Clinical trials, post-authorization studies (EPAs) and clinical research with medical devices must have a signed contract between the sponsor, the site, and the managing entity before the initiation of the study. The contract must reflect the responsibilities of the parties in the conduction of the study and the economic aspects.
The Public Health System of Andalusia (SSPA) has a unique model of economic contract for conducting clinical studies according to the resolution of October 16, 2018, of the General Secretariat of Research, Development, and Innovation in health. This contract is composed of the following documents in electronic format:
- The contract template, in Word format, containing the clauses and legal provisions
- The budget template, in Excel format
- Annex 2, in Excel format, specifying 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 regarding the status and other basic data of the clinical study
- Annex 4: Additional agreements to the contract model
- Annex 5: Supply of medication / medical device
The process for the contractual and economic management is included in the "Guía para Promotores y CRO para realización de los trámites económico-administrativos para la participación de los centros sanitarios en los Ensayos Clínicos en el SSPA" only available in Spanish.