The UK Local Information Pack launches tomorrow.
Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from one consistent package to support study set-up and delivery across the UK.
From 5 June, the Statement
of Activities used in England and Wales for non-commercial studies and the Site
Specific Information form, used in Northern Ireland and Scotland is being
replaced with a UK wide Organisational Information document.
Commercial and Non-commercial versions of the Organisation Information document templates and associated guidance are available in IRAS Help. For non-commercial, studies that are not clinical trials or clinical investigations, the Organisation Information document should also be used as the agreement between sponsor and participating NHS/HSC organisation.
Mary Cubitt, Programme Implementation Manager – Four Nations Nations NHS/HSC Compatibility and HRA Approval
Introduction of a consistent set of documents to support study set up across the UK streamlines the set-up of research and makes it easier for research to undertake cross boarder research, enabling research to be more accessible to participants.
The Organisational Information document, in outline format, will be a component of the IRAS form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research.
To support sharing of the UK Local Information Pack with NHS/HSC organisations, a series of standard template emails have been developed, following feedback from the community. These are a key feature to ensure a complete pack is share with the participating organisation, and provided to the right contacts within the organisation.