PedCRIN developed a series of tools (WP3) and procedures to support the setup and the management of multinational neonatal and paediatric clinical trials in Europe. These tools are developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The removal of barriers to trial management will speed up the evaluation of new and improved therapies.
View this resource Bookmark this resourceClinical Trial Design
ICH Statistical Principles for clinical trials E9
Published by ECRINInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Clinical Trials ToolkitThis 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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Guideline for the Content of Statistical Analysis Plans in Clinical Trials
Published by Liverpool Clinical Trials Center (LCTC)ECRIN
Clinical Trials ToolkitA checklist of 32 minimum items for inclusion in SAPs that was developed with the primary intention of being applicable to the final analyses of later-phase randomized clinical trials addressing the minimum recommended content of a SAP
View this resource Bookmark this resourceSearch of metadata (including protocols and Statistical Analysis Plans) on published clinical trials.
View this resource Bookmark this resourceDatabase of publicly and privately funded clinical studies conducted around the world. The Study Documents tab allows search for SAP (Statistical Analysis Plan), protocols and Informed consents
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EMA list of national competent authorities in the EU
Published by European Medicines Agency (EMA)ECRIN
Clinical Trials ToolkitUpdated list of European national competent authorities and their contact details
View this resource Bookmark this resourceThe STARS (Strengthening Regulatory Science) project has developed an online Comprehensive Inventory that assists European academic drug developers in finding various support services provided by NCAs, public actors and private entities. The inventory lists various support services including assistance in clinical trial applications
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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
Clinical Trials Toolkit
The latest EU regulation for clinical trials on medicinal products for human use replaces national laws and describes the rules for assessing clinical trial applications and conducting clinical trials throughout the EU
View this resource Bookmark this resourceAn initiative of the Global Health Network, this Protocol Development Toolkit has been developed to support researchers in this process, to provide the tools and guidance to produce a high-quality health research Protocol.
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OECD Recommendation on governace of clinical trials
Published by ECRINOrganization for economic cooperation and development (OECD)
Clinical Trials ToolkitTo facilitate international co-operation in clinical trials on medicinal products, particularly for trials initiated by academic institutions, in December 2012 the OECD Council adopted a set of principles calling for improved consistency among national regulations and their interpretations, and on streamlined procedures for the oversight and management of clinical trials. This framework introduces a risk-based oversight and management methodology for clinical trials.
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