CTR & CTIS: Quick Guide for Sponsors

A quick guide on the main rules and procedures of the Clinical Trials Regulation (CTR) has been released for sponsors who wish to conduct clinical trials in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region. It is recommended to read the CTR Questions and answers document first. In addition, additional documents (guidelines, guidances, recommendation papers, Q&As) to be considered are provided in the document.

Introduction

A clinical trial (CT) may only be conducted if:

• The rights, safety, dignity and well-being of participants are protected and prevail over all other interests,
• It is designed to generate reliable and robust data.

The CT design and conduct should comply with the CTR and the General Data Protection Regulation (GDPR) together with the complementary national legislation. The following GxP guidelines do also apply:

• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for Investigational Medicinal Product (IMP) manufacture and distribution;
• Good Clinical Practice (GCP) for conducting the CT. In case the provisions of CTR and the ICH GCP guidelines differ, the rules defined in the CTR prevail.

Quick Guide Content

The guide contains the following specific topics:

• Key principles of the CTR
• Transition period of the CTR
• Steps before the start of the CT
• Steps while the CT is being conducted
• Steps once the CT has ended
• Transparency
• CT specific information
• Annex 1: Composition of the CT application in CTIS (e.g., Protocol, IB, GMP compliance, IMPD, Labelling, Compliance with national requirements on data protection) 
• Annex 2: Calendar for the initial authorization of a CT (each phase - validation, assessment and decision - has its own maximum timelines for both MSCs and Sponsors)
• Annex 3: Overview of mandatory notifications by the Sponsor through the CTIS after the trial has been authorized

In addition, an Abbreviation List and a List of References (with links to guidelines, guidances, recommendation papers, etc.) are provided.

More information is available in the Quick guide for sponsors - Regulation 536/2014 in practice published in Eudralex vol. 10 and in the one-pager quickguide for sponsors on getting started with CTIS published in Clinical Trials Information System: training and support.