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Four Nations NHS/HSC Compatibility Programme - Project Updates

The four UK nations are committed to making it easier to carry out research in the UK. The aim is to make the researcher experience of study set up the same across the UK. Working together, England, Northern Ireland, Scotland and Wales are developing compatible cross-border processes.

If you have any queries about the programme, please contact the operational lead for your nation.

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LATEST UPDATE

19/06/2019 - Updates following implementation of the UK Local Information Pack

Participant Identification Centres

Model Participant Identification Centre (PIC) agreements have now been published and are available on IRAS Help alongside guidance.

PICs are NHS/HSC organisations that identify potential research participants.  They are not research sites and should not be treated in the same way as research sites.

What contracting arrangements should be put in place with NHS/HSC PICs?

NHS/HSC PICs should be set up by through a sub-contracting arrangement with the participating NHS/HSC organisation that the PIC supports using the appropriate model agreement:

Non-commercial Organisation Information Document Revision

Following the implementation of the UK Local Information Pack on 5 June 2019 the non-commercial Organisation Information Document has been updated to correct internal clause referencing, this is now available on IRAS Help.

When initiating a new study always use the latest revision of the Organisation Information Document in IRAS.

For studies already in progress when a revision is made to the Organisation Information Document template you can continue to use the outline Organisational Information Document originally submitted, there is no need to resubmit.

05/06/2019: Implementation of the UK Local Information Pack

Setting up NHS/HSC research in the UK: Implementation of the UK Local Information Pack

From today researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

The UK Local Information Pack contains an Organisation Information Document which has replaced the Statement of Activities that was used in England and Wales and the Site Specific Information form, which was used in Northern Ireland and Scotland.  The Organisational Information Document is required as part of the UK Local Information Pack for commercial and non-commercial research.

Examples of completed Schedule of Events Cost Attribution Template and Organisation Information Document templates are also now available on the Four Nations NHS/HSC Compatibility website on the UK Local Information Pack: Questions and Answers page. 

For more information and guidance on the UK Local Information Pack please visit IRAS Help.

The UK Local Information Pack, including the Organisational Information Document, should not be used for Participant Identification Centres (PICs).  Model PIC Agreements, to be used as a subcontract between participating NHS/HSC host organisations and PICs, are being developed.  These will be released in the coming weeks.  In the interim, please continue to use the current process for recruitment and set up of PICs.

22/05/2019: Update on UK Local Information Pack

Setting up NHS/HSC research in the UK: Update on UK Local Information Pack

Implementation of the UK Local Information Pack is confirmed for 5 June 2019. It will be important to remember that from this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  From this date the Statement of Activities and Site Specific Information form will no longer be in use.

The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

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

Delegation Logs

Following feedback we have clarified the use and inclusion of the delegation log. Delegation Logs are required for all interventional studies requiring a local Principal Investigator. Sponsor will need to indicate if this is being provided with the UK Local Information Pack or if this is being provided at a later date i.e. following Site Initial Visit. The Q&As have been updated with regard to this. 

Further webinars will be held on 30 May at the following times 9.15am, 11.00am, 13.00pm and 14.30pm. To register sign on here.

16/04/2019: Preparing for change on 5 June 2019

Setting up NHS/HSC research in the UK: Preparing for change on 5 June 2019

A UK Local Information Pack will be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UK. Researchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

The UK Local Information Pack is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. More information is given in the Local Information Pack section of IRAS Help but there are some key features: 

  • One new feature of the UK Local Information Pack is the Organisation Information Document, which will replace the current Statement of Activities used in England and Wales for non-commercial studies and the Site Specific Information Form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and NHS / HSC Site Specific Information Form will no longer be in use.

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 for both commercial and non-commercial research. 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.

  • Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study.
  • For non-commercial studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

Guidance on the use of the UK Local Information Pack has now been published in the Site-Specific page of IRAS Help to help applicants get ready for the change. If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from 5 June 2019 please read the transition guidance so that you prepare the correct materials.

To support researchers and NHS / HSC organisations make the transition to using UK Local Information Packs, change management activities will be scheduled throughout April and May, with continuing support following implementation in June. Webinars have been scheduled to support the change (if you have not previously used the new HRA Learning Management System please register for an account via the link).

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

13/03/2019: A UK Local Information Pack will be introduced on 5 June 2019

Setting up NHS/HSC research in the UK: A UK Local Information Pack will be introduced on 5 June 2019

Following on from the previous communication in February, it is confirmed that a UK Local Information Pack will be introduced on the 5th June 2019. From this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and Site Specific Information form will no longer be in use.

The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK. 

The Organisational Information Document template will be made available from end April 2019.  

Regular communications and updates will be available on the four nations NHS/HSC compatibility website. 

19/02/2019: Implementing a UK Local Information Pack

Setting up NHS/HSC research in the UK: Implementing a UK Local Information Pack


A UK Local Information Pack is being introduced in the summer of 2019.  Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.  A specific implementation date will be announced in March along with further guidance.

The current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland, will be replaced by an Organisation Information Document.

Regular communications and updates will be available on the four nations NHS/HSC compatibility website. 

Work delivered so far

  • Use of the combined REC and R&D IRAS form across the UK (June 2017)
  • Interim step (ahead of development in IRAS) in Wales to use HRA paperwork to replace SSI forms and introduce confirmation of capacity and capability.

Work under development

  • Simultaneous e-submission to REC and Study wide review for Scotland, Wales and NI (already in place for England)
  • Introduction of a local information pack in IRAS to replace emailing local information pack in England, replacement of Statement of Activities for non-commercial studies, and use of SSI form use in Scotland, Wales, and Northern Ireland
  • NHS Permission with confirmation of capacity and capability for Scotland and Northern Ireland.