October 2020 Newsletter
Date: 30th October 2020
Did you read?
If you missed it you can read the letter here
A statement released on behalf of the 4 nations contracting group on commercial and non-commercial site agreement (contract) variation at restart was also published.
Read the statement here
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.
Find all the guidance here
Jennifer Martin from the MHRA GCP team will be presenting more on the EU Transition at our non-commercial Sponsors symposium on 9th December.
NEW ABPI Report Autumn 2020 – How the UK can transform the clinical research environment
1. Restarting and restoring research across the UK and across all disease areas.
2. Transforming the UK clinical research environment with investment to increase levels of research beyond pre-COVID levels by:
- Optimising the processes for setting up and running clinical trials
- Building a workforce fit for the future with opportunities for all to be involved in research
- Harnessing the UK’s health data to support the efficient design, feasibility, recruitment and conduct of the full range of clinical trials
- Driving continuing high standards for transparency
- Creating a regulatory environment which supports innovation in life sciences
3. Ensuring that all patients have the opportunity to be involved and engaged with research.
4. Making research and innovation central to the UK’s trade strategy.”
Blog: What’s next for Health Research? Dr Janet Messer, Director Approvals HRA
Janet shares her reflections from two recent significant meetings held to reflect on how we can maximise the benefits and lessons learned from research during COVID-19, which despite all the progress made relies still on the value research plays to our organisations.
“The collective view of those at the meeting was that the most important and transformative intervention would be to make use of individual and organisational drivers to enable the behaviour change needed for clinical research to become business as usual across the health and care system.”
Janet will also be presenting at our non-Commercial Sponsors symposium to provide insights and updates from the HRA.
Did you know?
Our weekly coffee chats are feeding real time insight into the national system. Members of NIHR CRNCC and also the HRA attend our chats and the value has been acknowledged here in the fourth update from the NIHR on the implementation of the restart framework.
“Operationally, weekly contact via the Forum has allowed for sharing of best practices, supporting staff and collaboration on processes and practices”
Helen Lewis White, Research Operations Manager at North Bristol, continues to share national intelligence with the groups and feeds our operational R&D challenges into the national picture. Dr Maria Palmer, Director of the Forum sits on the National Vaccines Task Force.
New Forum credits now available for those who have paid for RDF20
We are of course hugely disappointed not to be able to hold a physical annual conference this year as well as having to postpone a face-to-face RDF21. However those who have registered and already paid for RDF20 will now be issued with our new credits to use on an exciting and developing virtual professional learning and development programme, a virtual RDF21 experience, and RDF22, when we do hope to see you all again.
Please do get in touch if there is something you would like the learning and development group to provide over the coming months.
All income from courses and events goes towards sustaining a viable and effective Forum for the future.
New ETC Virtual Round Table with Trudi Simmons
18th November 2020
3rd Annual Non-Commercial Sponsors Symposium
We are privileged to welcome the following speakers who have agreed to share their insights, expertise and experience. A full agenda will be published shortly.
Keynote Speakers announced are:
- Professor Martin Landray, Professor of Medicine and Epidemiology and Co-chief investigator of the RECOVERY Trial, University of Oxford will start the day sharing reflections from running the RECOVERY trial and the role quality by design has played in its success.
- Ann Meeker O’Connell, Vice President, Vertex Pharmaceuticals will be running an afternoon workshop on quality by design in association with RQA.
- Dr Natalie Banner, Lead for Understanding Patient Data, Wellcome Trust will also deliver a keynote presentation on learning from COVID plenary discussing the balance between Trust and the need for patient data for research.
- Jennifer Martin, Expert GCP Inspector, MHRA
- Dr Janet Messer and Juliet Tizzard, HRA
- Alastair Nicholson, HRA & colleagues from the MRC
- Karen Melham, Oxford Sponsorship team
- NoCLOR Sponsorship team
- Lynn Laidlaw, Patient & Public Involvement Partner and Professor Shaun Treweek, Chair in Health Services Research, University of Aberdeen
- Sharon Love, UCL CTU
- Learning from COVID-19
- MHRA regulatory updates – EU transition and updates from the MHRA GCP team
- Latest from an HRA perpective
- New information governance work undertaken in discussion with the ICO
- Data protection and Sponsorship
- Learning from the Oxford Sponsorship team – insights on how to maintain quality of sponsor and other oversight while fast tracking Covid related research
- Sponsorship in a Mental Health and the community – experience and expertise in sponsoring mental health studies and studies across community settings.
- Whose participant information leaflet is it anyway?
- UKCRCC monitoring workstream and lessons learned on Monitoring and QA during COVID
Head of Research and Development at NoCLOR Angela Williams said:
All presentations will be recorded and available for 12 months after the symposium and there will be many opportunities to discuss Sponsorship practice with peers.
REFLECT AND CONNECT
25-29 January 2021
- Professor Jean White, Chief Nursing Officer, Wales
- Jim Elliott, Public Involvement Lead, HRA
- Janet Messer, Director of Approvals Service, HRA
- Emma Lowe, DHSC
- William Van T’Hoff, NIHR and NHS R&D Forum
- Philip Smith UKRD/RDFORUM Finance Group
- Recognising the contribution and impact of the nurse and midwifery research workforce throughout Covid-19
- The future of R&D in the UK
- Public Involvement in a Public Health Emergency
- Cost of COVID
- The future of industry research and rebuilding the charity sector
- Stop, start, restart
This course is designed for any role at all levels when new to a health care R&D department. The course might also be of interest to colleagues in industry, academia and the third sector that would like to better understand managing NHS Research or just for those who need to keep updated. Updated material includes a whole new look package of essentials for anyone looking for a complete overview of NHS R&D management.
