CSP091: NIHR CRN Urgent Public Health Research Response

This document provides guidance for responding to the declaration of an urgent public health emergency across the NIHR Clinical Research Network (CRN), including study identification and prioritisation, expedited set-up, performance oversight, study delivery, data visualisation, communications, and reporting.  It outlines the roles of the Local Clinical Research Networks (LCRNs) and  NIHR CRN Coordinating Centre (NIHR CRNCC)  in ensuring the Urgent Public Health (UPH) portfolio is delivered. This document may be used alongside a situation-specific Roles and Responsibilities Document. 

This document focuses on NIHR CRN activities for English-led studies.  Linkage with Devolved Administration (DA) colleagues is key to enabling a UK-wide approach to UPH portfolio delivery.  Implementation of this guidance should reflect the response level required, the scale of the urgent public health emergency, and the number of studies requiring set-up and delivery.

The need for activation of the response to an urgent public health emergency (referred to as the UPH Research Response), and the scale of the response required,  will be identified by the Chief Medical Officer (CMO) of England. 

This will be communicated to the NIHR CRN Chief Operating Officer (COO) and the Chief Executive Officer (CEO) (or the NIHR CRN Research Delivery Director or CRN Medical Director in the COO’s absence)  by a designated contact at the Department of Health and Social Care (DHSC).

• The NIHR CRNCC will acknowledge this communication by email within one hour. 

• If further information is required relating to the announcement of the urgent public health emergency, and the commencement of the expedited research process, the DHSC Research and Delivery Directorate shall be contacted in the usual way.

• Should communication not be received confirming activation of the UPH Research Response, a member of the NIHR CRN CC Executive Board may reach out to the DHSC Research and Delivery Directorate for confirmation. 

How this information is cascaded is at the discretion of the NIHR CRNCC CEO. 

The NIHR CRN CC will establish a cross-directorate UPH Review Group and an Operational Oversight Group to lead activities to ensure NIHR CRN National Portfolio UPH research studies are set up and delivered in a timely fashion. The groups will be established as soon as DHSC requests expedited UPH research and will be chaired by the Medical Director.  

The Operational Oversight Group will maintain portfolio performance oversight. This group should comprise NIHR CRNCC Research Delivery Team representatives and members of the UPH Review Group panel and will discuss ongoing performance, identified issues, and issues for escalation. Meeting frequency for this group is dependent on the size of the UPH Portfolio. 

The Operational Oversight Group will rapidly establish systems to identify UPH studies, e.g.: 

• An online application process, for studies for consideration to be submitted through.

• Systems for study submission triage and review by the UPH Review Group. 

• Criteria for determining whether submissions should be assigned UPH status.  

• Communication of review outcomes to applicants, including instructions on next steps, following the decision of the UPH Review Group. 

The UPH Review Group will review applications for UPH status consideration, assessing submitted documents against agreed criteria. The group will also assign Clinical Links to UPH studies (see Section 2.1) to provide oversight and support. Situation-specific guidance on the role of this group shall be outlined in a specific UPH Group Terms of Reference document. 

This group will have a large and varied membership,  and will include (but not be limited to):

• CRN Coordinating Centre representatives:

  • • National Research Delivery Lead(s)

    • Medical Directorate personnel

    • Business Development and Marketing personnel 

    • Workforce Learning and Organisation Development personnel 

• Clinical Trials Methodologists and CTU representatives

• NIHR Infrastructure representatives 

• Specialty representative(s) from all Specialties deemed relevant. 

• Representatives from Lead or participating LCRNs, where appropriate. 

• Study team representatives; as and when required

• Representatives from DAs. 

• PPIE representatives (including PPI team support if required) 

• NHS England / NHS Digital / HDRUK (as required)

• Government Task Forces / DHSC / UK Health Security Agency (as required)  

In addition, studies on the portfolio with a “suspended” status may be reopened in response to an urgent public health emergency. Following notification of reopening, these studies will pass through the UPH review processes as outlined above. Studies already included in the portfolio may be repurposed to meet the research needs of urgent public health emergencies. 

Following notification by the UPH Review Group  that a study will re-purpose, a meeting should be established as soon as possible with the study team or company contact, Lead LCRN, and NIHR CRNCC Research Delivery team to discuss the changes to the existing study protocol. This guidance should be followed in line with the requirements of the study team or company contact. Such studies should be subject to the same oversight as all new UPH studies.

