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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998

Published by European Medicines Agency (EMA)

Animal Models Clinical Trials EMA Guideline Pharmaceuticals Toxicity Vaccine

This guideline applies to all pharmaceuticals, including biopharmaceuticals, vaccines (and their novel constitutive ingredients) for infectious diseases, and novel excipients that are part of the final pharmaceutical product.

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Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

Published by EC

Adolescent Assent Clinical Trials Consent Ethics Committee Minor Neonate

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

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NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

Published by NIH

Clinical Trials Rare diseases Small Business Innovation Research

The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies.

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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

Published by EC

Clinical Trials Medicinal Products

EU Regulation

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In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials

Published by Nature Communications

Clinical Trials In silico virtual patients

In-silico trials rely on virtual populations and interventions simulated using patient-specific model and may offer a solution to lower these costs. In this article, It is presented the flow diverter performance assessment (FD-PASS) in-silico trial, which model the treatment of intracranial aneurysms in 164 virtual patients with 82 distinct anatomies with a flow-diverting stent, using computational fluid dynamics to quantify post-treatment flow reduction

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European Commission. Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified. Version 5. November 2021

Published by European Commission (EC)

Clinical Trials GMO Good Practice Translational Research

Guideline on Clinical trials with medicinal products that contain or consist of GMOs must also comply with applicable requirements under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

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Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol

Published by EMA

assessment clinical trial participants Clinical Trials compliance protocol Regulation (EU) No 536/2014 Serious Breaches service provider Sponsors

This document describes the guideline for the notification of serious breaches of
Regulation (EU) No 536/2014

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Good Lay Summary Practice

Published by European Commission (EC)

Clinical Trials Good Practice

This guidance was developed in cooperation with the Roadmap Initiative to Good Lay
Summary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group of
the European Commission representing Ethics Committees and National Competent
Authorities (NCA)).

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Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Published by European Medicines Agency

Clinical Trials Medicines Paediatrics

This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be
prepared.

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Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.

Published by European Medicines Agency

Adverse Effects Clinical Trials Neonate

This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998

Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials

European Commission. Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified. Version 5. November 2021

Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol

Good Lay Summary Practice

Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.