Introduction
The unit’s objective is to carry out the maintenance of the quality and data protection aspects of the organization, as well as to advise and support the research staff with the needs they may have regarding these two issues.
Likewise, it is the institutional point of contact for any requirement or query regarding the certifications of the INCLIVA Foundation or its data protection policies and actions.
Location
This unit is located in the INCLIVA office building (Pasaje Luz, Álvaro de Bazán, 10. Valencia)
Services
Quality
- Support with compliance with regulatory management requirements
- Support with the design and implementation of management systems for certifications or accreditations
- Information on the certificates and accreditations available for inclusion or reference in the presentation of projects to competitive calls
- Management of compliance with requirements applicable to biomedical equipment linked to competitive research strategies
Data Protection
- Support for data protection planning from the design of the project/research study
- Support with the preparation or review of data protection elements related to projects and studies, such as the following:
- Data Management Plan
- Processing Activity Records
- Impact Assessments
- Treatment order contracts
- Data Transfer Agreements
- Management of data transfers outside the European Economic Area
- Management of incidents or security breaches
- Support with the response to requirements of Authorities, collaborating companies or third parties regarding compliance with data protection regulations
- Support with the management of requests to exercise rights over personal data, from participants in research projects/studies
- Regulations
- Organic Law 3-2018 on the Protection of Personal Data
- EU Regulation 2016-679 data protection RGPD
- Guides
- Opinion 05.2014 on anonymization techniques of the Working Group
- Opinion 15.2011 on the definition of consent Working Group
- Duty to inform guide
- Guide cyber incident management notification
- Report AEPD 2018-0046 -biomedical-research
- Opinion 1.2010 Working group art 29 Responsible
- Opinion 03.2013 on purpose limitation of the Article Working Group …
- Order 7.2019 of June 4, 2019 Rules for the safe use of technological means
- Guidance on anonymization procedures
Responsible for Quality and Data Protection
Rafael Barajas Cenobio
rbarajas@incliva.es
Team
María Domínguez
Contact information
Telephone: 961 62 89 47
calidad@incliva.es