PSP083: Non-commercial application routes for Research Delivery Network support: Guidance and Principles

The two main routes for applying for support from the Research Delivery Network (RDN) for English-led non-commercial studies are the submission of an IRAS Form through the Health Research Authority (HRA) Standard Integrated Research Application System (IRAS), and, submission via the Non-commercial Portfolio Application service (NPA) in the RDN’s Central Portfolio Management System (CPMS).

Submissions that are made via standard IRAS are received automatically into CPMS via an Application Programming Interface (API) when the applicant selects “yes” to question 5b of the project filter on the IRAS Form. This provides the Portfolio Eligibility Team with the necessary information to perform an eligibility review. As the development of a new version of IRAS progresses it is anticipated that this submission route will be phased out and replaced with the NPA.

The NPA service is an online application service that enables study teams to apply for support from the RDN directly through CPMS. It allows investigators to apply for support earlier, once they have secured research funding, and receive an eligibility decision sooner to benefit from the full range of support that the Study Support Service offers. Investigators/study teams can access the NPA using the green button on the CPMS Homepage ‘Apply for a service for a new study’’ or via the ‘My service applications’ dashboard can be accessed using the left-hand menu. Regional Research Delivery Network (RRDN), RDN Coordinating Centre and Devolved Administration staff can view NPA applications using the “Non-commercial Portfolio Applications” tab. Guidance documents are available on NIHR Learn.

The NPA service is available to all English-led studies, with the following exceptions:

• Studies that are applying for HRA Approval through the standard IRAS. These studies should continue to apply for support from the RDN by selecting ‘yes’ to question 5b of the IRAS Project Filter.

• Studies that are fully supported by other NIHR Research Infrastructure. These will not require additional support from the NIHR RDN and need not apply.

There are a small number of studies that use standard IRAS to gain regulatory approval for their study but which are not automatically received into CPMS e.g. new sub-studies/follow-on studies that have been approved via a substantial amendment to a main/ previous study or studies that are already open to recruitment.  These studies should apply via the NPA. Further information regarding how these studies can make an application for support from the RDN can be found in Annex A (this is also available further down on this page).

The purpose of this document suite is to define each non-commercial  application route for support from the RDN and outline the guidance, principles and process applied to each route to ensure clarity and transparency across the NIHR RDN. 

The supporting Annexes describe the application routes in further detail:

Annex A: Guidance and principles for applications for support from the RDN received in CPMS (for non-commerical English-led studies)

Annex B: Guidance and principles for applications for support from the RDN received via email (for non-commercial Devolved Administration-led studies with English sites)

Commercial studies should always be submitted via the standard CPMS submission process.

This document outlines:

• Which studies are able to apply for support from the RDN through each application route.

• The guidance and principles applied to each application route.

This document does not capture the process for the study record management of studies in CPMS nor does it include details on the implementation of the Eligibility Criteria.

This route enables applications for support to be made directly to the RDN via CPMS. 

 The NPA  is available to all English-led studies, with the following exceptions:

• Studies that are applying for HRA Approval through standard IRAS. These studies should continue to apply for NIHR RDN Support by selecting ‘yes’ to question 5b of the IRAS Project Filter.

• Studies that are fully supported by other NIHR Research Infrastructure. These studies will not require additional support from the NIHR RDN and need not apply. 

It is acknowledged that the eligibility of a study can change over its life cycle and that studies which originally answered yes to 5a on the IRAS project filter  ‘Are all the research costs and infrastructure costs (funding for the support and facilities needed to carry out research e.g. NHS Support costs) for this study provided by a NIHR Biomedical Research Centre, NIHR Applied Research Collaborations (ARCs), NIHR Patient Safety Research Collaborations (PSRCs)  or NIHR HealthTech Research Centres in all study sites?’ may later require support from the RDN. 

The following study types are not automatically received into CPMS  and therefore they should apply via the NPA :

• New sub-studies/follow-on studies approved via a substantial amendment to a main/ previous study 

• Studies requiring HRA approval for which the IRAS project filter has been incorrectly completed 

• Studies that have been closed for more than 12 months but wish to re-open 

• Studies that are open to recruitment 

• Non-RDN NIHR Infrastructure studies that have had a change of circumstances during the study lifecycle and may now be eligible for additional support from the RDN. This includes studies that are already open to recruitment at NIHR Infrastructure supported sites that have received additional funding or those that need to open at additional sites that are not supported by NIHR Infrastructure.

