Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMEA/CHMP/SWP/28367/07 Rev. 1
Effective from01/02/2018
KeywordsFirst-in-human, phase I, early clinical trials, investigational medicinal product, risk mitigation, integrated protocols, multiple ascending dose, dose escalation

This document addresses non-clinical and clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of early clinical trials, including trials with integrated protocols. Emphasis is put on defining the uncertainty associated with the medicine tested at each step of the development and describing how the potential risks that might arise from this uncertainty will be addressed. The revision was made in cooperation with the EU Clinical Trials Facilitation Group (CTFG).

Document history

Revision 1

Current version

Adopted guideline

PDF iconOverview of comments

Draft guideline

PDF iconConcept paper

PDF iconOverview of comments

In operation: 01/02/2018-present

Published: 27/09/2017

Published: 15/11/2016

Published: 21/07/2016

Published: 27/09/2017

First version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/09/2007-01/02/2018

Published: 03/05/2007

Published: 22/03/2007

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