A Clinical Link should be assigned to all studies deemed UPH. The role of the Clinical Link is to support activities throughout the lifecycle of the study by offering clinical expertise; specific support required will be based on the needs of the individual study. 

The role could include, but is not limited to, the following activities: 

• Be the liaison between the UPH Review Group,  RDD, Lead LCRN and CI/study team

• Provide clinical support and advice during study set up, such as:

  • Trouble-shoot issues of set up or delivery

  • Providing relevant clinical intelligence

  • Provide on-going reporting to the UPH Review Group on study progress

  • Provide high level clinical input to study performance monitoring and delivery

  • Act as a point of escalation to support ongoing communications about the study

In the event of an urgent public health emergency, the NIHR CRN must respond quickly to initiate, deliver and report on related research studies . Forward planning is key to achieving this. LCRNs should consider and ensure the following:

• That there are business continuity processes  including covering major staff absence, and prioritisation of business activities.

• That there are plans in place for the reallocation of resource, including team members, nursing staff, pharmacy and consumables

• That the proportion of Network-supported staff who can engage in UPH research  is maximised, identifying the skills required and keeping a log of available staff (as clinical   staff are likely to be heavily engaged in patient care). 

• That clear methods of communication have been established including communicating with study teams, CRN staff, NHS Trusts and Integrated Care Boards (ICBs) formerly Clinical Commissioning Groups (CCGs). 

• That all CRN staff have contact details for key personnel and that this information is updated regularly

• That there is an awareness of the UPH studies in the area amongst Trusts, Network staff, research communities and Local Clinical Research Specialty Leads. Co-enrolment strategies for current  and new studies that might be expedited should be considered.

LCRNs should work with Trusts and ICBs to ensure that they are aware of their UPH Plans and that these link with the Network’s plans. Plans should be considered at a regional level with collaboration between Specialties. Processes should be in place to track study progress and identify problems with study set-up and conduct.  Reporting and escalation procedures will be undertaken rapidly and so current systems may need to be adapted to allow for this.

The UPH Review Group will notify the NIHR CRNCC Research Delivery team of studies designated as UPH research. The NIHR CRNCC will cascade study details to CRN colleagues via organisation-wide bulletins (Section 5.2). The NIHR CRNCC Research Delivery Senior Management Team may assign an individual or group to initiate the set-up of the study. It will be the responsibility of this individual or group to disseminate relevant information about this study to the wider NIHR CRN CC Research Delivery team. 

Consideration should be given at this point to who will perform the Performance Review Lead (PRL) Role for the study (Section 4). Support offered for study set-up, delivery, and monitoring  is performed at a CRN-level, in line with the Performance and Operating Framework.

The NIHR CRNCC Research Delivery team will review the portfolio to check if a submission has already been received  for the study.  If the IRAS form or commercial submission has been received and has yet to be reviewed, this will be assessed as quickly as possible to confirm eligibility or feasibility. If there is no study record already, then:

• non-commercial studies: the study team will be asked, as a matter of priority, to supply the IRAS form to the national Eligibility team, who will confirm the study as eligible within 2 hours of receipt.  It is assumed that these studies have been deemed eligible for NIHR CRN support via the review process.   

• commercial studies: the study sponsor or managing organisation will be contacted by a member of the national Feasibility team to discuss and confirm requirements for CRN Services prior to making an application.  Once submitted, the application will be reviewed and eligibility confirmed as soon as possible by the Feasibility team.

Confirmation of review will be sent to the relevant NIHR CRNCC Research Delivery portfolio inbox to permit study record creation. The Research Delivery Team will initialise the study record within four hours of submission receipt. Additional information required to complete the record will be collected by the Research Delivery Team and agreed with the Sponsor or study team in a phone call. For studies with existing records, the record should be updated and a note added to the record to confirm the date the study was designated UPH as per Section 2.

A meeting should be arranged between the PRL (Lead LCRN and/or NIHR CRN CC Research Delivery Team),  study team/sponsor, Clinical Link, and any other relevant team members (including DA colleagues), and should be held at a frequency agreed by all parties. This meeting is a space in which to share information relating to:

• Study set-up requirements. 

• Potential barriers to study delivery. 

• Assistance required by, and available from, the CRN. 

• Timelines for study submission.  

• Other relevant information to support successful set-up and performance monitoring. 