The submission route field in the CPMS study record  for studies received  via the NPA is recorded as “Non-commercial Portfolio Application service”.

Requirements: To complete an NPA  a copy of the study protocol and evidence of the research funding that has been secured are required. All mandatory data items in the application form must be completed. The RDN accepts the details of the host organisation in place of a sponsor for public health studies that do not involve the NHS.

This is the application route used by the majority of English-led non-commercial studies. Once an IRAS form has been validated by the HRA in standard IRAS,  if  ‘yes’ has been selected to question 5b of the IRAS Project Filter indicating the need for support from the RDN, the study is automatically received into CPMS via an Application Programming Interface (API).  Provided all supporting information has been included, the Portfolio Eligibility  Team will review the application for support from the RDN.

Requirements:  The evidence of research funding that has been secured and the study protocol that are supplied with the IRAS submission are subsequently received into CPMS. If they are not supplied, or are not suitable, then they will be requested on receipt of the application. 

The submission route field in the CPMS study record for studies received by this mechanism is recorded as "CPMS-IRAS API"

These studies are not received into CPMS via the NPA or the CPMS-IRAS API, and therefore, an email application for support from the RDN is required. The HRA or Devolved Administration (DA) will notify the Portfolio Eligibility Team by email if a study is received where the study team has indicated in their IRAS submission a need for support from the RDN at English sites.  

The Lead RRDN will be allocated by the Portfolio Eligibility Team and this is determined by where the English site(s) are based. 

The Portfolio Eligibility Team will retrieve the following documents from the HRA Approval Portal or will request that they are supplied as part of an email application:

• Evidence of all available funding

• Study Protocol

• Evidence of appropriate approvals and;

• The final IRAS Form/Project Study Information form (draft versions will not be reviewed). 

Requirements: The full documents described above.  

This will provide the Portfolio Eligibility Team with the additional information required to perform a review. Once all documents have been received, these studies will be assessed in the same way as those received via the NPA or CPMS-IRAS API. The Policy and Principles are captured in more detail in  Annex B.

The submission route field in the CPMS study record  for these studies is recorded as “Email (study led by Devolved Administration)”.

API: Application Programming Interface

ARCs: Applied Research Collaborations 

CPMS: Central Portfolio Management System

CTIMP: Clinical Trials of Investigational Medicinal Products

DA: Devolved Administration

HRA: Health Research Authority

IRAS: Integrated Research Application System

MHRA: Medicines and Healthcare Products Regulatory Agency

NIHR: National Institute for Health and Care Research

NPA: Non-commercial Portfolio Application service

PSRC: Patient Safety Research Collaborations 

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre

REC: Research Ethics Committee

RRDN: Regional Research Delivery Network

Version number: Version 3.2

Effective from date: 1 October 2024

The two main routes for applying for support from the Research Delivery Network (RDN) for non-commercial English-led studies are the submission of an IRAS Form through the Health Research Authority (HRA) standard Integrated Research Application System (IRAS) and submission via the Non-commercial Portfolio Application service (NPA) in the RDN’s Central Portfolio Management System (CPMS). 

Submissions that are made via standard IRAS are received automatically into CPMS via an Application Programming Interface (API) when the applicant selects "yes" to question 5b of the project filter on the IRAS Form. This provides the Portfolio Eligibility Team with the necessary information to perform an eligibility review. As the development of a new version of IRAS progresses it is anticipated that this submission route will be phased out and replaced with the NPA.

The NPA service is an online application service that enables study teams to apply for support from the RDN directly through CPMS. It allows investigators to apply for support earlier, once they have secured research funding, and receive an eligibility decision sooner to benefit from the full range of support that the Study Support Service offers. Investigators/study teams can access the NPA using the green button on the CPMS Homepage ‘Apply for a service for a new study’’ or via the ‘My service applications’ dashboard that can be accessed using the left-hand menu. Regional Research Delivery Network(RRDN), RDN Coordinating Centre and Devolved Administration staff can view NPA applications using the “Non-commercial Portfolio Applications” tab. Guidance documents are available on NIHR Learn. 

