Winter 2023 Newsletter

In this issue

Programme Manager’s Update

It’s been another really busy period with outputs and activities from most of our groups, so do read below for updates on (amongst others!) our How to be a Good Chief Investigator events, shared audit work, planned webinars on platform trials, group national meetings and how the network has responded to national and international consultations.

As always, a sincere thank you to everyone who has provided contributions for the newsletter, and please do circulate it to your colleagues and clinical collaborators.

I hope everyone has a wonderful Christmas break and you and yours have a happy and healthy 2024!

Helen Evans
UKCRC Registered CTU Network Programme Manager

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Welcome to Kerry Hood

This autumn we were exceptionally pleased to welcome Kerry Hood to the post of Network Director.

Kerry Hood is currently Dean of Research & Innovation for the College of Biomedical & Life Sciences at Cardiff University

She has played a vital role with the UK network since its inception in 2007, firstly as Director of the South East Wales Trials Unit and then at the Centre for Trials Research.

Kerry’s research has centred on the conduct of complex clinical trials, mainly focusing on primary care, infections and learning disabilities.

Find out more here.

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Directors’ Meeting November 2023

In November 2023, we were very pleased to welcome delegates and speakers to Leeds.  This was the first Directors’ Meeting outside of London for many years and came about as a result of discussions at the meeting in May 2023 when people expressed an interest in trying different locations.

As well as being held in a new city, this meeting was also different because it was the first with our new Director, Kerry Hood (Cardiff University).  Kerry shared her vision for the future of the Network, including some of her immediate and longer-term priorities.  It was great to see how much enthusiasm there was for this from Directors

We had a number of other interesting sessions during the day including an update on activities across the Network from Helen Evans, a talk and Q&A from Rebecca Cosgriff (NHSE Transformation Directorate) on the latest developments on the data for R&D programme activity DigiTrials and the NHS Research SDE Network and a high-energy session on the use of Health Services Data and HDR UK’s Transforming Data for Trials plans by Matt Sydes (MRC CTU at UCL).

The final presentation of the morning session was by Sandra Eldridge and looked at the work of the INCLUDED (Promoting INCLUsivity through improving the practice and utility of Ethnicity Data collection in trials) project.  This NIHR CTU efficient studies funded work focused on producing initial recommendations for researchers on the collecting, handling and reporting ethnicity data in clinical trials.  Those recommendations, including a downloadable summary, can be viewed here: https://www.trialforge.org/trial-forge-centre/how-to-collect-ethnicity-data/.

After lunch, there was a very topical session on the NIHR Research Support Service (RSS) by Xi Ye (Programme Lead for Experimental Medicine at the NIHR).  This ended with a discussion on how the relationship between the RSS and CTUs could be promoted by:

  • Working together to capitalise on RSS and wider CTU’s expertise, capabilities and capacity.
  • Establishing collaborative working with CTUs.
  • Developing mechanisms of interaction and signposting that would be mutually beneficial.

This led neatly on to a roundtable discussion of some of the most pressing issues currently being faced by CTUs and how we could work together to address them.  Xi Ye was able to join one of the groups for this session and was therefore able to explore some of the Directors’ thoughts more thoroughly.

The final session of the day covered the HRA’s recent work to champion and support meaningful public involvement across health and social care research.  Jane Oakley, HRA Head of Public Involvement, discussed the support available for public involvement in Research Ethics Committee applications and the HRA’s Principles and Hallmarks of People-Centred Research amongst other activities.  More about People-Centred Research can be found here: https://www.hra.nhs.uk/planning-and-improving-research/best-practice/people-centred-clinical-research/.

Planning for the next Directors’ Meeting on 5 June 2024 is now in its very early stages.  If you would like to be involved in shaping the agenda, please contact the Secretariat on regctus@leeds.ac.uk.

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Network involvement in national activities

The Network continues to play an important role in ongoing conversations with national stakeholder on various themes and areas of work. This includes the DHSC, HRA, MHRA and others on the shape and direction of future national activities. It is great to see the recognition of the continuing value of CTUs and the Network voice.