Additional meetings may be arranged with other parties and stakeholders, for example the DHSC, NIHR CRN CC colleagues, Specialty Leads, Clinical Links, and DA colleagues, as required, to support study set-up. 

To enable rapid study set-and support data sharing, supporting documentation may be developed by the PRL and shared with the study team, company, and relevant colleagues. These documents shall be collated centrally and hosted on the RDMC Hub, and may include:

• A FAQ document where enquiries may be collated and answered by the study team. 

• A centralised contact list of all colleagues and stakeholders involved in the study. 

• Meeting agenda documents 

• Other relevant documents, e.g. site set-up registers or trackers. 

• If deemed appropriate, study documents may also be stored centrally. 

For new UPH studies, sites and Principal Investigators (PIs) may need to be identified. A call may be held between the PRL (NIHR CRN CC Research Delivery/Lead LCRN), the study team, and DA colleagues, to discuss site requirements and agree on an Expression of Interest form. 

Non-commercial studies: This will be managed jointly by the NIHR CRN CC Research Delivery Team and the Lead LCRN. This activity will be expedited with direction from the CRNCC. The Lead LCRN will:

• liaise with all LCRNs with potential study sites via their Generic Study Support Service email accounts, to accelerate study set-up.  

• work with participating LCRNs to  link with the relevant expertise to support expedited set-up for any site type, including for example primary care and community settings. 

• support participating LCRNs with potential study sites to identify a contact to work with the local PI, or link with their Partner Organisation to identify a local PI or collaborator where required. 

• document all sites wishing to take part, and identify named contacts at those sites, and share the list with the NIHR CRN CC.

Commercial studies: Sites will be identified via the NIHR CRNCC Research Delivery site identification service offering, which will be expedited and provided within 7 working days. The study sponsor or managing organisation must contact the national Feasibility Team to confirm requirements for study sites prior application. If the Lead LCRN are in contact with the Sponsor/CRO/Study Team, the LCRN should signpost them to make a commercial submission to the Research Delivery Team, if not already done.  LCRNs will facilitate this by contacting potential sites and completing the site service form, as needed.  

All studies must be allocated a Lead LCRN. The team performing the PRL role for UPH studies will have been agreed shortly after the identification of the study (Section 3). The PRL may be a representative from the NIHR CRNCC, or the Lead LCRN.   

The role should be performed in line with the Performance Monitoring SOP. In brief, the PRL will prioritise performance monitoring activities to support successful, and timely, set-up of study sites and recruitment of the study sample size. This will be achieved by:

• Monitoring set-up timelines supported by escalation of issues to minimise delays.

• Regular meetings between the PRL,  participating LCRNs, and the study team/company.

• Identifying performance barriers  via meetings, and escalating these as needed.¹  

• Using visualisation processes to proactively review performance on an ongoing basis.

The PRL will also  contribute to reporting activities in liaison with the NIHR CRNCC Research Delivery Team, and link with/report to the UPH Review Group and/or the Operational Oversight Group  regarding study performance.  

Under urgent public health emergency conditions, consideration should be given to the frequency of performance monitoring activities, meetings, and reporting to ensure sufficient support is provided. This may be more frequent than outlined in the SOP, may fluctuate over the life or the study, and should reflect the level of support required by the study. 

In addition, the PRL will be responsible for study record management, and should update the study record in line with the  Study Record Management SOP. This will include:

• Reviewing the sample size on a regular basis to ensure it reflects the latest position. 

• Maintaining the accuracy of the study record via regular liaison with the study team. 

Co-enrolment should be considered across the whole portfolio of UPH studies, to ensure wide patient access to research and equitable access of studies to relevant populations. A datagrid outlining potential co-enrollment opportunities should be established and regularly updated.

Recruitment reporting is used to support ongoing performance monitoring of studies on the CRN portfolio. Collection of this data will be the role of the PRL. The effort required by researchers and companies to provide research activity data  will be taken into consideration in deciding on reporting frequency; should this need to be daily or weekly, at the request of DHSC to inform their activities, systems should be considered to support this. 

Processes may be required to collect additional information to support DHSC activities. This may include participant ethnicity, age, sex or gender, and multimorbidity data. If not in place, consideration should be given to how this data will be collected on a regular basis.

To monitor the recruitment and performance of repurposed/existing  studies, consideration must be given to how recruitment data is collected, and how sample size targets are rendered. A system should be implemented by which prior recruitment and recruitment throughout the urgent public health emergency can be separated and independently tracked. A list of these studies should be generated, to be maintained by the NIHR CRNCC.  