The NPA is now available to all English-led studies with the following exceptions:

• Studies that are applying for HRA Approval through standard IRAS. These studies should continue to apply for support from the RDN by selecting ‘yes’ to question 5b of the IRAS Project Filter.

• Studies that are fully supported by other NIHR Research Infrastructure. These will not require additional support from the NIHR RDN and need not apply. 

There are a small number of studies that use standard IRAS to gain regulatory approval for their study but which are not automatically received into CPMS e.g. new sub-studies/follow-on studies that have been approved via a substantial amendment to a main/ previous study or studies that are already open to recruitment.  These studies should apply via the NPA. Further information regarding how these studies can make an application for support from the RDN can be found in Annex A (this is also available further down on this page).

The purpose of this document suite is to define each non-commercial application route for support from the RDN and outline the guidance, principles and process applied to each route to ensure clarity and transparency across the NIHR RDN. 

The supporting Annexes describe the application routes in further detail:

Annex A: Guidance and principles for applications for support from the RDN received in CPMS (for non-commercial English-led studies)

Annex B: Guidance and principles for applications for support from the RDN received via email (for non-commercial Devolved Administration-led studies with English sites)

Commercial studies should always be submitted via the standard CPMS submission process. 

This document outlines:   

• Which studies are able to apply for support from the RDN through each application route.

• The guidance and principles applied to each application route.

This document does not capture the process for the study record management of studies in CPMS nor does it include details on the implementation of the Eligibility Criteria.

1) An English-led CTIMP using the HRA & MHRA’s combined review 

Non-commercial studies applying for ethical and regulatory approval for CTIMPs through the HRA & MHRA’s combined review in new IRAS should apply for support from the RDN via the NPA. Combined review studies are not automatically received into CPMS via the CPMS-IRAS API; the NPA is, therefore, the only way that non-commercial CTIMPs can apply for RDN support. 

2) An English-led study which does not require HRA Approval (i.e. those taking place in public health and social care settings).

Non-commercial studies that do not require HRA Approval should apply for support from the RDN via the NPA. This includes any study seeking REC approval only and not HRA Approval (i.e. Social Care REC, Research Tissue Bank REC, Research Database REC, NHS REC, Higher Education Institution REC or study-specific REC). 

The NPA is the only way these studies can apply for support from the RDN.

3) An English-led  study that has already indicated that RDN support is not required in question 5b of the standard IRAS project filter.

When question 5b on the IRAS project filter, “Do you wish to make an application for the study to be considered for NIHR Research Delivery Network (RDN) Support and inclusion in the NIHR RDN Portfolio?” is set to ‘yes’, key information from the IRAS submission will be automatically shared with CPMS via the CPMS-IRAS API. 

When question 5b is set to ‘no’, the study will not be shared with CPMS via the CPMS-IRAS API.

Once the initial IRAS submission has been made the answer to question 5b cannot be amended to create an application for support from the RDN. If these studies do wish to apply for support from the RDN they should apply via the NPA which is the only application route available.

4) An English-led sub-study or a follow-on study approved via a substantial amendment to a main/previous study.

A sub-study that is approved via a substantial amendment to a main study as opposed to via a new ethics application, would not usually be viewed as a separate study in its own right. However, if the sub-study has been awarded additional/separate funding to the previous main study and meets the criteria laid out in point 7 of the recruitment policy, it may be considered as a separate study. As a new ethics application is not required,  these studies cannot apply for NIHR RDN support via the CPMS-IRAS API and therefore need to apply via the NPA which  is the only way in which these studies can apply for support from the RDN.

It is likely, in this scenario, that there will be an existing CPMS study record that contains the same IRAS ID. When there is a duplicate IRAS ID a new study record in CPMS will need to be created. Please refer to the process flow for studies with a duplicate IRAS ID and Appendix A for additional guidance.

5)  An English-led study which is closed in CPMS but wishes to re-open.

