Andalusia defines the new contract models for clinical trials and observational studies
El Official Gazette of the Junta de Andalucía includes the Resolution of June 13, 2019, of the General Secretariat for Research, Development and Innovation in Health, which approves the models of economic contracts for conducting clinical trials, observational post-authorization studies with medicines for human use and clinical research with health products in the public health system of Andalusia. With it, the Resolution of November 23, 2013, of the General Directorate of Quality, Research, Development and Innovation is annulled.
In the explanatory statement, the General Secretariat for Research, Development and Innovation in Health, promoter of this new standard, explains that "the usual practice of carrying out clinical trials with medicines, the changes in the regulation introduced by Royal Decree 1090 /2015, of December 4, as well as the experience obtained during the time elapsed since the single contract model for the Andalusian health system was approved by Resolution of November 23, 2013, of the General Directorate of Quality, Research, Development and Innovation (Official Bulletin of the Andalusian Government No. 239, of December 5, 2013), which replaced the one approved by Resolution of May 23, 2006, require the approval of a new contract model that conforms to the practical reality and reflect new regulations, such as the concept of clinical trials with a low level of intervention, informed consent, the intervention of Ethics Committees of Research in clinical trials that must be accredited as Research Ethics Committees with medicines and the Spanish Registry of Clinical Studies”.
They also justify the adoption of this new Resolution with the necessary adaptation to "practice and background" since the approval of the contract model for post-authorization observational studies with medicines for human use, through Royal Decree 577/2013 and the Order SAS/ 3470/2009, and with the obligation to establish a model of economic contract for clinical research with medical devices, which unifies the various types used in the centers of the Andalusian Public Health System. Said investigations have been regulated by Regulation (UE) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices.
The General Secretariat for Research, Development and Innovation in Health undertakes, through this Resolution, to establish whatever actions are necessary in the development, application, evaluation and control of the economic contract models.
Possible substitution
Regarding the attached model contracts, these may be replaced by others that are established or required to participate in European or national projects, provided that they are compatible, qualify, with the content and principles of the contract models that approves the resolution.
In addition, when necessary for one of the parties, new clauses or commitments may be added to the contract models included in the Resolution, provided that they are compatible with their content and principles, in accordance with the provisions of the regulations. in force on the matter and in accordance with Annex 4 of each type of contract. If new clauses are proposed in a language other than the official language of the Spanish State, they must be accompanied by a sworn translation into Spanish.