Clinical trials,Observational Post-Authorization Studies* and Clinical Investigacion with Medical Devices (hereinafter, Clinical Studies) require the signing of a contract between the Sponsor, the Healthcare Centre and the Managing Body of the Research, Development and Innovation of the Centre before the start of the study, setting out the responsibilities of the parties in the development of the study and the economic aspects.
The Andalusian Public Health System adopted a unique model of economic contract for conducting Studies in accordance with the Resolution of June 13, 2019, of the General Secretariat for Research, Development and Innovation, which approves the models of economic contracts for conducting clinical trials, observational post-authorization studies with medical products for human use and clinical investigations with medical devices in the Andalusian Public Health System (Published in BOJA No. 118, of June 21, 2019).
This contract is made up of the following documents in electronic format:
- The contract model, in Word format, containing the clauses and legal provisions
- Annex 1, in Excel format, which contains the breakdown of the study budget.
- Annex 2, in Excel format, which specifies the breakdown by visits, additional payments, and extraordinary direct costs, as well as invoicing information, if applicable
- Annex 3, Authorization of the sponsor for the publication of information related the status and other basic data of the clinical study
- Annex 4: Additional agreements to the model contract.
- Annex 5: Supply of Medication/Medical device
The model contracts and their annexes are available in both Spanish and English.
The circuit for the contractual and economic management is included in the Guide for Sponsors and CRO for conducting Clinical Studies in which Andalusian Public Health centers participate.
* On January 2, 2021, Royal Decree 957/2020, of November 3, came into force, regulating observational studies with medicines for human use, published in BOE no. 310, of November 26, 2020. For this reason, the current contract model for conducting observational studies, approved by the Resolution of May 28, 2019 of the General Secretariat for Research, Development and Innovation in Health, requires an update, whose procedure is being processed by the competent administrative services of the Ministry of Health and Family of the Junta de Andalucía. The references included in the contract model for conducting post-authorization studies to SAS Order 2470/2009, of December 16, which published the guidelines on observational post-authorization studies for medicines for human use, published in the BOE no. 310, of December 25, 2009, will be considered as made to observational studies in accordance with the content of Royal Decree 957/2020, of November 3, which regulates observational studies with medicines for human user, not applying, therefore, the classification of studies referred to in such contract. Please, contact us for more information.