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Quality and legislation

Quality
Legislation

Quality

The IDIBGI Biobank has implemented a quality management system in accordance with the ISO 9001:2015 standard for the integral management of human samples and associated data for biomedical research.

Legislation

The IDIBGI Biobank is governed by the following legal framework:

  • BOE no. 274 dated 15/11/2002. Law 41/2002, dated November 14, as the basic regulator of the autonomy of the patient and their rights and obligations in the terms of information and clinical documentation.
  • BOE no. 159 dated 04/07/2007. Law 14/2007, dated July 3, regarding Biomedical Research.
  • BOE no. 290 dated 02/12/2011. Royal Decree 1716/2011, dated November 18, establishing the basic requirements for the authorization and operation of biobanks for the purposes of biomedical research and the treatment of biological samples of human origin, and regulating the operation and organization of the national biobank registry for biomedical research.
  • BOE no. 177 dated 25/07/2013. Order ECC/1404/2013, dated June 28, which modifies the annex of Royal Decree 1716/2011, dated November 18, which establishes the basic requirements for the authorization and operation of biobanks for the purposes of biomedical research and the treatment of biological samples of human origin, and by which the operation and organization of the National Biobank Registry for Biomedical Research is regulated.
  • DOGC no. 6482 dated 17/10/2013. Decree 234/2013, dated October 15, which regulates the authorization for the constitution and the operation of biobanks for the purposes of biomedical research in Catalonia and the Catalan Biobank Network.
  • BOE no. 307 dated 24/12/2015. RD 1090/2015 dated December 4, which regulates clinical trials with drugs, Ethics Committees for drug research and the Spanish Registry Of Clinical Studies.
  • DO L 119 de 4/5/2016. European Parliament and the Council for the Protection of Physical Persons Regulation (EU) 2016/679 with regard to the treatment of personal data and the free circulation of these data and by which Directive 95/46/EC (General Regulation of Data Protection) is repealed.
  • BOE no. 294 dated 06/12/2018. Organic Law 3/2018 dated December 5, regarding personal data protection and guarantee of digital rights.

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