DHSC’s Recovery, Resilience, and Growth (RRG) Programme

We continue to highlight where there may be inefficiencies for units and where CTUs are leading, in the way in decentralised and innovative trials, via both RRG Advisory Board meetings and regular informal meetings (below).

DHSC

The Network Director and Programme Manager have been meeting regularly with colleagues at the DHSC over the last 18 months and will continue to do so. These meetings have been a useful opportunity to showcase how the Network and Registered CTUs can help address some of the challenges that research faces. We look forward to providing some more detailed information on these discussions in future.

MHRA

The Network continues to maintain its strong relationships with the MRHA through regular meetings with our contacts, MHRA attendance at national Network meetings, and through their valuable advice and input on some of our most significant deliverables.

HRA

The Network now has increased representation on the HRA Partnerships board. This allows the CTU perspective to have greater weight during discussions there. Work continues with the HRA on reducing NHS R&D follow up after HRA approval and ways of creating efficiencies for NHS and CTUs there.

Our PPIE group are helping shape HRA guidance for involvement that will support the update to the clinical trials regulations.

NIHR Methodology Incubator

The Network continues to have involvement in to raise awareness of methods research, building capacity via the internships and training workstream and the statistics workstream.

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Training for Chief Investigators

How to be a good Chief Investigator for clinical trials

Do you know of a chief investigator who would like a refresher on how to interact with a clinical trials unit? Or one who’s about to work with you and want to get up to speed? Or perhaps someone initially considering working with a CTU?

Leeds, Nottingham and Cardiff CTUs are hosting workshops about exactly that, and will have expert keynotes, group work and host of other interesting activities, and we’re applying for CPD points too.

The workshops will include session on working with Trial Managers, the DM team and statisticians, the importance of PPI and EDI, maximising efficient trial conduct, and the experiences of first-time CIs amongst other useful content.

Registration for the in-person workshop in Leeds is now open. [Register Here]

The scheduled dates are as follows:

Leeds Clinical Trials Research Unit – 21 February 2024 – In person
Nottingham Clinical Trials Unit – 23 April 2024 – In person
Centre for Trials Research, Cardiff – Autumn 2024 – Online

For more information email regctus@leeds.ac.uk.

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QA Group Update

QA National Meeting

The national meeting was held in Birmingham in September, and was the first in-person session for a few years.  The agenda included an update on QA group and wider network activities, followed by a focus on eTMFs; we had an update from Rachel Heys from Bristol Trial Centre on the Mango project (Mango Study Management – Bristol Trials Centre), and a breakout session discussing the challenges and opportunities of eTMFs.

Lunch offered the opportunity to network and discuss posters that had been displayed throughout the day.  The afternoon included a Q&A session with the QA Ops group, followed by an MHRA update from Michelle Gabriel and a HRA update from Matt Rogerson. The response to the event was overwhelmingly positive with 94% of attendees rating the event as Excellent or Good.

Group Activities

We are hoping to recommence work on the shared audit project in the new year.  As part of this project we would like to produce some guidance, and templates for CTUs to use for internal audits and scope out the possibility of shared audits across CTUs.  You may remember discussions at the 2022 away day around this topic – unfortunately work has stalled due to unforeseen circumstances, but if you would like to be a part of the group taking this forward please contact the Secretariat on regctus@leeds.ac.uk.

The updated guidance for QA oversight of laboratories has been reviewed by the MHRA and will be published and circulated in the New Year.

We would also like to develop guidance for CTUs on running CTIMPs outside of secondary care, referring to existing resources and aiming to seek MHRA input prior to finalization.  More on this project will be circulated in due course.

The iPassport and Q-Pulse User Groups have now met on a number of occasions. Members are keen to hear from anyone who would be willing to demonstrate how they use a particular module or share a process that they follow. If you work in a Registered CTU and would like to be added to the mailing list(s) or share some of your work or experiences, please contact the Secretariat on regctus@leeds.ac.uk.

The QA group is feeding into other workstreams, notably via the Chairs’ group into work about post-trial data retention.  We are also planning to feed into the work of the Medical Devices working group which will be moving forward with a revised scope.