Studies, and their corresponding records in CPMS, may be re-opened on confirmation of an agreed extension to the study. However, if a study closed more than 12 months ago, or it is not an extension of the same study (i.e. new research question/new funding), then eligibility for a new application for support from the RDN is required. These will be considered on a case by case basis and need to be submitted via the NPA which is the only way an application for support from the RDN can be made.

It is likely, in this scenario, that there will be an existing CPMS study record that contains the same IRAS ID; a duplicate IRAS ID, and therefore that a new study record in CPMS will need to be created. Please refer to the process flow for studies with a duplicate IRAS ID and Appendix A for additional guidance.

6)  An English-led study which is already open to recruitment at one or more sites.

Although it is strongly recommended that an application for support from the RDN is made as soon as funding is secured, applications are accepted for studies that are at a later stage. Studies that are open to recruitment can make an application for support from the RDN via the NPA which is the only application route available to open studies. 

Applications for studies in their last six months of recruitment (or equivalent percentage for shorter studies) will not be considered. Studies with a short recruitment window (i.e. open for six months or less) must have at least half of their recruitment period left. This is to ensure that the RDN has enough time left to benefit the study. 

The Chief Investigator, Study Sponsor and Lead RRDN will receive an automated email once the application has been submitted. This provides details of the submission including the study planned opening date and advises the Chief Investigator to contact their Lead RRDN as their study is already open to recruitment.

Recruitment data for non-commercial studies is required from the date the study is deemed eligible i.e. the "Date of Eligibility Decision" in CPMS. The study team and/or Lead RRDN should liaise with the Portfolio Monitoring Team to set an appropriate sample size to reflect the remaining recruitment period. 

Recruitment data which dates back to the start of the study should not be uploaded. However, if there is a valid reason for uploading retrospective data this will be assessed by the Portfolio Monitoring Team on a case by case basis.

Further guidance is outlined in point 3 of the NIHR Recruitment Policy Document. 

7) An English-led study that  is funded by NIHR Infrastructure, which has previously applied for support unsuccessfully,  but which has had a change of circumstances and may now be eligible for additional support from the RDN

This includes: 

• Studies that are already open to recruitment at Non-RDN NIHR Infrastructure supported sites but which have secured additional funding from other NIHR research programmes, NIHR Non-commercial Partners or other areas of central government (including research councils)

• Studies that need to open at additional sites that are not supported by NIHR Infrastructure (i.e. not the contracted NHS/University partnership and/or formal partners) that are involved in study activities (e.g. recruitment).

These studies can make an application for support from the RDN via the NPA which is the only application route available. 

If a study funded by Non-RDN NIHR Infrastructure has previously applied for support (whether via the CPMS-IRAS API or the NPA) it is likely, in this scenario, that there will be an existing CPMS study record that contains the same IRAS ID; a duplicate IRAS ID, and therefore that a new study record in CPMS will need to be created. Please refer to the process flow for studies with a duplicate IRAS ID and Appendix A for additional guidance.

Please note that if a study funded by Non-RDN NIHR Infrastructure which has additional funding or is open to external sites as described above from the outset answers “no” to question 5a and “yes” to question 5b in standard IRAS at the time of application for regulatory approvals then the study will be received into CPMS via the CPMS-IRAS API. 

If a study funded by Non-RDN NIHR Infrastructure has selected “yes” to 5a (either correctly or in error) in standard IRAS, or is applying for regulatory approvals via combined review, or does not need and is therefore not applying for HRA Approval then the study will not be received by the CPMS-IRAS API and therefore an application will need to be made via the NPA if support from the RDN is required. 

8) Support is required from the RDN to find additional sites  outside of the Non-RDN NIHR Infrastructure.

It is recognised that some sites may not wish to participate in a study unless it already has support from the RDN. To address this, if additional sites are required to meet the recruitment target of an NIHR Infrastructure funded study,  an application can be submitted prior to the new sites being identified and/or opened.

A study that is taking place in the NHS and therefore requires HRA Approval but it is not a CTIMP using the HRA & MHRA’s combined review in new IRAS.

All project-based research that is taking place in the NHS in England must apply to the HRA in order to receive the required approval to open and deliver the study.  

