NLGeneralInformation object

Applied regulatory conventions in studies including patients

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
ICH-GCP Guidelines

Applied regulatory conventions in studies including healthy participants

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
Other guidelines for good clinical practice (other than ICH-GCP)

Applied regulatory conventions in studies including vulnerable population

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

Applicable national laws for patients

Hospital Act, Data protection Act, Genetical engineering act (If samples are taken for genetic analysis), Medical device act (If a medical device is being tested),

Applicable national laws for healthy participants

Data protection Act, Genetical engineering act (If samples are taken for genetic analysis), Medical device act (If a medical device is being tested),

Applicable national laws for vulnerable population

Hospital Act ( If patients are being recruited), Data protection Act, Genetical engineering act (If samples are taken for genetic analysis), Medical device act (If a medical device is being tested);

National regulations for volunteers exist for

Isotopes
Tissue samples

Additional Information

Applied regulatory conventions in studies including vulnerable population: required if participants are ‘patients’. Otherwise, institutional guidelines and regulatory requirements only

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