Study performance issues will be escalated to the UPH Review Group,  via linkage with the designated Clinical Link,  NIHR CRNCC Research Delivery Team and/or Lead LCRN, or Operational Oversight Group,  where appropriate. Please see Section 2.1 for further details. 

¹ After study opening, meetings should be established involving participating LCRNs, site teams, and DA colleagues, to facilitate best practice sharing and troubleshooting. Meetings should be minuted, and updates shared with all attendees as soon as possible to ensure timely support. 

Close linkage with the NIHR CRNCC Communications team is vital to ensure dissemination of information. A process for sharing information should be established as soon as possible after the declaration of an urgent public health emergency, with consideration given to the  visibility of UPH studies and associated communications. This shall be agreed in liaison with the CRN CC Research Delivery Team, Operational Oversight Group, and Communications Teams. 

To streamline study monitoring, a single point of contact email address may be established by the NIHR CRN CC. This may be an existing Portfolio email inbox or new email account. Consideration should be given to who will maintain oversight of the inbox used and any additional triaging processes required. LCRNs may be guided to establish analogous single point of contact email addresses and/or telephone numbers if appropriate. 

Regular communication shall be maintained across the CRN. This may include:

• An agenda point at RDMC meetings to share updates.

• The use of the RDMC Hub area to share information, documents and updates.

• The establishment of a defined Hub area for sharing UPH study intelligence. 

• Announcement of newly identified UPH studies, and other key information relevant to the UPH portfolio, via organisation-wide bulletins, as required.

• Sharing information related to study updates and initiatives via CRN-wide bulletins. 

• Use of the NIHR website, to host study information and share internal announcements. 

If sharing UPHR study details on external-facing platforms to support visibility of the UPH research response, a process to cascade information should be agreed between NIHR CRNCC Research Delivery and the Communications Team. Consideration should be given to the level of information that can be shared with external parties, and the maintenance of externally facing platforms to ensure data is kept up to date. 

Following the announcement of an urgent public health emergency, consideration should be given to data visualisation methods to support the monitoring of study performance, portfolio delivery, and the generation of reports for circulation to internal and external stakeholders. Early communication with the National Business Intelligence team will be required to:

• Agree the data points to be collected and presented in the data visualisation system. 

• Agree the method of identifying and flagging studies contributing to the UPH Research Response, to allow the relevant studies to be visible in the platform.  

• Confirm data presentation formats and accessibility requirements of the platform.  

• Consider how involvement of “re-purposed” or existing studies in the UPH Research Response should be denoted to support accurate reporting.

Elements of this data visualisation may include, but not be limited to:

• Tools with which to track recruitment over time. 

• Tools to assess case rates by geographical area to support recruitment targeting. 

• Dashboards (e.g ODP) to quantify recruitment against known case rates. 

• The ability to automatically generate reports for performance monitoring purposes.

• Linkage to data feeds from Government agencies to contextualise study data. 

Portfolio performance reports will need to be shared with internal and external stakeholders throughout the UPH Research Response. The NIHR CRNCC Executive and Senior Leadership Team should liaise with relevant groups and individuals to establish reporting lines and timeframes. This may include, but not be limited to:

• The Department of Health and Social Care

• The UPH Review Group

• The Chief Medical Officer of England

The requirements of these reports, and who should generate them within the NIHR CRNCC, should be agreed. This may be the Communications team, the Business Intelligence team, or the NIHR CRNCC Research Delivery team, as appropriate.

CCG: Clinical Commissioning Group 

CEO: Chief Executive Officer

CI: Chief Investigator

COO: Chief Operating Officer

CMO: Chief Medical Officer

CRN: Clinical Research Network

CRNCC: Clinical Research Network Coordinating Centre

CTU: Clinical Trials Unit

DA: Devolved Administrations

DHSC: Department of Health and Social Care

HDRUK: Health Data Research UK

ICBs: Integrated Care Boards

IRAS: Integrated Research Application System 

LCRN: Local Clinical Research Network

ODP: Open Data Platform

PI: Principal Investigator

PPIE: Patient, Public Involvement and Engagement

PRL: Performance Review Lead

RDD: Research Delivery Directorate

RDMC: Research Delivery Management Community 

SOP: Standard Operating Procedure

UPH: Urgent Public Health

Version number: 1.0 

Effective from date: January 2023