Changes to the group

Finally, the group itself is going through some changes.  Sadly, Chris Hayward (Exeter CTU) is stepping down from the group – we’d like to thank Chris for all his enormous contribution to QA activities over the years.  We received a large number of applications following our recent nominations exercise, so we were fortunately in a position to appoint three new members.  Thank you to everyone who applied.  It was great to see such a high level of interest.

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Data & IS Group (DISOG) Update

National Meeting

The DISOG National meeting was held face-to-face in Leeds on 19 October 2023. We were excited to host an informal networking session the evening before, in response to previous feedback from the group, and this gave a perfect opportunity to discuss key issues and make new connections in a relaxed setting.

The national meeting was very well attended with record numbers – we need a bigger venue next year! This is what we hoped for when we expanded the group remit to include representatives from Data Managers and IT/IS and encouraged units to send more than one attendee where they were able.

Topics covered included the protocol review process from a DM perspective (adopted at the MRC at UCL), audit trail review, an interactive workshop on reporting guidance, and ending the day hearing about the RECOVERY Trial.

We held another poster session to promote the amazing DM and IS/IT work undertaken across the network. Start thinking now about poster ideas for 2024!

Feedback received from the meeting has been overwhelmingly positive.

A huge thank you to Louise and Helen for all their hard work to make these meetings happen.

Outputs

The various DISOG subgroups have been hard at work developing guidance which we hope will be of use to all CTUs. Outputs on Data Archiving and CRF/eCRF development should be available to download from early in 2024. Watch this space.

Many thanks to everyone who has had a hand in developing these truly collaborative pieces of work. If you would like to get involved with some of the ongoing activities please contact the Secretariat on regctus@leeds.ac.uk.

Webinar Series

The next planned webinars will be focused on popular ‘off-the-shelf’ electronic data capture systems and will include OpenClinica, REDCap (community) and others. Thanks to everyone who has agreed to share their experiences.

Future talks planned for 2024 include one on platform studies (STAMPEDE2) and another on the experience of an MHRA study-specific inspection.

DISOG Membership update

In November 2023, Amanda Bravery left Imperial Clinical Trials Unit and therefore also stepped down as DISOG chair. She has been on the group since 2018 and Chair since 2022 and will be sorely missed. Tim Chater will be taking on the Chair position, with John Turgoose and Amanda Loban as Deputy Chairs. A nominations exercise has been opened to recruit two new members.

We are always looking for interesting presentations for our national meeting or webinar series – please let us know if you have a topic you wish to share.

– Tim Chater (Liverpool Clinical Trials Centre)

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Trial Management Group Update

Back in September 2023 the group members met for the first time in person to agree our new objectives for the year ahead. In addition to preparing for our next National Trial Managers Meeting, we are keen to gather experiences and share lessons to help with efficiencies on managing platform trials and gather case studies of challenges faced when undertaking publicly funded work in private hospitals. We will also continue to compliment work of the UKTMN particularly around trial management tools and training.

We are sad to say goodbye to Lucy Culliford (Bristol Trials Centre who has been our fantastic Chair since December 2022. Lucy will continue to support UKCRC activity particularly through the Policy Group. Jaclyn Bailey (Warwick CTU) has been appointed as our new Chair and looks forward to driving our renewed objectives forwards.

Denise Forshaw (Lancashire CTU) who was recently appointed as our Deputy Chair will also sadly be stepping down from the group as she will be leaving her unit shortly. We wish her all the best in her future endeavours.

We would like to thank everyone who recently applied to join the group. We were overwhelmed by the standard and unprecedented high volume of applications. We look forward to welcoming new members to the group in the next few weeks and to those who were not successful on this occasion, we hope to offer opportunities for engagement to support upcoming working groups to work on trial management solutions to benefit all.

– Jaclyn Bailey (Warwick CTU)

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Statistics Group Update

National Meeting

The Stats Group held its latest national meeting in Cambridge in November 2023. The event, which was hosted by the Papworth Trials Unit Collaboration, attracted over 70 delegates and speakers.

The day started with a deep dive into NOTACS (Nasal Oxygen Therapy After Cardiac Surgery), an adaptive trial with a novel patient-centred endpoint. Sofia Villar and Dominique Couturier (Papworth) took delegates through the development of the study including the running of the pilot phase, how the endpoint was chosen, the challenges of modelling and dealing with uncertainty in the design, and some of the important lessons learnt.

