is a biological samples quality
management and

Applicable Legislation

Biomedical Research

  • Law 14/2007 of July 4 of Biomedical Research
  • Royal Decree 1716/2011 of November 18 , which establish the basic requirements of authorization and operation of biobanks for purposes of biomedical research and the Treatment of biological samples of human origin, and rules the Operation and organization of the National Biobank Registry for biomedical research.

Clinical Trials

  • Royal Decree 1090/2015 of December 2, which regulate Clinical Trials with drugs.
  • Regulation (EU) No 536/2014 of the European Parliament and the Council of  April 16, 2014 on clinical trials on medicinal products for human use.
  • Order SAS /3470/2009 of December 16th, about post-authorization studies of observational type for drugs of human use.
  • Law 14/2002 of November 14th, patient autonomy and rights and obligations regarding information and clinical documentation.

Personal Data Protection

  • Organic law 15/1999 of December 13 of personal data protection.
  • Royal Decree 1720/2007 of December 21, wich approves the regulation of the development of the Organic law 15/1999.
  • Code for Data Protection in Clinical Research and Pharmacovigilance. Farmaindustria.

Regulation on Transport of Biological Samples

  • Guide on the regulation on Transport of infectious substances 2011-2012. world Health Organization WHO/ HSE/ IHR 2010.8.
  • Royal Decree 65/2006 of January, 30. Its establishes the import and export requirements for biological samples to be diesgnosed or researched in humans.
  • SAS/ 3166/2009 Order, November, 16. It replaces Royal Decree 65/2006, January, 30,  annexes and establishesrequirements for biological samples import and export
  • Guide on the regulation on Transport of infectiuos substances 2001-2012. World HealthOrganization. WHO/ HSE/ IHR/ 2010.8

Good Practice Guides

  • WMA Helsinki Declaration- Ethical Principles for Medical Research in Humans
  • Council of Europe Convention for the Protection of Human Rights and Human Dignity concerning Biological and Medical Applications, signed in Oviedo on April 4, 1997. It entered into force in Spain on January 1, 2000
  • Charter of Fundamental Rights of the European Union (2000/ C 364/01)
  • Clinical Good Practice Guidelines (PCBs) of the International Conference on Harmonization (ICH) of the Technical Requirements for the Registration of Medicinal Products for Human Use, 1996 (CPMP/ ICH/ 135/95)
  • ISBER Best Practices guidelines. International Society of Biological and Environmental Repositories, 2012.
  • NCI Best Practices for Biospecimen Resources. Revised 2010.
  • OECD Best Practice Guidelines for Biological Resource Centres
  • IARC Common Minimum Technical Standards and Protocols for Biological Resource Centres dedicated to Cancer Research. 2007
  • Code of Good Practice applicable to Biomedical Research Biobanks in Spain, 2012. Instituto de Salud Carlos III (ISCIII)
  • Laboratory Biosafety Manual, 2005 World Health Organization (WHO)
  • Best Practice for Repositories: Collection, Storage, Retrieval and Distributios of Biological Materials for Research. International Society for Biological and Environmental Repositories (ISBER)
  • Best Practice Guidelines for Biological Resource Centres. Organisation for Economic Cooperation and Developement (OECD)
  • Common Minimum Technical Standards and Protocols for Biological Resource Centres Dedicated to Cancer Research. International Association for Cancer Research (IACR)
  • Code og Good Practice for Biobanks. National Biobank Network
  • Guide on Regulation cncerning Transport of Infectiuos Substances. WHO
  • Laboratory Biosafety Manual (WHO)