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March Newsletter

Date: 27 March 2018

Welcome to our March News

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2018 Conference News

Conference 14th & 15th May 2018. Celtic Manor, Newport Wales Another new addition to the programme are the Fringe Events. The Fringe Events allow delegates to spend some time visiting the Exhibitors, Viewing the Posters or electing to attend one of the following Open Sessions. Please note that to take part in the Open Sessions you must arrive promptly at the start of the session. They will be taking place on Monday from 16:50-18:00.

Exhibitors and Posters will remain open on the Caernarfon Suite level. And the following Open Sessions will take place on the Conference Level 1:

  • Developing Clinical Research Teams
  • Integrating research indicators into CQC assessments of Trusts
  • Evidence For Commissioning
  • Improving non-commercial research sponsorship

For the updated programme see here

With six weeks to go we are looking forward to welcoming over 500 people to Celtic Manor. And if you haven’t booked yet, it isn’t too late to join us for the best NHS R&D Forum Conference to date.

Book now

Training

Our new learning & development oversight group have some exciting developments for the coming year and beyond, and we can share some of these with you at the Conference in May.

Forum courses currently open for bookings this quarter are:

Data Management for Research in a Healthcare Setting: A Master Class

Only a few places remaining…..

The NHS R&D Forum have partnered with the Association of Clinical Data Management (ACDM) to provide this comprehensive one-day expert master class of interest to all research management teams.

This is essential training for anyone in a Sponsor R&D office or clinical trials unit and individuals with responsibility for clinical research data oversight. Learn to develop a data management plan and understand how to minimize risks to study data. More information and learning outcomes here

Regulatory Inspection Ready, 14th June, London

This is a practical course delivered by experienced NHS R&D managers who work in the NHS and have direct experience of managing regulatory inspection in their organisations. The course is designed for all staff involved in research management or for those who want to learn more about the Inspection proces and that maybe subject to regulatory inspection. More information here

New dates for all our courses coming up over the year are to follow

Forum Roundup

A few places are available for the NEW Forum GDPR work stream and reference group.

We have a few places remaining following our call last month for membership of the new Forum GDPR work stream and expert reference group. Meetings will be held by teleconference with one face-to-face meeting on the 26th April in London, with support from the MRC regulatory support centre and HRA policy & training teams. If you would like to take part contact kate.greenwood@rdforum.org.uk and read more about the work-stream here

Adding Value to Research through research management, support & leadership.

A multi-stakeholder meeting was held on the 6th March with representation from across the Forum and UK partners including the HRA, Health & care Research Wales, NHS England, AMRC, Northern Ireland. A brief summary of the day is here with further information to follow

New Forum non-commercial sponsorship work stream

The Research Management Working Group is pleased to launch a new subgroup focusing on improving research sponsorship for all non-commercial organisations. This group will be hosting one of the Fringe events at our conference in May to help identify priorities and hot topics for the year ahead. If you are interested in becoming a member of this work stream please contact kate.greenwood@rdforum.org.uk

Have your say

Developing new guidance for research management teams: Service Users and Carers as Co-Applicants, Project Team Members and Co-researchers:

Please send your views on the new briefing paper from the Forum Service User and Carer Working Group and in particular how this guidance might be amended to become most useful to R&D management teams as well as Service Users and Carers.This paper explores all the research management considerations for when service users and carers act as co-applicants, project team members and co-researchers so please let us know

Read the paper and answer some quick questions to help take this work forward.

A Forum voice continuing to influence and shape health R&D

We are pleased to note the launch of two new resources into which the Forum has fed views from research departments across the UK. These are the new National PPI standards and guidance from NHS England on the continuing funding of treatment after a clinical trial. You can read our consultation responses and some have indeed been considered in the final versions.

The strategy and leadership groups maintains an active log of all areas of strategic interest to health research management & leadership in order to support our voice in the community.

We think this shows the Forum continues to shape and influence on hot topics relevant to NHS R&D so please keep your thoughts and views coming.

 Around the Forum

Congratulations to all newly confirmed test beds supporting the new Public involvement standards.

Call for good KPI and board reporting templates

Do you have an easy-to-use or well-established template for collecting KPIS and reporting to your board?

