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Guideline for the Content of Statistical Analysis Plans in Clinical Trials

Published by Liverpool Clinical Trials Center (LCTC)ECRIN

A 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

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ECRIN Metadata Repository

Published by ECRIN

Clinical Trials Toolkit

Search of metadata (including protocols and Statistical Analysis Plans) on published clinical trials.

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Clinical Trials Registry (NIH)

Published by NIH ECRIN

Clinical Trials Toolkit

Database 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 Toolkit

Updated list of European national competent authorities and their contact details

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Comprehensive Inventory STARS

Published by ECRIN STARS

Clinical Trials Toolkit

The 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

Published by ECRIN EU

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

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ICH Topic E2A: Clinical Safety Data Management

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

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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Safety training

Published by Swiss clinical trial organisation (SCTO)ECRIN

Clinical Trials Toolkit

Swiss Clinical Trial Organisation Tools: Safety training to consolidate investigator´s knowledge of patient safety and reporting issues in clinical research

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Introduction to collecting and reporting adverse events

Published by ECRIN The Global Health Network

Clinical Trials Toolkit

This short course provides a general introduction and overview of Adverse Events and how to deal with them when they occur. This course is suitable for everyone involved in clinical research.

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Guideline for the Content of Statistical Analysis Plans in Clinical Trials

ECRIN Metadata Repository

Clinical Trials Registry (NIH)

EMA list of national competent authorities in the EU

Comprehensive Inventory STARS

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

ICH Topic E2A: Clinical Safety Data Management

ICH Topic E2F Development Safety Update Report

Safety training

Introduction to collecting and reporting adverse events

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