UK Local Information Pack webinar
Friday 10 May
If you can not hear us speaking / background
music, you will need to also dial in via a phone:
0207 4849 444 PIN code: 93916827#
Four Nations
NHS/HSC
Compatibility
Programme
UK Local
Information Pack
Webinar
Four Nations Programme Aims
• Continue to streamline processes
• Maintain compatible systems across the UK
• Support cross border research
• Make it easier to do research across the UK
Introduction of a UK Local Information
Pack
• Implementation outside IRAS on 5 June 2019
• A consistent set of documents for study set up across
England, Northern Ireland, Scotland and Wales
• Part of the Local Information Pack is an Organisation
Information Document, this replaces:
– Statement of Activities in England and Wales
– Site Specific Information Form in Northern Ireland and Scotland
Site Specific
Information
submission in
Northern Ireland
and Scotland
Local Information
Pack
Covering
template email
Localised
Organisation
Information
Document /
Delegation Log
Statement of
Activities in
England and Wales
What makes up the Local Information
Pack?
IRAS Form Submission
IRAS Form /
Documents as
part of IRAS
submission
Local Information Pack Contents
Outline
Organisation
Information
Document
Commercial studies
Covering email in standard template format
IRAS Form
Protocol
Patient information sheet and consent form
Localised Organisational Information Document (commercial)
Model Clinical Trial Agreement
Industry Costing Template or Tool
Other documents to help support study set up
For England and Wales
– HRA and HCRW Initial Assessment Letter/or Approval letter
What makes up the Local Information
Pack?
Non
-commercial studies
Covering email in standard template format
IRAS Form
Protocol
Patient information sheet and consent form
Localised Organisational Information Document (non
-commercial)
IRAS Schedule of Events or SOECAT
Model Non
-commercial Agreement, if being used as agreement
Other documents to help support study set up
For England and Wales
– HRA and HCRW Initial Assessment Letter/or Approval letter
What makes up the Local Information
Pack?
Participating Identification Centres
• PICs do not require a Local Information Pack
• Use of Model PIC agreements as subcontract
– Subcontract between participating NHS/HSC organisation and
PIC
– Sets out agreed arrangements
– Includes data processing agreement for GDPR
– Commercial and non-commercial versions available
Organisation Information Document
• An Organisation Information Document provides
information to the participating NHS/HSC organisation(s)
to support the set up of research
• There are commercial and non-commercial versions
– In IRAS Help
– For non interventional, non commercial studies can be used as
an agreement
Changes to IRAS Form Submission
• An outline Organisation Information Document is part of
the IRAS Form submission
– Document is partially completed by Sponsor at IRAS submission
• IRAS Schedule of Events/Schedule of Events Cost
Attribution Template (SoECAT)
– For non-commercial studies
– A change for Northern Ireland and Scotland (new)
– Guidance is available in IRAS help
Localised Organisation Information
Document
• The outline Organisation Information Document is
localised for each participating site (Sponsor)
– Complete information that is known
– May only be partially complete at this point
– Will vary for different studies
Sharing the Local Information Pack
• For sites in England, Northern Ireland and Wales
– Sponsor emails the Local Information Packs to each participating
NHS/HSC organisation
• For sites in Scotland
– Sponsor emails the Localised Organisation Information
Documents and Delegation Logs to NRS coordinating function in
who make available to participating NHS organisations.
• Complete the appropriate email template
– Multiple templates will be required for cross border studies
Concluding the process
• Sponsor agrees and finalises the localised Organisation
Information Document with PI, local research team,
networks/specialty groups AND R&D at the same time
– In England, Northern Ireland and Wales NHS/HSC provides
confirmation of capacity and capability using a model agreement
or the Localised Organisation Information Document according to
study type
– In Scotland NHS provides NHS permission
Starting the study
• England, Northern Ireland and Wales
– Confirmation of capacity and capability means that the
organisation will take part and is ready to do so when the
sponsor says start. For CTIMPs this will be after Site Initiation
Visit etc.
• Scotland
– When the NHS study delivery team is ready to start they do so.
For CTIMPs this will be after Site Initiation Visit etc.
Local Information Pack – England/Wales
Sponsor or delegate
(Applicant)
Central Booking Service
(CBS)
Approval Officer/
Approval Admin
Approval Specialist
Prepare submission as usual
in IRAS
Participating NHS
Organisation
Change: Outline
Organisational Information
Document
CBS book to REC or for study
wide review for non-REC
studies
Submit in IRAS
Undertake Initial
Assessment
Issue Initial Assessment
letter and Initial assessment
information for REC
Change: localised
Organisational Information
Document and template
email
Change: Organisational
Information Document
Validation
Local Information Pack – NI
Sponsor or delegate
(Applicant)
Central Booking Service
(CBS)
Research Ethics
Committee (REC)
Coordinating Function
Prepare submission as usual
in IRAS
Participating HSC
Organisation
Change: Outline OID(s)
drafted according to
activities
CBS book to REC or for study
wide review for non-REC
studies
Submit in IRAS
Change: Import into HARP
and validate for REC studies
Change: Validate only for
Non-REC studies
Download from HARP and
upload to EDGE and follow
existing processes
Change: Produce localised
OID(s) and Delegation Log(s)
depending on Site Type(s)
and email the LIP to
organisations using
template email
Change: Access pack
Local Information Pack – Scotland
Sponsor or delegate
(Applicant)
Central Booking Service
(CBS)
Research Ethics
Committee (REC)
Coordinating Function
Prepare submission as usual
in IRAS
Participating NHS
Organisation
Change: Outline OID(s)
drafted according to
activities, IRAS Schedule of
Events/SoECAT required for
non-commercial studies
CBS book to REC or for study
wide review for non-REC
studies
Submit in IRAS
Import into HARP and
follow existing processes
Validate and confirm full
document set
(IRAS checklist to be
updated)
Download from HARP and
upload to SReDA and follow
existing processes
Change: Produce localised
OID(s) and Delegation Log(s)
depending on Site Type(s)
and email to NRS PCC using
template email
Change: Upload to SReDA
and share OID(s) and
Delegation Log(s) with Sites
(R&D and
Network/Specialty Group)
using template email
Change: Access via SReDA
and share with Research
Team (PI) to finalise
alongside the Sponsor
Role of the Sponsor – Summary
• Complete Local Information Pack documentation
• Distribute Local Information Packs to all sites in England,
Northern Ireland and Wales
• Send localised Organisation Information Documents and
Delegation Logs to coordinating function in Scotland
• Finalise localised Organisation Information Document in
a facilitative manner
