Home | Introduction | Metadata | Application | Further reading | Landscape of resources |

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Welcome to FAIR4Clin - a guide for Clinical trial and healthare data. This work was done and is maintained as part of the FAIR implementation project - an initiative by the Pistoia Alliance, a not-for profit organization to facilitate pre competitive collaboration in life science industry. The FAIR4Clin guide consists of three parts: Introduction, Metadata and Application which can be explored below:

Introduction

• Challenges for Clinical data and why this guide will help
  • Who this guide is designed for
  • Context of this guide: Clinical Data Challenges and Opportunities
  • Purpose of this guide: From Awareness to Making Pragmatic Choices
  • Scope of this guide
  • Clinical study data can be big!
  • A multiplicity of clinical data types
• How the principles FAIR can bring value to Clinical data
  • Realising value for clinical trial data
  • Realising value from Real World Data

Metadata

• Clinical study design and FAIR implementation
• Clinical study data process through the FAIR lens
  • Planning and preparation of the study
  • Approvals, permissions and agreements
  • Study conduct and data collection
  • Data curation / harmonisation processes
  • Analysis of data
  • Reporting
  • Data follow-up activities
• Common Data Models for clinical data
  • CDISC
  • OHDSI
  • FHIR®
• Shared model of clinical study design and outcome
  • The BRIDG initiative
  • Semantic integration with Semantic Web standards

Application

• Clinical Trial Registries
  • Background
  • FAIR assessment of clinical trial registries
  • Clinical Real World Data
  • Other registries and efforts
• Quality and Governance of Clinical data
  • Quality of clinical data and metadata
  • Clinical data governance at the study level
• Infrastructure, training and culture for clinical FAIR data
  • Infrastructure
  • Education and training
  • Data-centric culture and the FAIR mindset

• Further reading

• Landscape of relevant Clinical and FAIR data resources

See the list of Contributors. Please use github to contribute to the guide, raise issues and contribute to the discussions!

FAIR4Clin is CC BY 4.0 Pistoia Alliance, Inc.