CRN: Thames Valley and South Midlands
Annual Plan 2015-16
Val Woods
Chief Operating Officer
National lnstitute fot
Heakh Research
Clini.al Research Networl
NIHR CRN: Thames Valley and South Midlands Annual Plan 2015-16
Host Organisation
Oxford University Hospitals NHS Trust
Partner
Organisations
'1. Berkshire Healthcare NHS Foundation Trust
-
Members of the
Partnership Group
Other affiliated
partners
(eg CCGs/Social
enterprises)
2.
3.
4.
5.
6.
1.
2.
3.
4.
5.
6.
7.
Buckinghamshire Healthcare NHS Trust
Milton Keynes Hospital NHS Foundation Trust
Oxford Health NHS Foundation Trust
Oxford University Hospitals NHS Trust
Royal Berkshire NHS Foundation Trust
NHS
NHS
NHS
NHS
NHS
NHS
NHS
NHS
9. NHS
10. NHS
11. NHS
L
Aylesbury Vale CCc
Bracknelland Ascot CCG
Chiltern CCG
Milton Keynes CCG
Newbury and District CCG
North and West Reading CCG
Oxfordshire CCG
Slough CCG
South Reading CCG
Windsor, Ascot and Maidenhead CCG
Wokingham CCG
Host organisation Accountable Officer for CRN: Thames Valley and South Midlands
Name:
Sir Jonathan l\richael
Contact details
Chief Executive's Office,
Level 3 John Radcliffe Hospital
Oxford
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E m a il: J o n athan.M i c h ael @o uh. n hs. u k
Iel:01865 22'1000
Host nominated Executive Director for CRN: Thames Valley and South Midtands
Name:
Dr Tony Berendt
Contact details
Job title:
lvledical Director
Dr Tony Berendt
I\4edical Director
Chief Executive's Office,
Level 3 John Radcliffe Hospital
Oxford
ox3 9DU
E m a iI : to nv.beren dt@ou h,n h s. u k
Tel:01865 572876
CRN: Thames Valley and South Midlands Clinical Director(s)
Name:
Dr Belinda Lennox
Contact details:
Department of Psychatry
University of Oxford
Warneford Hospital
Headington
Oxford
ox3 7JX
E m a i t : be!!!!3!e!!9I@25Y9!E!4
TeL o1a65 226491
Contact detaib:
University of Oxford Department of Oncology
Oxford Cancer & Haematology Centre
The Churchill Hospital
Headington
Oxford
ox3 7LJ
Dr Andrew Protheroe
Co-Director
Em aiL a nd rcw -proth
e rce@
m
e
d on c, ox. ac. u k
Ielr 01865 572300
CRN: Thames Valley and South Midlands Chief Operating Officer
Name:
Valerie Woods
Contact details:
NIHR CRN: Thames Valley & South Midlands
First Floor, The l\ranor House
The John Radcliffe Hospital
Oxford
ox3 gDZ
Em ail
:
val.woods@ouh,nhs.uk
Tel:
01465223292
Mob:
07774 751572
To be completed by the Host organisation
Please briefly outline the process of engagement and consultation with LCRN Partners
and other stakeholders regarding the submifted LCRN 2015-16 Annual Plan and local
recruitment goals
As
port ofthe plonning process we have-
-developed plon in conjunction with the
LCRN
Executive Group, Clinicol Reseotch Leods ond
O pe roti onal M o n og e me nt G rou p
-discussed plonning with trust R&D Monagers ot meeting in Februory 2015
-distributed both initiol ond finol droltto Partnership Group members and R&D Mdnogers for their
input ond comment
-metwith our Portnerchip Group
the initiol ond finol dtofts
PPIE representatives ond requested
theirleedbock ond input to both
-recruitment goolsfor eoch Speciolty ond the LCRN overullhove been informed by on onolysis of
current studies. study pipelines ond potentiol Ior growth and in o series ol specific plonning meetings
with eoch divisionol Reseorch Delivety Monoger and Clinical Leod. Locol recruitment goolsforeoch
ttustwillbe
discusse
d
furthe r ond linalised once the 2014/15 doto cut hos been token.
The plon wos initidlly tobled for
fomol opprovol ot
the OUHT March Boord meeting, but due
tothe
chonge in the submission timetoble, this will now be included in the Moy Bootd meeting ogendo.
Similorly, we hove rcscheduled our Morch Portnership Group meeting until 23d Aptilwhere we expect
the plon to receive Iormal opprovol.
Nominated Executive Director Assurance
LCRN Host organisation nominated
Executive Director signature confirming
the following are in place for the LCRN:
.
.
.
an assurance framework and risk
management system;
robust and tested local business
continuity arrangements;
an Urgent Public Health Research
Plan.
Dr Tony Berendt
l\.Iedical Direcior
Confitmation of approval of the Annual Plan by the Host organisation Board and by
LCRN Partnership Group (meeting held on 28rh April 2015)
Name:
Dr Tony Berendt
Role:
Medical Director
Signature:
l-
-+k
Email:
to n y, berendt@o uh. nhs. u k
Tel: 01865 572876
Date:
23d June 20'15
Contact for any communication regarding the CRN: Thames Valley and South
Midlends Annual Plan
Email: val.woods@ouh.nhs.uk
Name:
Val Woods
Tel:
Mob:
Role:
Chief Operating Otficer
01865 223292
07774 751572
NIHR CRN: Thames Valley and South Midlands Annual Plan 2015-16
Table of Contents
Table 1: LCRN plans and goals for contributing to NIHR CRN High Level Objectives ........................... 1 Table 2: LCRN plans to contribute to the achievement of NIHR Clinical Research Specialty Objectives ............................................................................................................................................... 5 Group 1: Increasing the breadth of research engagement in the NHS .............................................. 5 Group 2: Portfolio Balance .................................................................................................................. 7 Group 3: Research Infrastructure ..................................................................................................... 10 Table 3: LCRN plans against the Operating Framework...................................................................... 13 Table 4: LCRN Patient and Public Involvement and Engagement Plan .............................................. 19 Table 5: LCRN Continuous Improvement Action Plan ......................................................................... 24 Table 6: LCRN Workforce Plan ............................................................................................................. 25 Appendix 1: LCRN Risk Register ........................................................................................................... 26 Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC ............ 30 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 1: LCRN plans and goals for contributing to NIHR CRN High Level Objectives 2015-16
Objective
1
Increase the number of
participants recruited into
NIHR CRN Portfolio studies
Measure
Number of participants recruited in a reporting year into NIHR
CRN Portfolio studies
CRN
Target
650,000
LCRN Goal
LCRN target
40,000
Aspirational
target
43,000
2
Increase the proportion of
studies in the NIHR CRN
Portfolio delivering to
recruitment target and time
A:
B:
Proportion of commercial contract studies achieving or
surpassing their recruitment target during their planned
recruitment period, at confirmed Network sites
Proportion of non-commercial studies achieving or
surpassing their recruitment target during their planned
recruitment period
80%
80%
80%
80%
Specific key local activities for 2015-16
Timescale
Rationale for targets
The target of 40,000 is slightly below the actual achieved for 2014/15 but still reflects the fact that
the LCRN has higher recruitment per head of population than most other regions. It has been
compiled based on




