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Guidance for good randomized trials (The Good Clinical Trials Collaborative)

The guidance is intended to support all individuals and organizations involved in the planning, conduct, analysis, oversight, interpretation, funding, and regulation of RCTs of any health intervention for any purpose in any setting.

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Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

Published by ECRIN European Medicines Agency (EMA)

Clinical Trials Toolkit

The EMA guideline on the content, management and archiving of the TMF provides guidance relating to the media used for storage of documents (including requirements when original records are transferred to electronic media for the purpose of archive).

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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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CONSORT statement

Published by ECRIN CONSORT

Clinical Trials Toolkit

CONSORT Statement is an evidence-based, minimum set of recommendations for reporting randomized trials. It offers a standard way for authors to prepare reports of trial findings

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CONSORT statement of N-of-1 trials (extension of the CONSORT statement)

Published by ECRIN CONSORT

Clinical Trials Toolkit

A CONSORT extension for N-of-1 trials that provides guidance on the reporting of individual and series of N-of-1 trials

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Research Data Management

Published by ECRIN University College London (UCL)

Clinical Trials Toolkit

A guide to managing outputs of research projects and handling issues such as copyright and data protection laws

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Research Data Management Kit

Published by ECRIN ELIXIR

Clinical Trials Toolkit

This is a web-based resource for research data management, . It has been designed to guide life scientists in their efforts to better manage their research data following the FAIR Principles as well as help researchers be more productive for themselves and their collaborators.

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Data Certification Standards/Data Certified Units

Published by ECRIN

Clinical Trials Toolkit

The ECRIN Data Centre Certification programme identifies non-commercial clinical trials units (CTUs) in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data.

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EDCTP Data Management portal

Published by ECRIN The Global Health Network

Clinical Trials Toolkit

An initiative of the Global Health Network. This tool helps to identify the areas to consider when developing a Data Management Plan, with a particular focus on data management systems and how to organise and structure data. Includes best practices for data capture, entry, processing and monitoring and how to prepare your data for analysis, sharing and archiving.

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EDCTP Data Sharing Toolkit

Published by The Global Health Network ECRIN

Clinical Trials Toolkit

An initiative of the Global Health Network, this Data Sharing Toolkit, collates practical information and resources related to data sharing, including data management basics, data sharing steps and a repository finder

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Guidance for good randomized trials (The Good Clinical Trials Collaborative)

Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

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

CONSORT statement

CONSORT statement of N-of-1 trials (extension of the CONSORT statement)

Research Data Management

Research Data Management Kit

Data Certification Standards/Data Certified Units

EDCTP Data Management portal

EDCTP Data Sharing Toolkit

IMT Cookie Overview