ECRIN CAMPUS for Regulatory and Ethical Requirements
ECRIN CAMPUS is a central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies. Use CAMPUS to locate country-specific competent authorities and ethics committees, consult the summary of requirements for each country, compare country information, and browse related documents (e.g., regulations and guidelines). All information from the Treat-NMD Regulatory Affairs Database and Medical Device Toolkits (see below) is included in CAMPUS.
Treat-NMD Regulatory Affairs Database
The Treat-NMD Regulatory Affairs Database contains regulatory, clinical trial information for 18 European countries. It includes contact addresses of national authorities, national legislation and documents and European and international regulations, including regulations on orphan drugs. This database has been established by the TREAT-NMD Neuromuscular Network in cooperation with ECRIN.
Regulatory and Ethical Requirements in Medical Device Studies: Toolkits
Toolkits have been prepared, for training purposes, with country-specific information on regulatory and ethical requirements in medical device studies. You can find the definition and legal basis for medical device studies; information on insurance, sponsors, investigators, competent authorities, ethics committees, data protection, and healthy volunteers/patients; and specific requirements on registries, monitoring and informed consent.