The roundtable session focused on two issues that can have a major impact on how successful CTUs are at recruiting and retaining statisticians: attracting applications from undergraduates and materials for training and development. Using some example documents that were currently in use around the Network delegates were invited to discuss how their own CTUs approached these issues and what lessons we could learn and share. The results of these discussions were captured electronically and will now be reviewed by the Group to identify future activities.

In the afternoon, there were a range of different presentations including preparing an application for a late phase trial with a Multi-Arm Multi-Stage (MAMS) design by Tom Burnett (University of Bath) & Royes Joseph (Keele Clinical Trials Unit), one on lessons learned from implementing an adaptive dose-escalation design in an early stage clinical trial by Suzie Cro & Rachel Phillips (Imperial CTU), and an interesting look at the use of Studies Within A Trial (SWATs) to improve evidence to inform participant recruitment and retention in randomised controlled trials by Adwoa Parker (York Trials Unit).

One of the most hotly anticipated sessions concerned the release of the Good Statistical Practice Training for Statisticians resources. The materials were developed by the Stats Ops Group and the work funded by the NIHR Clinical Trials Unit Efficient Trial Conduct Funding scheme. The suite of five training modules will be released via NIHR Learn and the Network website. An announcement will be made shortly.

PSI Careers Event 2023

The Network once again had a presence at the annual PSI Medical Statistics Careers Event. This year we were represented by Esther Herbert (Sheffield Clinical Trials Research Unit) who, as well as speaking to students during the exhibitor session, was the sole voice of academic trial statisticians on the Medical Statistics Careers Panel. Thank you, Esther!

We were really pleased to see that more CTUs are now attending this event as it represents a great chance to meet with students who are still deciding on their career path and increase their awareness of opportunities within the non-commercial clinical research. We encourage more CTUs to consider attending next year and nominate representatives to join the panel or give the ‘New Starter’ presentation. More information on this year’s event, including a breakdown of the range of students that attended, can be found here: www.psiweb.org/careers/psi-careers-event/event-details-23.

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Policy Group Update

The Policy Group continues to work with key national stakeholders such as the DoH, MHRA, HRA and UKRI MRC Regulatory Support Centre.  Most recently, we have increased our representation on the HRA’s Trial Set-up Partnership Board.  Contact with the MHRA Clinical Trials Unit is being re-established following the departure of Martin O’Kane and we hope to be able to play an important role in the development of the guidance that will support the new clinical trials regulations. 

Over the last few months, the group has provided a response on behalf of the Network to two consultations.  The first related to proposed changes to the ICH E6 (R3) Guideline on GCP.  In general, the Group felt that the new guidance represented a move towards greater pragmatism.   The second consultation was on WHO guidance for best practices for clinical trials. 

In September 2023, we were able to send a delegate to the National Outsourcing in Clinical Trials (OCT) Conference.  This was a very useful and interesting opportunity to understand the commercial research sector’s current issues and concerns, and learn more about where they intersected with those of the academic researchers. 

We are now in the process of reviewing the government’s full reply to the O’Shaughnessy Review and hope to be able to publish a short response piece on this early in the New Year. 

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Monitoring Group Update

One of the Group’s projects in 2023 has been running monitoring clinics every 3 months.  The invitations for these clinics are sent via the monitoring lead for each CTU.  However, any member of CTU staff can attend to propose any monitoring question or topic of discussion. In the last one of this current series, in October 2023, we ran a poll to find out if the attendees found the clinics useful and how frequently they wanted them to take place. 75% of the attendees wanted the clinics to continue every 3 months and we shall be announcing the 2024 dates soon.

The Monitoring Group is supporting a project led by PhD student Shiva Taheri to create a data monitoring plan template from UK expertise.  Thank you for your input so far. The first draft of the template is complete. If you want to take part in the instant reaction study, where we will record your first thoughts on perusing the template, or the pilot study where you use the template for one of your trials (probably alongside your CTU one) and take part in an interview afterwards, please contact Shiva at s.taheri@ucl.ac.uk Shiva’s second project is to look at the performance of metrics. If you have monitoring metrics data stored that you would be willing to share, please contact Shiva.