latest intelligence on pipeline and recruitment available
an updated detailed assessment by Specialty and by trust
takes the reduction in acute trusts from 5 to 4 in the region into account
reflects reliance on high recruiting studies to achieve the overall recruitment target
takes account of all known studies in the pipeline
Local activities for 2015/16
Implement robust pipeline systems to identify potential studies at an earlier point and ensure that
study intelligence is shared with Research Delivery Managers (RDMs), Specialty leads, trust leads
and others across all sites
Documented
process to be rolled
out by June 2015
Develop programme to encourage and support potential new Principle Investigators (PIs), to grow
research capability and sustainability across all sites in the region
Programme to
commence by June
2015
Agree working principle with partner organisations that new studies will be considered for
recruitment in more than 1 site unless this is not feasible
To be discussed at
Partnership Group
meeting in April
2015
Review performance of studies against recruitment targets at LCRN monthly Industry Operations
Meetings which are attended by Industry Operations Manager (IOM), Chief Operating Officer
(COO) and RDMs and invoke escalation process for issues as appropriate.
In place
Improve data quality on national and local systems, including Central Portfolio Management
System (CPMS) and Local Portfolio Management System (LPMS), to ensure that study targets,
timescales and actual recruitment to date are all accurately reported.
Will be on-going in
conjunction with the
implementation
plans for CPMS and
LPMS
Develop specific ‘taskforce’ capabilities within/across each Division to provide enhanced support
where feasible and to respond to short term recruitment issues
By March 2016
Review study performance at the monthly LCRN Operational Management Group meetings and
develop ‘taskforce’ capabilities within/across each Division to provide enhanced support to
respond to short term recruitment issues
Monthly meetings
already in place
Improved taskforce
capabilities
developed by March
2016
Within Oxford University Hospitals NHS Trust (OUHT), agree responsibilities, priorities and
working arrangements between the newly appointed trust-funded RM&G Delivery Managers and
the LCRN RDMs within each of the trust’s divisions with regard to the monitoring of time to target
performance and addressing study blockages
To be agreed by 1st
July 2015
Implement LPMS across the region and build interface with CPMS to ensure that one accurate
source of study and recruitment data is being used for performance management and monitoring
across the region
LPMS to be
implemented by
April 2015 with
additional
functionality,
including CPMS
interface, developed
during 2015
1
Objective
3
Increase the number of
commercial contract studies
delivered through the NIHR
CRN
Measure
A:
B:
4
5

