UK Local Information Pack - Update for Commercial Sponsors and Contract Research Organisations (CRO)
A UK Local Information Pack will be introduced on Wednesday 5 June 2019. From this date the Organisational Information Document will be required as part of the UK Local Information Pack, to be shared by commercial and non-commercial sponsors when setting up NHS/Health and Social Care participating organisations in the UK. More information is given in the IRAS Help Site Specific section.
The UK Local Information Pack is the set of documents that NHS / Health and Social Care organisations use to formally start preparing to deliver the study. A key feature of the UK Local Information Pack is the Organisation Information Document.
The Organisation Information Document will replace the NHS / Health and Social Care Site Specific Information Form currently used in Northern Ireland and Scotland. For commercially sponsored studies, the commercial Organisation Information Document is a short cover document that standardises the information previously provided by sponsors to participating organisations as part of the Local Information Pack in England and Wales.
In outline format the Organisational Information Document 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. Organisation Information Document templates and associated guidance are available in IRAS Help.
The adoption of the UK Local Information Pack will benefit set up of commercial studies in the NHS/Health and Social Care by
a) Providing a consistent set of documents for sponsors to share documents with sites when undertaking cross border studies across England, Northern Ireland, Scotland and Wales.
b) Eliminating the need for an NHS / Health and Social Care SSI form when using NHS/Health and Social Care participating organisations in Northern Ireland or Scotland
c) Giving the sponsor control of the timing of sharing the Local Information Pack with participating NHS/Health and Social Care organisations across the whole of the UK as is already the case for participating organisations in England and Wales.
d) Creating a clear time point across the whole of the UK for the formal request to the participating NHS/Health and Social Care organisation to begin arranging set-up.
The UK Local Information Pack is a development of the Local Information Pack used in England since 2016 and in Wales from 2018, based on feedback from sponsors and NHS organisations.
Email templates have been developed setting out the full checklist of documents to be provided as part of the formal provision of the Local Information Pack to each participating organisation, and the relevant recipients in each nation.
Non NHS / Health and Social Care SSI Forms are also being replaced by specific non-NHS /Health and Social Care arrangements. More information will be issued about this soon.
Guidance for sponsors on the use of the UK Local Information Pack, the template emails and the template Organisation Information Document are available in IRAS Help for commercial organisations to begin to prepare for implementation on 5 June 2019. Information about transitional arrangements are provided.
Updates and questions and answers are provided on the Four Nations Compatibility webpage.
Information for researchers and NHS / Health and Social Care organisations on the update can be found here.