
-
- The model contract in Word format, which contains the legal clauses and provisions.
- The Economic Report (ER) template, in Excel format, which contains the budget available for the study.
- Annex 2 to the contract, in Excel format, which specifies the breakdown by visits, additional payments and extraordinary direct costs, as well as invoicing data (if applicable).
- Annex 3: Sponsor's authorization to publish status information and other basic clinical research data.
- Annex 4: Additional agreements to the model contract.
- Annex 5: Supply of medication/medical device.
-
- Signature circuit according to each Centre.
- Management of the opening, execution and closing of the study.
3. Invoicing.
- Issuance of first administrative management invoice, after signing the contract.
- Economic follow-up and invoicing of clinical studies.
- Management procedures as per economic items of R+D+i Promotion and Research Team.
4. Structure of the clinical trial management area
Responsible for the clinical trial area (Pending incorporation)
Clinical trial management technician: Irene Andría Retes
Contact email: irene.andria@juntadeandalucia.es / irene.andria@inibica.es
