The CAMPUS Database – launched in December 2015 by the European Clinical Research Infrastructure Network (ECRIN) – is an online database including country-specific information on regulatory and ethical requirements in clinical research across Europe.
Aimed at promoting and facilitating multi-national clinical research projects in Europe, CAMPUS provides simple and easy access to regulatory information for people involved in planning, initiating and conducting clinical trials on a national and international level.
The CAMPUS Database encompasses up-to-date regulatory and ethical requirements applicable to clinical research projects in medicinal products for human use, medical devices, and/or nutrition. It currently includes information for over 22 European countries in these different research fields.
For each study type and country, information can be found on applicable national legislation such as specific aspects and provisions related to competent authorities and ethics committees (contact, application, submission, declaration and reporting obligations) as well as study-specific requirements on study participants, vulnerable population, informed consent, data protection, insurance, etc.
CAMPUS offers a convenient way for users to search for relevant information either by browsing the study types of interest per country or by comparing specific provisions of multiple countries; users can narrow down search results using filters (see guidance on how to use the Database).
The CAMPUS Database was created during the ECRIN-Integrating Activity (ECRIN-IA) project period 2012-2015, with funding from the European Union Framework Program 7 (grant agreement nr 284395).
Specifically, CAMPUS was developed as part of ECRIN Work Packages (WP) 3 (training and e-communication), 5 (medical devices) and 6 (nutrition). To compile data, ECRIN national contact points (European Correspondents) worked in close cooperation with the TREAT-NMD Network and representatives from the European Society for Clinical Nutrition and Metabolism (ESPEN).
Originally developed and managed by ECRIN-IA partners at the Medical University of Vienna, CAMPUS is now maintained and updated by ECRIN (as of start 2016).
Guidance for Users
New data protection law has been adopted !
The French National Medical Council (CNOM) and the CNIL have jointly published a Practical guide to data protection for physicians (available only in French):
Guide pratique sur la protection des données personnelles, Juin 2018
The Federal Data Protection Act of 30 June 2017 (Bundesdatenschutzgesetz – BDSG) (Federal Law Gazette I p. 2097) has been published in English
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