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UK Local Information Pack: Questions and Answers

Local Information Pack

What is the UK Local Information Pack?

The UK Local Information Pack is the group of documents that is provided to NHS / HSC organisations to set up research studies. The majority, but not all, of the components will have been submitted as part of the IRAS Form submission. The UK Local Information Pack comprises:

  • Template email
  • Localised Organisation Information Document
  • Copy of submitted IRAS Form
  • Current Protocol
  • Participant information and consent documents (without local logos/ headers) as relevant to the activities taking place at the participating NHS / HSC organisation
  • Relevant model agreement, if applicable
  • Commercial studies only – NIHR Costing template or confirmation that the on-line iCT has been completed
  • Non-commercial studies only – IRAS Schedule of Events or SoECAT
  • Delegation log (This is required for all interventional studies requiring a principal investigator. The sponsor must indicate if this is being provided at a later date ie SIV) 
  • Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
  • For England and Wales: Copy of HRA and HCRW Initial Assessment Letter (if one is issued) and (when issued) HRA and HCRW Approval Letter.

IRAS Help contains more information on the UK Local Information Pack.

How is the UK Local Information Pack shared?

Email templates are to be used to share UK Local Information Packs and are available in IRAS Help. NHS / HSC organisations will not accept the pack unless the appropriate email template has been used.

NHS Organisations in Scotland: Localised Organisation Information Documents and delegation logs (the sponsor must indicate if this is being supplied later, when one is required) are emailed to the NRS Permissions Coordinating Centre (nhsg.NRSPCC@nhs.net) who then share the complete Local Information Pack, on behalf of the Sponsor, with participating NHS organisations in Scotland and the relevant research network.

There is no requirement to resend documents submitted with the IRAS Form as these will have been made available to the participating NHS organisations.

NHS / HSC organisations in England, Northern Ireland and Wales: Local Information Packs, which contain localised Organisation Information Documents, are shared with participating NHS / HSC organisations in England, Northern Ireland and Wales by email from the sponsor, or their authorised delegate, to the NHS/HSC R&D office, local study team and, where applicable, the relevant research network.

In Northern Ireland the HSC R&D office will facilitate sharing with the relevant research network.

When can I share the Local Information Pack with participating NHS / HSC organisations?

Northern Ireland and Scotland: The Local Information Pack can be shared with participating NHS / HSC organisations in Northern Ireland and Scotland after the applicant has received notification that their IRAS Form submission is valid.

England and Wales: The Local Information Pack can be shared with participating NHS organisations in England and Wales after the applicant has received the Initial Assessment or HRA and HCRW Approval Letter.

Once the Local Information Pack can be shared, it is up to the sponsor or authorised delegate to decide when the most appropriate time is to share the pack and this will depend on their delivery plan for the study.

Can an NHS / HSC organisation reject a Local Information Pack?

An NHS / HSC organisation can reject a Local Information Pack under the following circumstances:

  • If it is immediately obvious that the organisation will not be able to take part in the study. Letting the sponsor know quickly that the organisation will not take part in the study is important
  • The documents listed in the email template have not been attached.

For interventional studies it is expected that the sponsor has been in previous correspondence with participating NHS / HSC organisations to discuss feasibility, etc. For non-interventional studies sharing the Local Information Pack may act as an invitation to participate but where possible it helps study set up for early conversations to be had between the sponsor or authorised delegate and the participating NHS/HSC organisation.

What are the Local Information Pack arrangements if an NHS / HSC organisation is both sponsor and a participating NHS / HSC organisation?

Where an NHS / HSC organisation is both sponsor and a participating organisation, there is no requirement for the sponsor to share a Local Information Pack with itself. Different teams within the NHS / HSC organisation are assumed to be communicating about the set-up of the study. NHS / HSC organisations acting as sponsors should have clear written procedures relating to self-sponsored studies. This applies to single and multi-centre studies.

Organisation Information Document

What is an Organisation Information Document?

An Organisation Information Document is a Word document that provides information to the participating NHS / HSC organisations to support the set-up of research. There are commercial and non-commercial versions. It is a constituent part of the UK Local Information Pack.