We are planning our annual meeting for June 2024 and will send a save-the-date in early February. We are also continuing our work on risk assessments and metrics.

Do contact the UKCRC network at rectus@leeds.ac.uk if you want to become actively involved in any of the monitoring projects.

– Sharon Love (MRC CTU at UCL)

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eTMF Usage in CTUs

At the national QA Meeting in September, there was a breakout discussion session to discuss eTMFs.  A summary of the main points from the discussion is presented here. 

It was clear from the discussions that there is an appetite within CTUs to move to an eTMF, however generally CTUs are either using SharePoint or a shared drive with paper TMFs.  Challenges mentioned were financing (off the shelf products are too expensive) and Sponsor buy in.  One CTU has set up an eTMF using the TMF Reference Model in an off the shelf document management system, another CTU has a bespoke web-based eTMF.  Bristol Trials Centre have NIHR CTU Support funding to develop an electronic study management system which includes an eTMF (the Mango project1) 

There were discussions around what functionality would be expected from an eTMF.  Expectations included esignatures, version control, an approval flow, ability to assign access rights, make documents read only, the ability to upload documents and an audit trail.  There were some useful discussions around the use of SharePoint as an eTMF, with input from Michelle Gabriel, MHRA GCP Inspector.    Michelle indicated that any document management system used to implement an eTMF would need to be risk assessed and decisions made around the functionality of the system and its compliance with regulatory requirements2. 

Implementation of eTMFs was discussed.  Generally, eTMFs have only been implemented for new trials with existing, active trials remaining as a paper TMF with an electronic repository.  Issues encountered include Sponsor refusal and buy-in from external collaborators, electronic archiving, IT support, job roles and allocation of job roles in off-the shelf systems.  Training was delivered in-house via training videos or Teams calls.  There was no experience of MHRA Inspections of eTMFs. 

1 Mango Study Management – Bristol Trials Centre 

2Guideline on the content, management and archiving of the clinical trial master file (europa.eu) 

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New PeRSEVERE Project Resources Launched

The UKCRC Registered CTU Network’s PeRSEVERE Project team has launched a dedicated website bringing together all its guidance on managing participation changes in clinical trials. 

PeRSEVERE focused on participants in clinical trials stopping, reducing or changing their level of involvement. 

The project aimed to address the question: how should we design and carry out clinical trials and other research, given that we know some participants will stop participating early? 

 PeRSEVERE was a collaborative effort, involving representatives of many different clinical trials units and different areas of expertise from across the CTU Network, as well as a patient group. 

 The team developed high-level principles to guide management of early end of participation in clinical trials and other research studies. Between May and August 2021, they ran a public consultation on the draft principles. The responses to the consultation were used to agree the final principles and associated explanatory guidance. 

 The PeRSEVERE principles, explanatory guidance, and related resources are all available at https://persevereprinciples.org. 

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Trials Methodology Research Partnership Update

TMRP Doctoral Training Partnership (DTP) Opportunities

We are currently advertising 36 projects in various areas including statistics, data analytics and informatics, computer science, health economics, qualitative methods, mixed-methods, clinical medicine and psychology. These are now open to apply for across our 12 partner institutions.

This is an excellent opportunity to undertake training for a PhD in trials methodology.

For the full list of projects including links to further information see https://mrctmrpdtp.com/current-opportunities/

Details on how to apply can be found here https://mrctmrpdtp.com/how-to-apply/

The closing date to apply is noon on 15 January 2024.

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UK Trial Managers’ Network Update

The UKTMN continues to grow – we now have over 1600 members, compared with 1400 in the summer issue of this newsletter! We continue to be committed to providing a range of support and resources for all of our members.

Our 25th Anniversary

On Thursday 9th November 2023, the UKTMN, based in the Nottingham Clinical Trials Unit, hosted a celebratory event to mark its 25th Anniversary.

Set up in 1998 and initially funded by the MRC, the UKTMN is now a vibrant network of around 1600 trial managers, around the UK, who play a vital role in the design and delivery of non-commercial, academic-led clinical trials in the UK.

Over 40 guests joined us for our celebration, including people who have played key roles in UKTMN’s journey, people who play leading roles in UK clinical research, and UKTMN members from around the UK. Photos and videos from the day can be found here.

