Note: As of 2023, we are in the process of updating the RED tool ; some information might not be up-to-date.
The Regulatory and Ethical Database (RED) – 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, RED provides simple and easy access to regulatory information for people involved in planning, initiating and conducting clinical trials on a national and international level.
RED encompasses up-to-date regulatory and ethical requirements applicable to clinical research projects in medicinal products for human use, medical devices, and other studies. It also includes a "CTIS (Clinical Trial Information System)" page, to sum-up the new single entry point for clinical trial data in the European Union.
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.
RED 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).
RED, anciently named CAMPUS, 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, it 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, RED is now maintained and updated by ECRIN (as of start 2016).