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 other than clinical trials and clinical investigations, the Organisation Information Document should also be used as the agreement between sponsor and participating NHS / HSC organisation.

There is specific guidance provided to support the creation of outline and localised Organisation Information Documents. One key element of the outline Organisation Information Document is that it clarifies whether a Principal Investigator or a Local Collaborator or neither is required to be in place at participating NHS / HSC organisations. Further details are given in the Organisation Information Document and guidance.

Do I need to submit an Organisation Information Document with my IRAS Form submission?

Yes. An outline Organisation Information Document should be attached to the IRAS Form checklist and submitted along with the other documents on the checklist. The IRAS checklist will be updated to provide a row on which to attach outline Organisation Information Documents.

An outline Organisation Information Document gives information that will be common to all participating NHS / HSC organisations undertaking the same activities within the study. For some studies some organisations will undertake different activities to others; for example, where recruitment and intervention is undertaken in one participating NHS / HSC organisation and follow up undertaken in separate participating NHS / HSC organisation (a participating NHS / HSC organisation is taken to mean the legal entity e.g. NHS Trust or Health Board rather than constituent locations within the participating NHS / HSC organisation). In this case more than one outline Organisation Information Document may be needed.

Do I need an outline Organisation Information Document for single centre studies?

For NHS / HSC sponsored studies planned as a single centre study taking place only at that NHS / HSC organisation, there is no requirement to create an outline Organisation Information Document for submission with the IRAS Form or to have a Local Information Pack.

If additional participating NHS / HSC organisations are added to the study by amendment, an outline Organisation Information Document will need to be created and submitted with the amendment. Applicants are strongly encouraged to realistically plan for the expected number of participating NHS / HSC organisations even if they have not yet been identified.

We work very closely with our partner university and know about all the studies they are running in our organisation. Is a Local Information Pack and Organisation Information Document still required?

Where an NHS organisation in England, Scotland or Wales works closely with a partner Higher Education Institution (HEI) in a Joint Research Office or similar arrangement, the NHS organisation may choose to treat single centred studies sponsored by their partner HEI in the same way as those studies sponsored by that NHS organisation.

Where the HEI is the sponsor a study-specific data processing agreement will need to be in place between the sponsor and the NHS organisation to fulfil the requirements of GDPR. A simplified Organisation Information Document is available, which can be used as an agreement for GDPR purposes.  Each national coordinating function will maintain a list of NHS organisations that choose to work under these arrangements with specific HEIs (this so they can be clear when to request Organisation Information Documents). The decision to work in this way rests with the NHS organisations. If unsure of local arrangements please discuss with your HEI / NHS Sponsor team.

Do I need to update the outline Organisation Information Document before sharing with participating NHS / HSC organisations as part of the Local Information Pack?

Yes. Organisation Information Documents are localised to make them specific to the NHS/HSC organisation you are sharing the Local Information Pack with.

There are circumstances in which the Organisation Information Document may be shared with participating NHS / HSC organisations without first being localised, e.g. for low-risk studies when sharing the document with a large number of potential participating NHS / HSC organisations. If potentially applicable please consult with your national coordinating centre to discuss whether such an approach may be appropriate for your study.

IRAS Schedule of Events / Schedule of Events Cost Attribution Template (SoECAT)

Do I need to include a Schedule of Events or a SoECAT with my IRAS Form Submission and in UK Local Information Packs?

For non-commercial studies it is important that there is clarity for participating NHS / HSC organisations about how the costs associated with participating in a study are attributed. This will help to ensure that the appropriate resources are identified to support study delivery.

For all non-commercial studies an IRAS Schedule of Events or a SoECAT is required. See IRAS Help.

If an AcoRD specialist authorised SoECAT has been completed as part of a funding application, then please supply the SoECAT. If any of the details have changed during the funding process these should be reflected in the SoECAT submitted with the IRAS Form. The SoECAT will have to be reauthorised by an AcoRD specialist.

If a SoECAT has not been completed as part of the funding application, then please supply an IRAS Schedule of Events. 

