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SPIRIT PRO Extension for inclusion of patient-reported outcomes in clinical trials protocols

Published by ECRIN

PCOMClinical Trials Toolkit

Extension of the SPIRIT (Standard protocol items: recommendations for interventional trials) guideline, SPIRIT PRO provides guidelines for inclusion of patient-reported outcomes in clinical trial protocols.

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PROMs Repository

Published by ECRINERICA

Clinical Trials ToolkitPCOM

The ERICA Patient Reported Outcome Measures (PROMs) Repository is the first attempt to identify and centralize Clinical Assessment Outcomes questionnaires of relevance for rare diseases and constitutes a milestone in the Europe-wide standardization of Patient-Centered Outcome Measures (PCOMs) and PROMs for rare diseases.

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PANDA: A practical Adaptive & Novel Designs and Analysis toolkit

Published by PANDAECRIN

ToolboxClinical Trials Toolkit

PANDA is aimed at trialists and researchers in clinical trials who are keen to learn about adaptive designs, their practical application, potential benefits and limitations. The target audience includes, but is not limited to, trial statisticians, clinicians, health economists, grant proposal developers, trial managers, data managers, and reviewers of grant applications

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The toolkit is a curated series of publicly accessible videos and links covering essential operational details that early investigators need to know before embarking on a clinical trial with a special focus on pediatric trials. Topics address study startup, study documents, consent, oversight, management, and safety.  

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A target product profile (TPP) outlines the desired characteristics of a new drug or other medical intervention (e.g diagnostic tool). TPPs describe intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. In industry TPPs are used as planning tools that guide development towards desired characteristics. In the regulatory context, TPPs are considered as tools to frame development in relation to submission of product dossiers.

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