To support the implementation of the FAIR guiding principles for the data management cycle by Life Science industry, through sharing best practices through provision of a FAIR Toolkit and support for clinical trials FAIR data management.

Project deliverables

A major deliverable from this project is the release of a freely accessible toolkit to help life science companies to implement the FAIR (Findable, Accessible, Interoperable, Reusable) guiding principles for data management and stewardship (DOI:10.1038/sdata.2016.18). Future work will maintain the toolkit and apply it to clinical trial FAIR data management for a perticular use case.

Why is this important?

As the life sciences industry continues to transform digitally, the sector needs clear and practical guidance on how data and relevant metadata is captured and managed to foster greater collaboration and more effective partnerships. The FAIR guiding principles help to meet this need, but many companies struggle to implement the guiding principles as discussed by Wise and co-authors (DOI:10.1016/j.drudis.2019.01.008). This practical need has been addressed by the development of the FAIR Toolkit which consists of relevant use cases and method tools, training and change management. It will be important to maintain the FAIR Toolkit and to demontrate it’s value to clinical trial data management.

What will the project achieve?

The FAIR Toolkit includes use cases and methods designed to support the implementation of FAIR data management by life science industry. The methods include tools, training and change management which are illustrated by relevant use cases cases. The toolkit is designed and built to be a user-friendly and freely accessible web site which will be maintainedby updating existing content and adding new content. Future plans also include demonstration of practical benefits of the toolkit methods for management of clinical trial data throughout the different phases of research and development.

How will the project do this?

The project team collected candidate content in a simple wiki and selected the most relevant content to support implementation of FAIR by scientists in life science industry. This enabled the specification, design and development of a FAIR Toolkit web site serving as a “one-stop shop” to start the journey to support the FAIR data management life cycle. The Pistoia FAIR Toolkit can be accessed at fairtoolkit.pistoiaalliance.org which was developed with referenced to the sister Pistoia UXLS Toolkit: uxls.org. Next, we are turning our attention to the application of the toolkit methods to clinical trial FAIR data management. This will be driven by a use case which involves two co-morbid disease indications, type 2 diabetes and breast cancer.