Sharing UK Local Information Pack with NHS/HSC Organisations
This presentation provides an overview of sharing the UK Local Information Pack with NHS/HSC organizations, including its purpose, how to share it, and the components of non-commercial and commercial packs. The pack aims to facilitate research studies by maintaining compatible systems across the UK, supporting cross-border research, and simplifying research processes. Guidance on sharing the pack, version control, and using standard templates is highlighted for efficient communication and collaboration.
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Presentation Transcript
NHS/HSC Site set-up - Sharing UK Local Information Pack
This bite size presentation provides a high level overview on sharing the UK Local Information Pack with NHS/HSC organisations. It should be read in conjunction with the full guidance available in IRAS
Purpose of the UK Local Information Pack? The purpose of the UK Local Information Pack is to provide a clear and consistent set of documents to support NHS/ HSC organisations set up research studies This; Maintains compatible systems across the UK Supports cross border research Makes it easier to do research across the UK
How to share the Local Information Pack Complete version control table Attach all documents as per email Send to recipients as indicated in nation specific template email Use nation specific template email from IRAS
How to share the Local Information Pack Use standard template email All are available in IRAS Nation specific templates Non commercial and commercial templates Ensure you complete table in nation specific template email with version and dates of documents to be attached Attach required documents as per nation specific email (ensuring these match the versions listed in the email)
What makes up a non-Commercial UK Local Information Pack? Non Commercial Studies Covering email in standard template format Model Agreement if applicable IRAS Form IRAS Schedule of Events or SOECAT Protocol Delegation Log (Required for all interventional studies with a principal investigator. Indicate if this is being provided at a later date) Patient information sheet and consent form For England and Wales - Pharmacy Technical Review Form (for Pharmacy Assurance) and/or Research Exposure Form (for Radiation Assurance) Localised Organisation Information Document (non-commercial) For England and Wales Initial Assessment Letter /or Approval letter
What makes up a Commercial UK Local Information Pack? Commercial Studies Covering email in standard template format Model Clinical Trial Agreement IRAS Form Industry Costing Template or Tool Protocol Delegation Log (Required for all interventional studies with a principal investigator.) Patient information sheet and consent form For England and Wales - Pharmacy Technical Review Form (for Pharmacy Assurance) and/or Research Exposure Form (for Radiation Assurance) Localised Organisation Information Document (commercial) For England and Wales Initial Assessment Letter/or Approval letter
When to share the Local Information Pack After initial discussion with sites expression of interest, feasibility After IRAS submission and validation by lead nation or Initial Assessment for England and Wales
Who to share pack with (England, Wales and Northern Ireland) Delivery team R&D England only
Who to share pack with (Scotland) nhsg.nrspcc@nhs.net Localised Organisation Information Document NRSPCC make documents available to NHS sites in Scotland Delegation Log
What happens next? Agree costings and contracts Sponsor and site complete Organisation Information Document Site confirms capacity and capability through exchange of agreement (England Wales and Northern Ireland) NHS permission (Scotland)
FURTHER GUIDANCE: IRAS 4 Nation Programme