1) The study is NOT fully supported at all sites by an NIHR Infrastructure award (i.e. all the Research Costs and Support Costs are met). 

If all the research costs and infrastructure costs (funding for the support and facilities needed to carry out research e.g. NHS Support costs) for this study are provided by a NIHR Biomedical Research Centre, Applied Research Collaboration (ARC), Patient Safety Research Collaborations (PSRCs), Diagnostic Evidence Co-operative, NIHR Health Tech Research Centre in all study sites, an application for additional support from the RDN should not be required.

During the eligibility review, the Portfolio Eligibility Team will consider whether NIHR Infrastructure supported studies require additional support from the RDN and if it is unclear, will query this with the lead RRDN. It is the lead RRDN’s responsibility to respond accurately and in a timely manner to such requests. Where additional support is considered necessary, the NIHR Infrastructure funding will be considered conditionally eligible (i.e. subject to confirmation of peer review in line with Eligibility Criteria). However, if additional automatically eligible funding is also in place this may be used for the eligibility assessment.

2) Studies that have previously been deemed ineligible for support from the RDN  cannot be considered via the NPA unless the circumstances have changed (i.e. new funding has been secured). 

To be deemed eligible for support from the RDN studies must meet the Eligibility Criteria, and satisfy the following additional criteria:

1. The study must have a Chief Investigator that is based in the UK.

2. If the Sponsor is based outside the UK or is not on an approved country list (which initially includes EU / European Economic Area (EEA) countries) it may require a legal representative.

3. A signed funding agreement/contract or a letter/email from the funding organisation confirming that funding has been secured must be provided. Studies that are funded by a large programme/centre grant should provide evidence from the funding organisation that the overarching award has been secured and confirmation from the grant recipient/host organisation of the amount that will be assigned to the study.

4. A study protocol must be included

1. A full application must be submitted via the NPA before the eligibility review is started. A full application should include:

• All mandatory data items as noted in the online application form;

• Evidence of funding (e.g. grant award letter, signed contract with the funders); 

• Study Protocol; and

• For studies that do not require HRA Approval, evidence of REC approval if available at the time of application (optional)

Applications can, and should, be made as soon as research funding is secured. There is no need to wait until an application for ethical/regulatory approval is made. The RDN accepts the details of the host organisation in place of a sponsor for public health studies that do not involve the NHS. 

2. The application must be deemed valid. An invalid application will be reverted to the researcher and the status within CPMS will be changed to ‘Action required’. The researcher will also receive an email outlining what changes are required. They can then resubmit the application when the outstanding items have been addressed.

This service enables all National Portfolio Managers and Local Portfolio Managers to view, in real-time, the application status and information relating to the eligibility review. 

1. A full application must be submitted via standard IRAS in order for the study to be received in CPMS.

When question 5b on the IRAS project filter, “Do you wish to make an application for the study to be considered for NIHR Research Delivery Network (RDN) Support and inclusion in the NIHR RDN Portfolio?” is set to ‘yes’, key information from the IRAS submission will be automatically shared with CPMS via the CPMS-IRAS API once the IRAS form has been validated by the HRA.

Provided all supporting information has been included, the Portfolio Eligibility Team will review the application for support from the RDN. A full IRAS application should include:

• Evidence of funding (in the form of a valid and current grant award letter, a signed contract or email from the funder); 

and

• Study protocol

If funding evidence is uploaded to IRAS as a document type other than “Evidence of funding” this will not be received by CPMS and the Portfolio Eligibility Team will request this from the lead RRDN.

Further guidance can be found in the Top-Tips for the IRAS API Portfolio Eligibility Process document. 

To: portfolio.applications@nihr.ac.uk

CC:Chief Investigator and/or main study contact 

Dear Portfolio Eligibility Team, 

Following discussion with the study team, I would like to request PET support to enable them to proceed with their application for support from the RDN via the Non-commercial Portfolio Application service. 

