NLGeneralInformation object

Applied regulatory conventions

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
ICH-GCP Guidelines
Other guidelines for good clinical practice (other than ICH-GCP)
International regulatory requirements
European regulatory requirements - European Directive 2001/20/EC, 2005/28/EC
National regulatory requirements
Regional regulatory requirements
Institutional regulatory requirements

Applicable national laws

Hospital Act
Data protection Act
Genetical engineering act
Medical device act
Drug act

Network providing information on regulations and ethical requirements in studies

Portuguese Clinical Research Infrastructure Network - PtCRIN

Network Email

ptcrin@fcm.unl.pt

Network contact person

Ana Pais

Personal Email

ana.pais@fcm.unl.pt

Official website providing relevant national legislation available

Yes

Official website providing relevant national legislation

http://web.fcm.unl.pt/ptcrin/

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback