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
Institutional regulatory requirements
Applicable national laws
Hospital Act
Data protection Act
Genetical engineering act
Medical device act
Drug act
hospital act applies only if study is performed in the hospital setting, Genetical engineering act, Medical device act and drug act only in relevant context