Reduce the time taken for
eligible studies to achieve
NHS Permission through
CSP
Reduce the time taken to
recruit first participant into
NIHR CRN Portfolio studies
Number of new commercial contract studies entering
the NIHR CRN Portfolio
Number of new commercial contract studies entering
the NIHR CRN Portfolio as a percentage of the total
commercial MHRA CTA approvals for Phase II–IV
studies
Proportion of eligible studies obtaining all NHS Permissions
within 40 calendar days (from receipt of a valid complete
application by NIHR CRN)
A:
B:
Proportion of commercial contract studies achieving
first participant recruited within 30 calendar days of
NHS Permission being issued or First Network Site
Initiation Visit, at confirmed Network sites
Proportion of non-commercial studies achieving first
participant recruited within 30 calendar days of NHS
Permission being issued
CRN
Target
600
75%
80%
80%
80%
LCRN Goal
n/a
n/a
n/a
80%
80%
Specific key local activities for 2015-16
Timescale
LCRN industry team to lead and complete on current contract and costing harmonisation initiatives
in collaboration with trust finance and contract teams to ensure that the LCRN region can offer
streamlined systems and processes to commercial partners
By March 2016
Deliver programme of engagement events for commercial partners, including a high profile
Industry event, to showcase the CRN’s national and local capabilities with regard to delivery of
Portfolio commercial studies.
Event to be organised in collaboration with national CRN industry team and regional partners
including Biomedical Research Centre (BRC), Biomedical Research Unit (BRU), Diagnostic
Evidence Co-operative (DEC), Collaboration for Leadership in Applied Health Research and Care
(CLAHRC), Academic Health Science Network (AHSN)
October 2015
Update the LCRN Industry Strategy in line with 2015/16 Performance Operating Framework
objectives for Partnership Group approval.
Strategy to ensure alignment between individual trust and LCRN strategies, systems, processes
and timelines for engaging with commercial partners and will incorporate specific Primary Care
strategy
April 2015
The LCRN is already above the target level for this measure.
Some current studies in the region may not be Portfolio adopted so, in conjunction with trusts, we
will continue to monitor and process-map the approval processes in trusts to ensure optimum
uptake of the Portfolio ( as part of our continuous improvement work stream)
Quarterly
monitoring
Mapping project to
be completed by
end September
2015
Engage with companies and investigators who have studies which have not been put forward for
inclusion onto the Portfolio to identify problems and blockages
On-going
Prepare specific promotional materials featuring the benefits of the CRN and the LCRN and
detailing the processes required for Portfolio inclusion
September 2015
Currently meeting this target.
Will focus on continuation of existing process throughout next financial year
On-going
Early planning to ensure that a smooth handover is experienced by researchers with the advent of
the Health Research Authority’s (HRA) approval process
On-going
Review performance of studies against recruitment targets at LCRN Monthly Industry Operations
Meetings which are attended by IOM, COO, and RDMs
Monthly meetings
already in place
In conjunction with trusts, implement a ‘warning system’ from CPMS or LPMS data, to flag up
when studies are nearing the 30 day limit if there has been no recruitment
Dependent on
CPMS and LPMS
timelines
Use Open Data Platform (ODP) to develop new reports on 30 day achievement (once CPMS in
place) for inclusion in the LCRN monthly information packs
Dependent on
CPMS timelines
Implement LPMS in member trusts and build interface with CPMS to ensure that one accurate
source of study and recruitment data is being used for performance management and monitoring
across the region
Dependent on
LPMS and CPMS
timelines