Video: Working in clinical trial management

Over the past few months, we have been working away behind the scenes to develop a short video that showcases the trial management profession. By portraying the vital role that clinical trial management professionals play in the design, delivery and implementation of clinical trials, we hope this video helps the community get the recognition it clearly deserves. We also hope that our video reaches individuals who are not aware of clinical trial management as a career choice, so please share widely! We encourage Clinical Trial Units to consider using the video as a tool to help in the recruitment and retention of trial management staff. Please feel free to add links to the video (via our website) to your own websites.

You can access and download the video here.

Trial Manager of the Year Award 2023

This initiative is intended to increase awareness and recognition of the pivotal role trial management professionals play in the clinical trial community.

This year, we received 59 nominations; everyone who was nominated should be very proud of their contribution to clinical research, and we thank everyone for their detailed nominations.

Selection was very difficult with some excellent nominations to choose from.


This year, we have two joint winners: Zahra Madgwick (Senior Trial Manager, University of Oxford) and Bronwen Harry (Clinical Trial Coordinator, University of Cambridge). Well done Zahra and Bronwen!

We’re particularly thrilled that, this year, the TMOTY 2023 Award is being supported through NIHR Academy sponsorship, we will be awarding Zahra and Bronwen up to £500 each for a professional development activity of their choice.

Guide to Efficient Trial Management

The Guide to Efficient Trial Management has recently been updated and the 7th edition is now available at this link.

The Guide describes the process of managing clinical trials and gives an overview of the legal and operational trial management framework in the UK, providing hints, tips and references to external resources. It has been written for those new to trial management, who will find the Guide an essential reference tool; as well as for more experienced trial managers, who may wish to use the Guide as an aide memoire or as an induction tool for less experienced staff.

Professional Development case studies

We have launched a brand new series of trial management professional development career stories. Through this resource, we are hoping to capture a range of real-life career journeys that will provide the trial management community with a valuable insight into other people’s careers that we hope will help and inspire them on their own trial management journeys.

Click here to read our first professional development career stories.

Training

Since the July 2023 newsletter, we have delivered a training session on ‘Introduction to statistics for trial management professionals’. We have also hosted Member Webinars on: ‘Integrating behavioural science into clinical trials’, ‘The PrinciPIL study’ and ‘Recruiting to trials in an emergency setting’.

Please see our events page for courses that are currently taking bookings.

Commentary paper: ‘Time for a proper career pathway for clinical trial managers?’

We are delighted to share the news that our Commentary paper, ‘Time for a proper career pathway for clinical trial managers?’, has recently been published in Trials. You can access the paper, and a summary of the survey results, on our website here.

UKTMN Blog

One of UKTMN’s remits is to enable members to share their expertise across the community of trial managers. With this in mind, we have recently started a blog. We have over 1600 members and, collectively, a wealth of experience, so this forum is a great place to share knowledge! This is a great opportunity for trial managers to share the ‘soft experiences/intelligence’ in an informal way across the community. You may prefer this to writing an academic article, presenting a webinar or submitting an abstract to a conference, so please do consider submitting a short piece. You can read our latest blog posts here. If you’ve got an idea for a blog piece, please get in touch with us at uktmn@nottingham.ac.uk

Save the date: UKTMN 2024 Conference

We’re excited to announce the date of our Annual Conference, for UKTMN members, for next year as Tuesday, 4th June 2024. The conference will be held in Birmingham; more details to follow.

To find out more about the UKTMN

Email: uktmn@nottingham.ac.uk

Web: www.tmn.ac.uk

Do you use X? Then follow us for our latest news: @UKTMN

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NIHR CRN Coordinating Centre Update

Over 340,000 people register to Be Part of Research

Over 340,000 people have now signed up to the new UK-wide registry service from the NIHR’s Be Part of Research. The new service makes it easy for people to find and take part in suitable studies across the country. It also provides researchers with a large-scale registry of research-ready volunteers, offering the potential to accelerate recruitment to studies.

Volunteers can now sign up on the Be Part of Research website, using the NHS App, or using their NHS Login (England and Wales only). People are then sent information on studies that match their interests.