Members of the strategy and leadership working group would like examples of templates or tools that work well for you in your organisation. Please share what you can by sending them to kate.greenwood@rdforum.org.uk

NIHR Portfolio activity: is it having a positive wider impact on a NHS trust’s performance? A new study published from Cumbria Partnership NHS Foundation Trust

Dr Leon Jonker & Dr Stacey Fisher, CRN funded staff from Cumbria Partnership NHS Foundation Trust, have published a new paper highlighting a link between conducting clinical interventional research & quality-related outcome measures. Their study builds on existing evidence but also shows novel outcomes which are that there is a significant positive association between NIHR-adopted interventional clinical research activity and both a Trust’s CQC rating and its mortality rates.” Read their blog to find out more

New Resources

We have a good number of new resources into REX this month! Please keep sending them in. You can upload them directly or send to info@rdforum.org.uk

  • School for Change Agents: Module 1-x live webinar catch up
  • New GDPR guidance note 3: MRC regulatory support centre
  • Trial Forge Guidance 1: What is a Study Within A Trial (SWAT)?
  • Understanding patient data #datasaveslives: A suite of new animations to share with patients about how patient data is used and shared for patient benefit
  • New versions of the mCTA and CRO-mCTA for commercially sponsored research in the NHS
  • NIHR podcast: MHRA GCP inspections with Jason Wakelin-Smith
  • NHSE commissioning policy. Continuing funding after completion of a clinical trial
  • Early career Dementia researchers network, toolkit & resources for dementia research and researchers
  • GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research
  • CLARCH East of England: Guidance for researchers on PPI feedback
  • Assessing the impact of research. A model for assessment of research impact, a framework for tracking diffusion of research outputs and activities to locate indicators that demonstrate evidence of biomedical research
  • Knowledge mobilisation literature
  • NEW MHRA GxP Data Integrity Guide: Launched March 2018 GXP refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice
  • New national standards launched across the UK to improve public involvement in research. The standards are:
    • A description of what good public involvement in research looks like
    • Designed to encourage self reflection and learning, including where lessons have been learned when public involvement has failed to lead to expected outcomes.
    • A tool to help people and organisations identify what they are doing well, and what needs improving
    • Intended to be used with any method or approach to public involvement in research
    • Adaptable to your own situation and can be used alongside other resources such as case studies, public involvement checklists, and toolkits

Regulatory News

Keep your Forum Directory details up to date as Sponsors to take responsibility for passing on capacity and capability decision.

Organisations are advised to continue to keep accurate contact details on the R&D Forum Directory up to date to ensure they receive all relevant information about studies judged by the HRA to require no formal confirmation of capacity and capability. This is the same contact list previously used by the HRA to contact organisations but that will now be utilised directly by Sponsors to contact sites. Read more about this change in process

Health and Care Research Wales aligns processes and paperwork across England and Wales

Health and Care Research Wales is aligning its processes and paperwork so that there is consistency across England and Wales for researchers. This change is part of an incremental approach in Wales to implementing the local information pack across the UK.

From 16 April 2018 all researchers starting new applications in IRAS with sites in Wales will complete the Statement of Activities/schedule of events (SoA/SoE) rather than Site Specific Information (SSI) applications.

‘In flight studies’ which already have an SSI application in progress will continue to use this route. Until 10 June 2018, applications on either documentation will be accepted in Wales, but after this date all applications should be submitted using SoA/SoE.

All applications received in Wales after 16 April 2018, regardless of the documentation completed, will follow a process that is aligned across England and Wales, and which maintains compatibility across the UK.

Further information is available on the Health and Care Research Wales website.

Radiation Assurance process will launch on 16 April 2018

The new Radiation Assurance process will launch on 16 April 2018. The first phase will be open to all oncology studies involving ionising radiation taking place in the NHS; other study types will follow later in the year as we follow a phased roll-out. Read more

Updated versions of the model agreements for commercially sponsored research in the NHS (mCTA and CRO-mCTA)

Updated versions of the model agreements for commercially sponsored research in the NHS (mCTA and CRO-mCTA) were published on IRAS on 1 March 2018.

The new UK wide templates replace nation specific 2011 versions and, in addressing the most common sponsor modifications made to these templates, mark a significant step in streamlining the contract negotiation element of site set-up across the UK health service. Continue reading

Other News

Funding & programmes

Clinical entrepreneur programme NHS England

NIHR funding awards

Health & Care Research Wales funding awards

Health PhD Studentship Award 2018: Closes 27 March 2018

Other News

NIHR & Charities Consortium for Hospice and Community Research First National Conference: Supportive and Palliative Care Research in the Hospice and Community Setting

Attitudes towards health research 2017: survey of the general public

A national survey supported jointly by the NIHR and HRA reveals strong public support for health research but lower confidence among people from ethnic minorities. The survey showed overall good progress for NHS research but that there is still more to do to build confidence and promote research in a hospital setting: “The survey showed people associate research in the NHS with access to better quality of care. But our survey also found that most people did not believe or were not aware of research taking place in their local hospital” (p3) Access the report and read more
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