ICH E3 guideline on Structure and Content of Clinical Study Reports (ICH E3)

Published by ECRIN International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Clinical Trials Toolkit

The objective of this guideline is to allow the compilation of a single core clinical study report (CSR) acceptable to all regulatory authorities of the ICH regions

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ICH Statistical Principles for clinical trials E9

Published by ECRIN International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Clinical Trials Toolkit

This guidance is intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.

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ICH Topic E2A: Clinical Safety Data Management

Published by ECRIN International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Clinical Trials Toolkit

Notes for definitions and standards on Safety reporting for ICH topic E A 2

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ICH Topic E2F Development Safety Update Report

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

Guidance on Safety Reporting. The Development Safety Update Report (DSUR) proposed in this guideline is intended to be the common standard for annual clinical trial safty reporting among the ICH regions

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ICH General considerations for clinical studies E8

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

Describes internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medical products

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ICH General principles for planning and design of multi-regional clinical trials

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

Describes general principals for the planning and design of randomised multinational clinical trials with the aim of increasing its acceptability in global regulatory submissions

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ICH Clinical investigation of medicinal products in the paediatric population E11 (R1)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

Provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population. The purpose of this addendum is to complement, provide clarification and current regulatory perspective on topics in pediatric drug development.

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