RED (Regulatory and Ethical Database)

RED (Regulatory and Ethical Database) is ECRIN’s central online resource for navigating national regulatory and ethical requirements for clinical studies across Europe. It targets investigators and sponsors planning, initiating and conducting clinical research, particularly multi‑country trials. By centralising up‑to‑date information from ECRIN’s network of national experts, RED helps identify submission pathways, ethics review structures and national specificities on a single platform, reducing the need to consult separate national sources and supporting efficient, high‑quality multinational research.

Scope and coverage

• Focuses on regulatory and ethical requirements for clinical research on medicinal products for human use, medical devices and other study types such as observational or cohort studies.
• Covers European Union countries and additional states including Switzerland, Turkey, Bosnia and Herzegovina, Serbia, Israel, North Macedonia and Norway

Content and Structure

• Provides country‑specific information on national legislation, competent authorities and ethics committees, plus application, submission (including fees), declaration and reporting procedures.
• Includes study‑specific requirements on participants and vulnerable populations, informed consent, data protection, insurance and other core aspects of clinical research governance.
• Organises information into more than 750 searchable fields per country, allowing retrieval of detailed, standardised content tailored to study needs.

Search and comparison features

• Allows search by study type and country to obtain relevant national requirements for a given project.
• Offers a comparison function to review provisions side by side across two countries for the same study type, supporting the design and extension of multinational clinical studies.
• Provides filters, including for specific populations, where additional regulatory or ethical considerations apply.

Regulatory background and intended use

• Includes contextual information on key European clinical trial legislation and systems, such as a dedicated Clinical Trials Information System (CTIS) page describing the single entry point for clinical trial data in the European Union.
• Serves as an informational tool to facilitate compliance with national and European regulatory and ethical requirements when preparing and managing clinical studies; it does not replace legal advice or direct consultation with authorities.