The user is unable to continue to the application because they are entering an IRAS ID that already exists in CPMS for: 

[Delete as appropriate] 

• A sub-study that has all of the following:

  • • Approved via a Substantial amendment 

    • Funding that is separate from the main study 

    • Separate consent process from the main study or consenting additional participants

    • Requires significant additional/different support from the RDN to the main study 

    • Addressing different/additional outcomes to those of the main study 

• A closed study that wishes to reopen

• A study funded/ by Non-RDN NIHR Infrastructure that was previously 'not applicable' for support from the RDN, but now has additional collaborating site(s) and/or additional automatically eligible funding

• A study that has previously applied for support from the RDN that was deemed ineligible but their circumstances have changed and they wish to reapply 

Please see below the information required to progress the application: 

IRAS ID :

Short title: 

Long title :

Chief Investigator contact details : Full Name: ___________________ Email Address: ______________________

Main study contact details (if different from the CI ): Full Name: ___________________ Email Address: ______________________

Lead Administration:

Kind regards, 

The two main routes for applying for support from the Research Delivery Network (RDN) for English-led non-commercial studies are the submission of an IRAS Form through the Health Research Authority (HRA) standard Integrated Research Application System (IRAS), and, submission via the Non-commercial Portfolio Application service (NPA) in the RDN's Central Portfolio Management System (CPMS). This provides the Portfolio Eligibility Team with the necessary information in CPMS to review the application for support from the RDN.

Non-commercial studies led by a Devolved Administration (DA) (i.e. the Chief Investigator or the lead R&D office is based in Scotland, Wales or Northern Ireland) but which have study site(s) recruiting in England are not automatically received into CPMS; either directly via the NPA or via IRAS. Therefore an email application is required. 

DA-led studies with English sites can make an email application  including those that are: 

• Open to recruitment

• Have an amendment to include English sites  

• Non-NHS studies 

This document supports the overarching guidance for NIHR RDN staff on non-commercial application routes, outlining the guidance and principles applied when receiving applications for support from the RDN studies that are led by a DA but have English sites. 

This document outlines:

• Which non-commercial DA-led studies are able to apply for support from the RDN through this route

• The guiding principles that are applied when these studies make an application for support from the RDN.

This document does not cover the commercial study application process nor does it capture the process for the study record management of studies in CPMS. 

To make an application for RDN support through the DA-led email application route, studies must meet the following criteria: 

1. The study must be led by a DA (i.e. the CI or the lead R&D office is based in either Scotland, Wales or Northern Ireland) and have participating sites in England.

These studies can be identified by checking Question 3a in the standard IRAS Form  ‘In which country of the UK will the lead NHS R&D office be located’ In new IRAS, for combined review studies, this information can be found by checking question 2 of section A. Administrative Details in the Project Study Information form.

a) Question 5c on the project filter in standard IRAS or Question 3c in new IRAS has been set to yes ‘You have indicated that your study has sites located in England. For the research sites located in England, do you wish for the study to be considered for NIHR Research Delivery Network (RDN) support and inclusion in the NIHR RDN Portfolio?'

The HRA will notify the Portfolio Eligibility Team by email when a study is received from a Devolved Administration (Scotland or Northern Ireland) which has indicated using Question 5c or 3c that it requires support from the RDN for its research sites located in England

Since the HRA and the Welsh Authorities have aligned their processes, notification of Welsh-led studies will come directly from Health and Care Research Wales (HCRW) rather than the HRA. 

b) An amendment has been submitted which includes English sites.

The HRA does not notify the Portfolio Eligibility Team of any amendments that they receive. As a result, these studies will have to be submitted via email to the Portfolio Eligibility Team (see point 3 below).

Evidence of the amendment to include English sites may be requested as part of the application for support from the RDN. This information will be used to allocate a lead RRDN. 

c) Studies that do not need, and therefore are not applying for, HRA Approval but have participating sites in England.

These non-commercial studies are not automatically received into CPMS; for DA-led studies an email application is required (see point 3 below).

d) DA-led studies that are already open to recruitment at one or more English sites

Applications for studies in their last six months of recruitment (or equivalent percentage for shorter studies) will not be considered. Studies with a short recruitment window (i.e. open for six months or less) must have at least half of their recruitment period left. This is to ensure that the RDN has enough time left to provide benefit to the study.  

These non-commercial studies are not automatically received into CPMS; for DA-led studies an email application is required.