  • England: If the study is intended for the NIHR portfolio please consult with your local AcoRD Specialist on which of the two Schedules of Events is most appropriate for your study
  • Northern Ireland: If it is anticipated that the study intervention will incur any Excess Treatment Costs and is taking part in Northern Ireland an AcoRD specialist authorised SoECAT will be accepted. There may be an additional requirement for a separate application form; in all cases, please contact HSC R&D Division to discuss
  • Scotland: It is the responsibility of the R&D office of the lead Scottish Health Board to work with applicants to identify any Excess Treatment Costs, and submit a subvention application to CSO. If an AcoRD specialist authorised SoECAT is not supplied, please contact the local R&D office for advice
  • Wales: If the study intervention will incur any Excess Treatment Costs and is taking part in Wales, Wales will accept the AcoRD Specialist authorised SoECAT.  If an IRAS Schedule of Events is used, an additional ETC application form will also be required.

Delegation Log

Do I need to include a delegation log as a component part of the UK Local Information Pack?

A delegation log held at the participating NHS / HSC organisation is important for all studies where the type of study is interventional (one of the first four categories in IRAS Form filter question 2) and where the local research activities are managed by a principal investigator. It provides clarity regarding who is responsible for undertaking what activity during delivery of the study. The delegation log is a tool to be maintained throughout the lifetime of the study at that participating NHS / HSC organisation.

The sponsor may share the delegation log that will be used in the study as part of the Local Information Pack or they may indicate on the template email sharing the Local Information Pack when the delegation log will be shared with participating organisations (eg. after the site initiation visit or training event, etc.)

Where a delegation log is shared with the Local Information Pack, the names of those working on the study may be listed where they are known but signatures are not required at this stage but are put in place during site set up. 

The delegation log is not the appropriate place to indicate to the participating NHS/HSC organisation that staff not employed by the participating NHS/HSC organisation will be coming onto their premises. Where an external researchers, not employed by participating NHS/HSC organisation, will be coming on to the site to deliver research activities, this should be indicated in the Organisational Information Document and discussed during site set up.

An example template delegation log is available in IRAS Help but sponsors may use their own delegation log templates if they prefer. 

Delegation logs do not need to be completed before being sent as part of the Local Information Pack but if the names of staff who will be working on the study are known it can be helpful to include these.

 

Transitional arrangements

See IRAS Help.

Scotland and Northern Ireland: I have created an NHS / HSC SSI Form but it has not yet been submitted to an NHS / HSC organisation?

SSI Forms created before 5 June 2019 that have not been submitted to R&D offices in NHS / HSC organisations in Northern Ireland or Scotland will not be accepted by sites after 5 June.  A UK Local Information Pack will be expected. Please prepare a localised Organisation Information Document for use from 5 June. The guidance and templates are provided in IRAS Help. 

If you have transferred the SSI Form via IRAS to the local study team but they have not yet submitted it to their NHS / HSC R&D office, the changes in IRAS will mean that they cannot submit it after 5 June. Please recall it and explain that you will be providing a Local Information Pack.

In order to support a smooth transition, please do not leave the submission of SSI Forms until the last minute – NHS / HSC R&D offices may not be able to deal quickly with rushed submissions.

England and Wales: What do I do if I have created a Statement of Activities?

From 5 June 2019, Local Information Packs containing Statement of Activities will not be accepted by NHS organisations in England or Wales. If you have created a localised Statement of Activities but did not share it with an NHS organisation before 5 June, or are in the process of setting up additional NHS organisations, transfer the information from the Statement of Activities to an Organisational Information Document. Any future NHS organisations will be set up using the Organisational Information Document.

If you already have a Statement of Activities that has been submitted with an IRAS Form you do not need to submit an outline Organisation Information Document, as the data contained in both documents is very similar. If by amendment you are changing the way in which the study is delivered, which means you would have created a new or updated Statement of Activities, then please create and submit an outline Organisation Information Document with the amendment.

How is the NHS / HSC SSI functionality changing in IRAS?

