NLGeneralInformation object

Applied regulatory conventions

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
Institutional regulatory requirements

Applicable national laws

Data protection act, Hospital act (if patients are being recruited), Genetical engineering act (if samples are taken for genetic analysis);

Additional Information

ICH-GCP Guidelines, International, European, National and Regional regulatory requirements applicable if participants are ‘patients’. Otherwise, institutional guidelines and regulatory requirements only.

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