Resolution Of 3 September 2015, Of The General Directorate Of Basic Services Of The National System Of Health And Pharmacy Portfolio, Establishing The Specific Requirements Of The Monitoring Studies Included In Annex Ii...

Original Language Title: Resolución de 3 de septiembre de 2015, de la Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud y Farmacia, por la que se establecen los requisitos específicos de los estudios de monitorización incluidos en el anexo II...

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-10190

The first additional provision of the order SSI/1356/2015, of 2 July, that amending annexes II, III and VI of the Real Decree 1030 / 2006, of 15 September, which establishes the portfolio of common services of the national system of health and the procedure for its updating, and regulate the studies of monitoring techniques , technologies and procedures, notes that within a maximum period of two months from the entry into force of this order shall be established by resolution of the titular person of the General Directorate of basic services of the national system of health and pharmacy portfolio, technical requirements specific to each of the monitoring studies referred to in annex II of the aforementioned regulation , on the proposal of the Committee on benefits, insurance and financing.

That resolution also will determine the Agency which will be responsible for the technical coordination of the study, having, in his case, the favourable report from the corresponding autonomous community.

To make effective such forecast, on 2 September 2015 submitted to the Commission's performance, quality assurance and financing the content of this resolution, which establishes specific requirements for the implementation underway of the mentioned monitoring studies.

In application as provided in the first additional provision of the order SSI/1356/2015, of 2 July, this General direction resolves: first.

Agencies that will technically coordinate the monitoring studies referred to in annex II of the order SSI/1356/2015, of 2 July, that amending annexes II, III and VI of the Real Decree 1030 / 2006 of 15 September, which establishes the portfolio of common services of the national health system and the procedure for its updating , and are regulated studies monitoring techniques, technologies and procedures, prior favourable report respectively of Basque country and the Canary Islands, will be: monitoring agency biodegradable esophageal Stent studies.





Agency for the evaluation of health technologies of the Instituto de Salud Carlos III.






Endobronchial valve.





Service evaluation and planning of the service Canary health (SESCS).






Percutaneous mitral valve using clip repair system.





FLCS-health technology assessment service. Department of health of the Basque Government.






The left atrial appendage closure (Occluder) device.





Agency for the evaluation of health technologies of the Instituto de Salud Carlos III.





Second.

The application of the system of collection of information studies of monitoring (SIEM) that will be accessible through the website of the Ministry of health, social services and equality may be used to facilitate receipt by coordinating agencies of information provided by the participating centres in these four monitoring studies. The General Sub-Directorate of basic services of the national system of health and Cohesion Fund portfolio will be put in knowledge of the participating centers, the respective autonomous communities and coordinating agencies date from which will be available such application.

Third party.

The participating centers will be registered in the general register of centres, health services and facilities (REGCESS) and have inexcusably sanitary authorization of the corresponding autonomous community in accordance with the provisions of the Royal Decree 1277 / 2003 of 10 October, which lays down the General bases on authorization of centers, health services and facilities, with at least the following healthcare services : Studies of monitoring healthcare services biodegradable esophageal Stent.





General surgery and digestive system.

Digestive system.

Radiology (vascular and Interventional Radiology).

Anesthesia and resuscitation.

Intensive medicine.






Endobronchial valve.





Pulmonology.

Thoracic surgery.

Anesthesia and resuscitation.

Intensive medicine.






Percutaneous mitral valve using clip repair system.





Cardiology.

Cardiac surgery.

Hemodynamics.

Anesthesia and resuscitation.

Intensive medicine.






The left atrial appendage closure (Occluder) device.





Cardiac surgery.

Cardiology.

Hemodynamics.

Anesthesia and resuscitation.

Intensive medicine.





To do this, copy the corresponding authorization from the autonomous community with the document of accession of the participating centres shall be sent to referred to in the fourth point.

Room.

Annexed to this resolution the model of adherence of the participating centers is included in these four monitoring studies, with the approval of the managing director of the Centre and the respective autonomous community. In the course of an autonomous community to opt for an alliance between centers to participate in a study of monitoring the accession document will pick up this circumstance, with the approval of the direction of the centres where they are located, services or units that are part of the Alliance. This document, once completed, will be forwarded by the community to the General Sub-Directorate of basic services of the national system of health and Cohesion Fund Portfolio.

Fifth.

This resolution shall enter into force the day following its publication in the "Official Gazette".

Madrid, September 3 2015.-the General Director of basic portfolio of services of the national system of health and pharmacy, Agustín Rivero Cuadrado.

Annex document of accession of the participating centers in monitoring studies D...., responsible for clinical monitoring study... will carry out in the health care service/unit... hospital, says that: a. is informed that the above technique is currently subject to monitoring in the national system of health research, as it determines the order SSI/1356/2015 , 2 July, by which modify annexes II, III and VI of the Real Decree 1030 / 2006, of 15 September, which establishes the portfolio of common services of the national system of health and the procedure for its updating, and regulate the studies of monitoring techniques, technologies and procedures.

B. the Center has been designated by the autonomous community to participate in the study of monitoring.

C. the service/care unit brings together experience, technical conditions and the human and material resources needed to carry it out with sufficient guarantees for the users.

By virtue of all this, expressed their desire to participate in the study of the monitoring of, and accepts the following commitments: 1. fully endorses the content of the agreed protocol for the development of the study of monitoring...

2 it is assumed that the technical coordination of the monitoring study will be carried out by the assessment... Authorized, therefore, the agency that coordinates the study to use the information required to carry it out, guaranteeing the confidentiality of the data of the patients, in accordance with the legislation in force.

3. is committed to submit information regarding their patients, referred to in the Protocol in the form and time limits that are established, guaranteeing the confidentiality of the information in this. Also the signing of this document means that it will not transfer data to other studies without express authorization of the General Directorate of basic services of the national system of health and pharmacy portfolio.

4 inform patients that applies the above-mentioned technique that is subject to monitoring study, which shall be recorded in the informed consent document signed for that purpose. Inherent in all clinical research ethical principles are preserved.

5 given acknowledge that it may be removed at any time from participation in the study of monitoring, which should communicate in writing the corresponding autonomous community to the General Sub-Directorate of basic services of the national system of health and Cohesion Fund Portfolio, and therefore from that moment the Center not may continue to technique subjected to monitoring research as part of the common services portfolio.

In accordance with previous commitments test clinical Manager endorses this document on membership with the approval of the Managing Director of the Centre and the respective autonomous community.

En.........................., a......... de......................... de 201....
Fdo:.......................................................................................

Cargo …………………………………………………………………..

Responsible for clinical monitoring study D..., Managing Director of the hospital... agrees that the Centre: to) verify that monitoring study met the requirements demanded by current legislation in this field, especially those relating to the precise health products for the use of the technique to monitoring research.

(b) adhere to the economic conditions agreed with the companies as provided for in article 8 of the order SSI/1356/2015, of 2 July.

And it gives approval to the participation of the Centre in the study of monitoring under the conditions expressed above.

Fdo: .......................................................................................

Director Gerente del .......................................................................................

D..., certifies that the Center has the required authorization from the autonomous community of the healthcare services of the participating units in the mentioned study (attached authorization) and gives the approval of the autonomous community to the participation of the Centre in the study of monitoring under the conditions expressed above.

Fdo:.......................................................................................

Comunidad Autónoma.....................................................................................................

Cargo ….............……………………………………………………………………………….