EU Clinical Trials Regulation (EU) No 536/2014 - Version 05 - Quick guide on rules and procedures

Sep 30, 2026

Quick guide for sponsors and investigators on the rules and procedures of the Clinical Trials Regulation (EU) No 536/2014, supporting practical implementation. Presents version 05 (published 01 March 2024) and clarifies objectives, scope, and the need to read alongside the legislative text. Covers key principles, transition period, pre-trial registration and submissions via CTIS (including IMPD-Q scenarios), validation and decisions, conduct-phase modifications and safety surveillance, post-trial notifications and archiving, transparency and data protection, CT-specific guidance, and references and annexes describing CTIS application composition.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages30

Reading Time1 h 16 min

AccessFree to download

Abbreviation list

1. Introduction

1.1 Some key principles of the CTR

1.2 Transition period of the Clinical Trials Regulation

2. Steps before the start of the clinical trial

2.1 User, product and organisation registration

2.2 Clinical trial application content and submission via CTIS

2.3 Validation, assessment and decision by Member States Concerned

3. Steps while the clinical trial is being conducted

3.1 Applications for substantial modifications and other modifications

3.2 Addition of MSC

3.3 Safety surveillance

3.4 Other necessary notifications for the sponsor

4. Steps once the CT has ended

4.1 Notifications by the sponsor via CTIS

4.2 Archiving

5. Transparency

5.1 Protection of commercially confidential information

5.2 Protection of personal data

6. CT specific information

6.1 Clinical Trials on Advanced Therapy IMP

6.2 Specific requirements for CT on IMP being a GMO

6.3 Other relevant guidances for CT

References

Annex 1. Composition of the clinical trial application in CTIS

March 2024, version 05 The rules governing medicinal products in the European Union VOLUME 10-Guidance documents applying to clinical trials Clinical Trials Regulation (EU) No 536/2014 in practice Quick guide on the rules and procedures ofthe EU Clinical Trials Regulation drawn up by the Clinical Trials Coordination and Advisory Group (CTAG) as its members are the National Contact Points defined in the abovementioned Regulation. | Document history: | | | --- | --- | | Date of discussion of draft by CTAG | Version 05 is adopted by written procedure by CTAG. | | Date of publication: | 01 March 2024 | | Supersedes: | 04 | | Changes compared to superseded version: | Annex I:
- Update in line with latest version on CTCG Best practice on naming of documents. | Important notice: The objective of this document is to provide sponsors and investigators a quick guide on the rules and procedures ofthe Clinical Trials Regulation (EU) No 536/2014 with a view to facilitating its implementation. This document should be read in combination with the legislative text. Ultimately, only the European Court of Justice can give an authoritative interpretation of Community law. More specific documents published on Eudralex 10: [https://health.ec.europa.eu/medicinal](https://health.ec.europa.eu/medicinal)products/eudralex/eudralex-volume-10_en TABLE OF CONTENT ABBREVATION LIST............................................................................................................................................................. 3 1. Introduction .................................................................................................................................................................. 4 1.1 Some key principles of the CTR ....................................................................................................................... 4 1.2 Transition period of the Clinical Trials Regulation ........................................................................................... 5 2. Steps before the start of the clinical trial .................................................................................................................... 5 2.1 User, product and organisation registration....................................................................................................... 6 2.2 Clinical trial application content and submission via CTIS............................................................................... 7 2.2.1 Submission of IMPD-Q in CTIS if sponsor is not allowed access to IMPD-Q.................................................8 2.2.2 Complex clinical trials and submission in CTIS ............................................................................................... 8 2.3 Validation, assessment and decision by Member States Concerned.................................................................. 9 3. Steps while the clinical trial is being conducted ...................................................................................................... 10 3.1 Applications for substantial modifications, non-substantial modifications per article 81.9 and other nonsubstantial modifications on the authorised clinical trial............................................................................................ 10 3.2 Addition of MSC ........................................................................................................................................... 11 3.2.1 Addition of MSC and IMPD-Q for decentral point of care............................................................................ 11 3.3 Safety surveillance ......................................................................................................................................... 12 3.4 Other necessary notifications for the sponsor ................................................................................................ 14 4. Steps o

FAQs

What is the purpose of this quick guide under the Clinical Trials Regulation (EU) No 536/2014?

It provides sponsors and investigators with a quick guide to the rules and procedures of the Clinical Trials Regulation to facilitate its implementation, and it should be read together with the legislative text.

What key activities are required before starting a clinical trial?

The guide covers registration (user, product, and organisation), preparation of clinical trial application content, and submission via CTIS, including validation, assessment, and decision by Member States Concerned.

How does the guide address changes during and after a clinical trial?

During the trial, it explains applications for substantial and other modifications, addition of MSC, safety surveillance, and sponsor notifications; after the trial ends, it describes sponsor notifications via CTIS and archiving.

Sep 30, 2026

Uploaded by Maya Linwood