How to use this toolbox? Era4Health

The ERA4Health Clinical Trials Toolbox brings together practical resources to support researchers, study teams and stakeholders in the planning, designing, conducting and reporting of clinical trials.

Rather than serving as a database of resources, the Toolbox classifies and structures relevant tools, guidance, templates, checklists and recommendations according to the activities and processes involved in setting up and conducting a clinical trial.

The Objective

The Toolbox aims to make relevant and reliable resources easier to find, understand and use.

It provides a structured way to navigate the methodological, ethical, regulatory and operational aspects of clinical trials, bringing together resources that may otherwise be spread across different organisations, disciplines and platforms.

How to use the Toolbox

You canuse the Toolbox at any stage of the clinical trial pathway. You can browse the pathway to explore resources by topic, or search directly using keywords and filters to find resources for a specific question or task.

  1. Identify your needs 
    Start with the question, activity or challenge you want  to explore.
  2. Browse the relevant section 
    Navigate through the pathway and select the domain, section or subsection that best matches your needs. There is no required order.
  3. Explore the resources 
    Each resource includes a short explanation of its relevance to the corresponding section or subsection.  
  4. Select what is relevant  
    Consider whether the resource is relevant  for your study and research context.
  5. Consult the original source 
    Follow the link provided to access the full resource and, where applicable, check that you are using the most recent version of the selected resource.
Domains, sections and subsections

The Toolbox is organised around five main stages of a clinical trial pathway:

  • Research question
  • Planning
  • Execution
  • Analysis
  • End of the trial

Within these five domains, sections and subsections cover key activities and topics that need to be considered throughout the clinical trial lifecycle.

Each subsection provides a brief overview of the topic and links to relevant resources.  

The Toolbox will be updated and expanded as new resources, research practices, and standards emerge.

You can also use the Search tab to find resources by keywords or  filter them by domain and sections.  

Scope and selection criteria

Included resources  have been selected according to the following criteria:

  • Publicly available – resources developed by research projects and relevant clinical research stakeholders, such as research infrastructures, universities and patient organisations.
  • Peer-reviewed – relevant research published in scientific journals.
  • Practical – applicable to one or more activities in the clinical trial pathway.
  • Applicable in Europe –relevant to clinical research conducted in Europe, including international resources  applicable to European context..
  • Sustainable – supported by  an identified team or organisation responsible for their development and/or maintenance.

National, regional or institutional resources specific to a single disease, as well as commercial resources, are outside the scope of the Toolbox.  

The Toolbox focuses on clinical trials of medicinal products for human use within the European regulatory context.