European Medicines Agency (EMA)

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

Published by European Medicines Agency (EMA)ECRIN

Clinical Trials Toolkit

The guideline is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs). The document includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and on the conduct of FIH/early CTs

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European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance

Published by European Medicines Agency (EMA)ECRIN

Clinical Trials Toolkit

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request. This guidance document also explains the scope and nature of scientific advice and protocol assistance. It will enable Applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently.

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EMA Guideline on clinical trials in small populations

Published by European Medicines Agency (EMA)ECRIN

Clinical Trials Toolkit

This Guideline considers problems associated with clinical trials when there are limited numbers of patients available to study. It has been prepared by the CHMP (Committee for Medicinal Products for Human Use) Efficacy Working Party in joint collaboration with members of the Scientific Advice Working Party (SAWP), the Committee on Orphan Medicinal Products (COMP) and the Paediatric Expert Group (PEG).

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European Medicines Agency. ICH Topic E15. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (EMEA/CHMP/ICH/437986/2006). 2007.

Published by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Sample CodingEMAGuidelinePharmacogenomicsGenomic Data

This guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories. 

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