See Operating Framework Clause 5.28 2
Objective
6
Increase NHS participation in
NIHR CRN Portfolio Studies
Measure
CRN
Target
LCRN Goal
Specific key local activities for 2015-16
Timescale
In conjunction with trusts, implement a ‘ warning system’ from CPMS or LPMS data, to flag up
when studies are nearing the 30 day limit if there has been no recruitment
Dependent on
CPMS and LPMS
timelines
Use ODP to develop new reports on 30 day achievement (once CPMS in place) for inclusion in the
LCRN monthly information packs
Dependent on
CPMS timelines
A:
Proportion of NHS Trusts recruiting each year into
NIHR CRN Portfolio studies
99%
99%
Maintain 100% achievement
On-going
B:
Proportion of NHS Trusts recruiting each year into
NIHR CRN Portfolio commercial contract studies
70%
70%
All our trusts currently recruit to commercial studies except Milton Keynes Foundation Trust
(MKFT) which has now been selected as a site for several studies and is actively submitting further
Expressions Of Interest (EOIs). We will continue to offer them support to develop their capabilities
to undertake commercial studies
100% of trusts to be
recruiting to
commercial studies
by March 2016
Commercial activity by trust will be reported to the Partnership Group at each meeting
Throughout 2015/16
For 2014/15 we have 31.9% of General Medical Practices recruiting into CRN Portfolio studies but
this ranges between CCGs from 3.6% to 57.1%;

Develop GP Champions role and collaborate with Department of Primary Care at Oxford
University (DoPC) to increase GP engagement

Introduction of a performance management system to support identification of areas of
need
On-going
RSI currently being
launched
C:
Proportion of General Medical Practices recruiting each
year into NIHR CRN Portfolio studies
25%
25%

Implementation of the Research Site Initiative (RSI) scheme
7
Increase the number of
participants recruited into
Dementias and
Neurodegeneration
(DeNDRoN) studies on the
NIHR CRN Portfolio
Number of participants recruited into Dementias and
Neurodegeneration (DeNDRoN) studies on the NIHR CRN
Portfolio
13,500
1,600
Restructure Primary Care Delivery Team to enable provision of a region wide service and direct
support to GP Practices
Completed by end
June 2015
Introduction of enhanced monthly performance management system to support geographic
identification of areas where there is little activity
By April 2015
Rationale for target
The target of 1,600 is slightly higher than the actual achieved for 2014/15. It has been compiled
based on the latest intelligence on pipeline and recruitment available and an updated detailed
assessment by trust.
On-going
The aspirational target for recruitment to DeNDRoN studies is 1,700
Local activities for 2015/16
Review all commercial study opportunities with robust feasibility to ensure that studies will achieve
time and target
Continue to proactively support the OPDC – Parkinson’s cohort study – which runs at all acute
sites in the LCRN. This enables the wider support of Oxford University-derived Parkinson’s
research programmes, alongside on-going management of 4 Parkinson’s research interested
databases
Work more collaboratively with the clinical research facility (CRF) at the Warneford Hospital, to
drive a model where the DeNDRoN teams focus on recruitment and rating activities, with the CRF
team taking on study coordination and study delivery activities for trials. This enables the
DeNDRoN team to focus more on recruitment activities and delivering studies in the community,
and overall building delivery capacity
May 2015 and
on-going
3
Objective
Measure
CRN
Target
LCRN Goal
Specific key local activities for 2015-16
Build capacity in Berkshire Healthcare NHS Foundation Trust (BHFT) in order to take on more
DeNDRoN studies, and use a whole network approach to support the BHFT team, using staff with
letters of access from Oxford Health NHS Foundation Trust (OxHealth) and Royal Berkshire NHS
Foundation Trust (RBFT)
Timescale
By July 15 and
on-going
4
CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 2: LCRN plans to contribute to achievement of NIHR CRN Clinical Research Specialty Objectives 2015-16
GROUP 1: INCREASING THE BREADTH OF RESEARCH ENGAGEMENT IN THE NHS
Increasing the opportunities for patients to participate in NIHR CRN Portfolio studies
ID
Specialty
Objective
Measure
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
1.1
Cancer
Increase the opportunities for cancer patients to take part in
research studies, regardless of where they live, as reflected
in National Cancer Patient Experience Survey responses
Number of LCRNs which have an action plan to increase
access in each subSpecialty (eg by opening studies,
increasing awareness and forming referral pathways for
access to research)
15
Sub-Specialty leads are currently being appointed to spearhead this work and
an action plan will be developed
We will also develop new reporting packs to track activity and anticipated
pipelines in each Sub-Specialty and for each of our 4 acute hospitals
1.2
Children
All relevant sites that provide services to children are
involved in research
Proportion of NHS Trusts recruiting into Children’s studies on
the NIHR CRN portfolio
95%
3 of our 4 acute trusts are recruiting to at least one NIHR CRN Portfolio study
Planned activities include
To appoint Children’s Research Nurse in the trust with no activity to start
in Q1 of 2015/16

To increase Portfolio of studies in active trusts

To develop the role of the LCRN Senior Research Nurse to continue
support of Children’s Research Nurses and engage new PIs