This interactive course is a great opportunity to connect with peers and work through everyday challenges. A workbook will be sent to your office or home address prior to the course start date and course certificates are emailed to all delegates on completion.
Archiving Masterclass – new date
20th January 2021
This Archiving Master Class has been developed to support Research management teams with their processes for archiving and is for anyone who has responsibility for archiving research in their organisation. Whether you are a named archivist or part of a team with delegated responsibility we hope that you will find this course useful.
This one-day interactive course is a great opportunity to connect with peers and work through everyday challenges. A workbook will be sent to your office or home address prior to the course start date and course certificates are emailed to all delegates on completion.
Calls from the community
We are keen to hear from anyone who is committed to supporting the Forum and would welcome interest from across health and care. We would particularly like to hear from those in community, mental health or non-traditional organisations.
Joint UK Research Finance – task and finish group to produce guidance on aspects of research finance
If you would like to take part, please click here for the contact details of the lead for the appropriate domain.
The DataLab at the University of Oxford is conducting a study of how UK clinical research institutions approach and operationalise clinical trials transparency policies. They are currently soliciting interest from stakeholders at UK Universities and NHS R&D departments who would like to share their experiences in this area.
Participation would consist of an audio-recorded online interview session. Please note, your participation in this study would be confidential and any use of information you provide will be kept anonymous. Access the participant information sheet here.
If you are interested in the study or would like to learn more, please contact Nicholas DeVito at: email@example.com.
As part of how the CQC are developing their next strategy they are sharing their latest thinking on a range of key areas. We feel that research is notably missing from the strategy so far but please let us know if you have more to add. Send you thoughts on the outline strategy to firstname.lastname@example.org or feed into the CQC website directly.
The NIHR has issued guidance to protect both COVID-19 and non-COVID-19 research during a ‘second wave’ of high COVID-19 activity.
NIHR shares fourth update on implementation of the Restart Framework
This update was shared on 16 October and includes second wave guidance, the latest CRN data, funding contract variations and study resilience and working with partner organisations.
Refreshed Restarting research page on NIHR website
This page has been refreshed and now includes links to previous updates, examples of best practice and resources to help reassure patients that it’s safe to get involved in research, like this short animation.
Winner of the RCNi Excellence in Cancer Research Nursing
Many congratulations to Ben Hood from Newcastle upon Tyne Hospitals NHS Foundation Trust who won the RCNi Excellence in Cancer Research Nursing Awards! Ben, developed a pilot project to highlight the role of clinical research nurses in cancer services that could be used across the UK. He delivered education sessions to 2,000 students in north east England and is currently developing this work into an E-learning resource for undergraduate nurses in partnership with the National Institute for Health Research. Highlighting the role of clinical research nurses has never been more important especially as we celebrate the Year of The Nurse and Midwife during a global pandemic. For more info contact: Dr Sharon Barrett Associate Director of Nursing, CRNCC email@example.com
New look NIHR Learn
NIHR CRN CC are excited to share the news that we will soon be launching a new look and feel for NIHR Learn – our online learning platform that supports over 45000 colleagues across the research landscape every year. The new theme will be going live later this autumn and will provide learners with a fresh and intuitive look and feel, easy access to your learning record and links to recommended learning based on current priorities and previous learning history. This first launch is part of an ongoing programme of development that will also soon see us introducing social functionality that will enable you to rate, comment and recommend learning resources to colleagues.
As part of our commitment to collecting accurate and useful data we will also be encouraging all users to check and update their profile information, such as their role in research and related LCRN, and we will be looking at how we can best use this information alongside other workforce intelligence to understand and support our people network. Further comms about these coming changes will be released over the next few weeks.
A reminder that the DeLVE events and webinars calendar on NIHR Learn is being regularly updated with details of internal and external webinars and training. If you are aware of any forthcoming events that would be useful to include, please can you forward these to firstname.lastname@example.org.
From early November a Portfolio Application Form (PAF) will no longer be required to apply for NIHR Clinical Research Network (CRN) support.
If you are applying for NIHR CRN support, and have not already done so, you are advised to contact your local Clinical Research Network (LCRN) as soon as possible to access the NIHR CRN’s Early Contact and Engagement Service.
EU Regulation 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)
EU policy statement – Scotland
MHRA joins up with Australia, Canada, Singapore and Switzerland Regulators
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
Read more here
Radiation Assurance is Expanding
From Wednesday 30 September 2020, the HRA Radiation Assurance process (all nations) now:
- accepts all studies involving general radiology
- allows HRA registered reviewers (MPEs and CREs) to register to undertake reviews independently (as well as through their employer) if they choose to
- enabling commercial sponsors to use their choice of Radiation Reviewers and their agreed timelines through the self-managed route
This means you can now benefit from Radiation Assurance for all studies involving general radiology, as well as all radiation modalities for oncology, cardiology, rheumatology and neurology.
Read more here
Update on Health and Social Care Research Projects for Educational Purposes
A pause on health and social care research projects for educational purposes has been extended until September 2021.
Read more on the the HRA updated statement and how students might otherwise gain experience of health and social care research
New resources in REX this month
The NHS R&D Forum Resource Exchange (REX) is a searchable, categorised set of resources and case studies submitted by members of the Forum community.
You will find the following new resources in REX this month.
- The search for a Vaccine – podcast series
- Our NHS People REACT MH Conversation Training
- UKCRF Network guidance and tools