Visit Be Part of Research to find out how researchers can use the registry to recruit to their study.

New Portfolio Terms and Conditions

The Research Reset programme achieved the aim of ensuring 80% of studies on the NIHR CRN Portfolio are delivering to time and target. To ensure this remains the case, new Portfolio Terms and Conditions have been introduced.

All studies included on the NIHR CRN Portfolio must adhere to the Terms and Conditions in order to maintain access to NIHR Clinical Research Network support in England, and for continued inclusion on the NIHR CRN Portfolio. These Terms and Conditions apply at the point of acceptance onto the NIHR CRN Portfolio until a study closes to recruitment. The expected actions and requirements set out represent good portfolio management practice which supports the effective monitoring of the Portfolio and allocation of resources.

The study sponsor has overall responsibility for compliance with these Terms and Conditions. Sponsors may delegate the actions necessary to comply with them to suitably qualified parties (e.g. to the CTU) but retain overall responsibility for all aspects of the study and its delivery.

Further information on Portfolio Eligibility and the new Portfolio Terms and Conditions can be found on the NIHR website.

Increase in participation in NIHR Participant in Research Experience Survey

Every year, the NIHR Clinical Research Network (CRN) asks thousands of research participants to share their experiences of taking part in research. In the 2022/23 financial year, 30,705 adult participants completed the Participant in Research Experience Survey (PRES). A 21% increase from 2021/22. An executive summary of PRES survey can be viewed here.

Community Engagement in Health and Care Research training Evaluation

The CRN has developed and piloted a Community Engagement in Health and Care Research training to build community engagement capacity in the research workforce. An evaluation of the training pilot shows the impact of the training on staff knowledge and confidence, and plans to roll the training out in future.

Pre-Funding Research Feasibility Assessment Project

The Pre-Funding Research Feasibility Assessment Project was devised for the CRN health and care community to undertake a peer review of grant applications from the perspective of whether the clinical studies proposed are feasible to deliver in the current health and care environment. This pilot is in conjunction with the NIHR HTA and EME funding programmes as part of the Reset process.

The first, soft pilot was completed successfully on 5 studies, showcasing that the Research Feasibility Assessment can be conducted without disrupting the current peer review process. A further pilot will be conducted aligned with an HTA investigator led funding call to assess scalability of the process.

Pilot 2 was launched on the 10th November when the Stage 2 application period opened for the selected HTA investigator led research call. The successful study teams are requested to liaise with the Lead LCRNs to complete the Study Startup Delivery Tool (SSUDT), which will be used to generate a Research Feasibility Assessment report to support the delegated Specialty Lead to complete the reviews.

Contact: Tracy Harman, Head of Medical Directorate (tracy.harman@nihr.ac.uk)

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NIHR Academy Update

New NIHR opportunities for postdoctoral researchers

We currently have a number of brand new training and career development opportunities available for individuals at postdoctoral level. These awards are accessible to those from a variety of professions, and can provide excellent support to those wishing to further progress their research career.

Undergraduate Internship Programme

The Undergraduate Internship Programme is a new scheme which provides funding for early to mid-career researchers to host up to 3 interns. Interns will undertake a fully funded and flexible placement in the area or discipline they are interested in pursuing, whilst the applicant will have an opportunity to gain valuable supervisory and grant application experience.

Applications close 18 January 2024.

Development and Skills Enhancement Award

The DSE award is a funding opportunity aimed at supporting early to mid-career researchers in gaining specific skills and experience to underpin the next phase of their research career. The award provides funding to enable researchers to develop their skills in any area which will benefit their development as a researcher within NIHR’s remit.

Open for applications all year.

Senior Clinical and Practitioner Research Award

The SCPRA is a new opportunity which provides funding of up to 5 years for individuals at postdoctoral level to engage in research activities. The award offers applicants flexibility in that they can propose a broad range of research activities to support their career development, such as preparing for future funding applications, or undertaking relevant training.

Applications close 23 January 2024.

If you would like to further discuss these opportunities with a member of the NIHR Academy team, please contact academy@nihr.ac.uk.

To receive updates on funding opportunities, sign up to receive the NIHR Funding and Support newsletter.

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Training & Development Opportunities

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