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 ApprovalIntroduction 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.
Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page.