The International Compilation of Human Research Standards is a global reference, developed by US Department of Health and Human Services, that lists over 1,000 laws, regulations and guidelines (“standards”) protecting research participants in more than 130 countries, plus standards from international and regional organisations. It is organised by world region (including a dedicated Europe section) and, within each country or organisation, classifies information into nine categories: general human subjects research; drugs, biologics and devices; clinical trial registries; research injury; social‑behavioural research; privacy and data protection; human biological materials; genetic research; and embryos, stem cells and cloning. For each category it distinguishes key organisations from relevant standards and, wherever possible, provides web links to the source documents, many available in English or translatable online. First published in 2005, the Compilation focuses specifically on human research protections and is intended for researchers, research ethics committees, sponsors and others overseeing research involving human participants.The website has many more resources that can be interesting for IRB and research community including trainings.

This document from the Clinical Trials Coordination Group (CTCG) summarises national fees for clinical trials submitted under the Clinical Trials Regulation in the Clinical Trials Information System (CTIS) for all European Union and European Economic Area member states (a total of 29 countries).  This resource helps sponsors of investigator‑initiated trials to anticipate national costs and plan budgets for multi‑country submissions under the Clinical Trials Regulation. It lists, for each country, the website where official fee information can be found, the type of proof of payment required in CTIS, the expected timing of fee payment in relation to validation and assessment, and whether fee reductions are available for non‑commercial sponsors, low‑interventional trials, lapsed applications, withdrawn applications or other specific situations. The table highlights, for example, countries with zero fees for non‑commercial sponsors, reduced fees or no fees at all.

EUREC (European Network of Research Ethics Committees) is a pan-European umbrella network connecting national Research Ethics Committee (REC) associations and research ethics experts across Europe. Founded in 2005, it provides country-specific information on REC systems, resources for REC members, and supports capacity building. For investigators, it is the key reference for identifying the ethical review framework and relevant committees in each participating European country.

The European Medicines Agency maintains an online list of national competent authorities responsible for human medicines in each European Union and European Economic Area Member State. The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not fall under the scope of the centralised procedure. This directory is part of the European medicines regulatory network information and is regularly updated. Investigators and sponsors planning clinical trials or other regulatory activities in one or more European countries can use it to quickly identify and contact the relevant national competent authority for clinical trial authorisations and other regulatory queries.
 

The Regulatory and Ethical Database (RED) is a regularly updated, online search tool that provides country‑specific information on regulatory and ethical requirements for clinical research across Europe. Developed by the European Clinical Research Infrastructure Network (ECRIN), it offers structured, up‑to‑date content on national legislation, competent authorities, ethics committees and study‑specific provisions for medicinal products, medical devices and other clinical studies. RED is designed to support investigators and sponsors in planning, initiating and conducting mono‑ and multinational clinical studies by providing simple, centralised access to key submission and compliance information by country and study type. It also provides regulatory and ethical information for specific population groups, such as minors, incapacitated persons, emergency situations and pregnant or breastfeeding women. For researchers looking to expand a study to another country, a “Compare” feature enables side‑by‑side review of legislation and other requirements for clinical research in two selected countries.

This MedEthicsEU overview, written and endorsed by a group of national representatives of Medical Research Ethics Committees in EU/EEA member states, summarises Part II clinical trial application requirements per country under the Clinical Trials Regulation (EU) No 536/2014. Version 3.0 (14 March 2025) covers 21 member states and supersedes version 2.0. It is a practical European reference for sponsors compiling country‑specific Part II documentation for multi‑country clinical trial applications in CTIS. For each country it lists, for every Clinical Trials Information System Part II placeholder, which documents are required, whether European Commission or national templates are mandatory or recommended, the legal basis (Regulation, national law, guidelines or other) and links to ethics committee or authority websites. The document is described as a living, non‑binding tool to facilitate submission of clinical trial applications and should be read together with the Clinical Trials Regulation and EudraLex Volume 10 templates.

This EudraLex Volume 10 page, published by the European Commission, provides the official clinical trial application templates for preparation of Part I and Part II documentation for the Clinical Trials Information System (CTIS) under Regulation (EU) No 536/2014 in European Union and European Economic Area member states. It includes document templates for the CTIS form section (statement on compliance with Regulation (EU) 2016/679 on data protection) and Part II application documents, such as compensation for trial participants, investigator curriculum vitae, declaration of interest, site suitability form, informed consent and patient recruitment procedure, and compliance with rules for biological samples. Templates are available in portable 
document format (PDF) and Word format for direct use or adaptation by sponsors.

Clinical Trials Regulation (EU) No 536/2014 in practice” is a quick guide produced under EudraLex Volume 10 to help sponsors to apply the Clinical Trials Regulation (EU) No 536/2014 in the European Union and European Economic Area. Prepared by the Clinical Trials Coordination and Advisory Group (CTAG), whose members are the National Contact Points named in the Regulation, it provides a practical overview of the main rules and procedures, to be read alongside the legislative text. The guide outlines key principles of the Clinical Trials Regulation, the transition period and step‑by‑step processes before, during and after a clinical trial, including use of the Clinical Trials Information System (CTIS), safety reporting, transparency, and specific requirements for advanced therapy and genetically modified investigational medicinal products. It is intended to facilitate day‑to‑day implementation of the Regulation for national and multinational clinical trials.

Regulation (EU) No 536/2014 is the core European legislative act governing clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC and sets directly applicable, uniform rules for the authorisation, conduct and supervision of clinical trials in all Member States, with specific provisions on low‑intervention clinical trials. It is the primary legal reference for sponsors and investigators planning or conducting clinical trials with medicinal products in Europe.The Regulation aims to ensure that the rights, safety, dignity and well‑being of trial subjects are protected and that data generated in clinical trials are reliable and robust, while enabling efficient authorisation procedures, including for multinational trials.