From 5 June 2019, the functionality to create and submit NHS / HSC SSI Forms will be removed from IRAS. Any forms created before 5 June 2019 will remain in IRAS but you will not be able to print SSI forms for submission from 5 June. SSI forms will not be accepted at NHS / HSC organisations from 5 June 2019. Please plan ahead if you are setting up sites at the switch over.

Are non-NHS / HSC SSI Forms changing?

Yes, non-NHS SSI Forms will also be removed from IRAS and alternative arrangements put in place. Further information will be provided in due course.

When will outline Organisational Information Documents be accepted as part of the IRAS submission? Can I submit an outline Organisation Information Document with my IRAS Form submission now as I will be setting up my participating NHS / HSC organisations after 5 June 2019?

Yes, from 15 April 2019 we will be accepting outline Organisation Information Documents with IRAS Form submissions. However, localised Organisation Information Documents can only be shared with participating NHS / HSC organisations from 5 June 2019.

Do I create both SSI Forms and/or Statements of Activities, in addition to outline Organisational Information Documents for my submission if my sites are likely to straddle the 5 June 2019?

Yes. If your study set up plan covers the time period before and after 5 June 2019 you will need to use existing arrangements up to the 5 June and the new arrangements thereafter. See IRAS Help.

Slides used for UK Webinars

Slides used for UK Webinars on 10, 15 and 30 May:

SoECAT and OID Examples

Example Organisational Information Documents and Schedule of Events Cost Attribution Templates (SoECATs)

Site Type A.zip

Site Type B.zip

Site Type C.zip

Example Study Overview

This is a non-interventional study recruiting stroke patients soon after stroke to complete questionnaires at various time points over two weeks. It is expected, as per standard of care, that patients will move from an acute hospital to a community hospital setting whilst they are in the study.

Example Outline Organisational Information Documents and SoECATs for IRAS Submission

There are three SoECATs and three outline Organisation Information Documents prepared for submission:

  • Site Type A – intended for English acute hospitals. Patients here will be recruited and undertake questionnaires at some of the early time points.
  • Site Type B – intended for English community settings, where patients will continue their recovery. Activities at this hospital will be to complete the later timepoint questionnaires following referral
  • Site Type C – intended for organisations in Northern Ireland, Scotland or Wales. Here, the acute hospital and community hospitals are within the same legal entity, so the documents detail the activities that will occur at both hospitals within the one SoECAT and Organisation Information Document.

A SoECAT and outline Organisation Information Document has been prepared for for each scenario, to reflect the arrangements as per study team expectations.

Example Localisation of Organisational Information Documents

  • Orchard Hospitals NHS Foundation Trust (Site Type A)
  • Berrybush Community NHS Trust (Site Type B)
  • NHS Maple Wood (Site Type C).

Documents are localised with known information and shared with participating NHS / HSC organisations (using standard template emails, examples included).

Examples of Agreement of Localised Organisational Information Documents

  • Orchard Hospitals NHS Foundation Trust (Site Type A)
  • Berrybush Community NHS Trust (Site Type B)
  • NHS Maple Wood (Site Type C).

Noting that during study set-up some information was added to the localised Organisational Information Document, and some amended, to reflect local arrangements.

Feedback

Local Information Pack Feedback

We always welcome feedback about your experience of using the UK Local Information Pack implemented in June 2019 and used to support set up and delivery of research in NHS / HSC organisations across England, Northern Ireland, Scotland and Wales.

Your feedback will be reviewed by the Four Nations Compatibility Programme and please be assured that it will be considered as part of our continuous improvement work and to inform future IRAS developments.  Your feedback is treated in confidence.

You can optionally choose to be identified and we may contact you to further explore any issues/concerns/good ideas you may have.

You may leave questions blank if you prefer not to answer.
 
You have the right to withdraw your consent for feedback data to be used by the HRA, NHS Research Scotland, Health and Social Care Northern Ireland and Health and Care Research Wales. If you wish to withdraw your consent, please email hra.qa@nhs.net to advise that you wish to withdraw consent and all feedback data (and identified as you providing) will be deleted.

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