1. A manual notification is required from the HRA or HCRW. Studies that are led by a DA are not automatically received into CPMS. Therefore a notification email is required to inform the Portfolio Eligibility Team that the study wishes to apply for support from the RDN in England.

2. A full document set must be available. On receipt of the email from the HRA or HCRW, the Portfolio Eligibility team will retrieve the following documents from the HRA Approval Portal:

• Evidence of all available funding (e.g. grant award letter, contract, etc.); and

• Study Protocol; and

• IRAS, REC or Project Study Information form (draft versions will not be reviewed)

If any of the documents are not available, the Portfolio Eligibility team will request that these are enabled in the HRA Approval Portal. 

Incomplete applications cannot be processed until the missing information is supplied. 

3. If the study is already open to recruitment or it has an amendment that includes the addition of English sites or it is taking place in a Non-NHS setting and does not require HRA Approval,  then an email application for support from the RDN for site(s) in England can be made in the following ways: 

• The researcher can make a direct application to the Portfolio Eligibility Team. The lead NHS Board, HCRW, NICRN or RRDN (as applicable) can support the researcher to make an application if required. 

• The lead NHS Board,  HCRW, NICRN or RRDN can make an application to the Portfolio Eligibility Team on behalf of the researcher following local discussions. 

For these study types there will be no change to the document set that is required for a valid application (available in point 2 above). Any additional information that is required to process the application will be requested as required. 

The Portfolio Eligibility Team will not be able to retrieve any documents for these studies via the HRA Approval Portal so they will need to be supplied with the email application.

Upon receipt of a valid email application for the above studies, the Portfolio Eligibility Team will send a notification of valid submission email to the Chief Investigator, Sponsor, DA contact(s), the RRDN if known and the relevant NHS Board, HCRW or NICRN as applicable to ensure that all relevant parties are aware that an application for support from the RDN is in progress. 

Whilst the Welsh and Northern Ireland administrations are supporting non-NHS research, the Scottish administration are not, therefore, there is potential for a study to be eligible in England but not in Scotland. In the instance of a Non-NHS study with a Scotland-based Chief Investigator, the RDN will support and manage the English sites only and will take ownership of the study as the lead administration. The RDN will only report on the English recruitment.

4. For studies coming through this route the CPMS study record will be created by the relevant Devolved Administration contact, unless a study is eligible in England but not eligible for support in the otherwise leading nation. In the latter cases, England will take ownership of the study as the Lead Administration and will support and manage the English sites only.

5. Assigning a lead RRDN in England should only be done once a complete application is received. As a general rule, this will be allocated to the RRDN with the most participating sites or one that has had prior involvement with the study. Alternatively, a study may be assigned to the RRDN with the fewest DA led studies to ensure that there is a fair split. Allocating the RRDN at this stage of the process will allow them to support any eligibility review related queries.

6. Once an eligibility decision has been made, the lead Devolved Administration and the Research Delivery Directorate will be notified. This ensures that they are aware of the study should they receive any queries about English sites in the future. 

7. The lead Devolved Administration will be responsible for completing the “Eligibility in England” section of the CPMS study record. English sites should only upload recruitment once the study has been deemed eligible for the RDN Portfolio in England.

API: Application Programming Interface

ARC: Applied Research Collaborations

CPMS: Central Portfolio Management System

CTIMP: Clinical Trials of Investigational Medicinal Products

DA: Devolved Administration 

HRA: Health Research Authority

IRAS: Integrated Research Application System 

MHRA: Medicines and Healthcare Products Regulatory Agency

NIHR: National Institute for Health and Care Research

NPA: Non-commercial Portfolio Application Service

PSRCs: Patient Safety Research Collaborations 

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre

RRDN: Regional Research Delivery Network

REC: Research Ethics Committee

Lynsey Evison

Portfolio Eligibility Facilitator

Email: lynsey.evision@nihr.ac.uk

To request a change to this document please contact portfolio.applications@nihr.ac.uk. Requests will be discussed on a 12 monthly basis within NIHR RDNCC Research Delivery and any resulting changes will be communicated alongside the reissued document.

Version number: 1.1

Effective from: 1 October 2024 (under review)