To continue to develop Portfolio of commercial studies in OUHT and RBFT
and identify opportunities for MKFT and BucksHT
1.3
Critical Care
Increase intensive care units’ participation in NIHR CRN
Portfolio studies
Proportion of intensive care units recruiting into studies on
the NIHR CRN Portfolio
80%
Engage research interested clinicians from MKFT and BucksHT to attend LCRN
Critical Care Speciality research meetings that run alongside the thrice yearly
Oxford Regional Intensive Care Society meetings.
Identify observational studies on the Portfolio that might act as a means for
MKFT and BucksHT to get Critical Care research up and running in their units.
Run an LCRN conference / study day to inform about research studies
completed / in progress and encourage networking of staff with an interest in
research related to Critical Care from across the region.
RDM to scan Portfolio for potential studies and communicate with research lead
clinicians in intensive care units.
The current research lead clinicians in intensive care units also hold consultant
anaesthetic positions. Therefore encourage these teams to engage in
Anaesthesia Portfolio studies.
1.4
Dermatology
Increase NHS participation in Dermatology studies on the
NIHR CRN Portfolio
Number of sites recruiting into Dermatology studies
150
Increase recruitment to non-commercial Portfolio studies across the region
through widening clinician and participant awareness of studies, and simplified
pathways of recruitment.
Increase recruitment to commercial studies through direct links between PI and
industry and completion of SIFs through SPoC
Develop the role of band 7 research nurse towards higher management training
for activities including grant applications and facility development
Collaborate with other specialties on joint projects; opportunities already
identified with Musculoskeletal (MSK)
1.5
Ear, Nose and
Throat (ENT)
Increase NHS participation in Ear, Nose and Throat studies
on the NIHR CRN Portfolio
Proportion of acute NHS Trusts recruiting into ENT studies on
the NIHR CRN Portfolio
40%
Recruit an LCRN ENT Specialty lead to fill the current vacancy.
Support the Lead Research Nurse based in OUHT to work with nurses from
BucksHT and MKFT on recruitment into the Genetics of Otitis Media study.
Establish an LCRN ENT research identity with view to encouraging participation
in Portfolio studies across trusts, by holding an initial meeting of ENT research
active / interested staff from the various trusts and agreeing a format for regular
future meetings.
1.6
Gastroenterology
Increase NHS participation in Gastroenterology studies on
the NIHR CRN Portfolio
Proportion of acute NHS Trusts recruiting into
Gastroenterology studies on the NIHR CRN Portfolio
90%
Use the existing Oxford Region Gut Club forum (held three times a year) to
provide an update on LCRN research activity and to encourage / support
research interested staff from trusts outside Oxford to participate in Portfolio
studies.
5
ID
Specialty
Objective
Measure
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
1.7
Haematology
Increase NHS participation in Haematology studies on the
NIHR CRN Portfolio
Proportion of eligible NHS Trusts undertaking Haematology
studies in each LCRN
50%
2 out of 4 Trusts recruiting to at least one NIHR CRN Portfolio study
To identify an appropriate study and engage clinicians in 1 additional trust
Provide resource to enable the opening of 2 Portfolio studies at OUHT, with
support for DGHs
1.8
Injuries and
Emergencies
Increase NHS major trauma centres’ participation in NIHR
CRN Portfolio studies
Proportion of NHS major trauma centres recruiting into NIHR
CRN Portfolio studies
100%
The major trauma centre in the LCRN region is OUHT which is actively
participating in recruitment.
1.9
Injuries and
Emergencies
Increase NHS emergency departments’ participation in
NIHR CRN Portfolio studies
Proportion of NHS emergency departments recruiting into
NIHR CRN Portfolio studies
30%
Continue to support emergency departments within RBFT and MKFT both of
which are currently recruiting to Portfolio studies.
Engage with research-interested staff in the Emergency Department at Stoke
Mandeville Hospital (BucksHT) to encourage them to become involved in
recruiting to Portfolio studies.
Offer and provide support in design of investigator initiated studies, to maximise
the opportunities for inclusion onto the Portfolio
Continue to facilitate the established LCRN Injuries & Emergencies Specialty
Group meetings (held quarterly) and annual conference. Encourage research
interested staff from all trusts to attend and participate in studies.
1.10
Musculoskeletal
Increase NHS participation in Musculoskeletal studies on
the NIHR CRN Portfolio
Number of sites recruiting into Musculoskeletal studies on
the NIHR CRN Portfolio
300
Studies are already open and recruiting at all trusts within the LCRN.
Activity will be maintained and further increased through active engagement with
clinicians and research staff at regional meetings and events.
A process will be implemented to assess feasibility and deliverability of
commercial studies so as to increase activity
There will be a rebalancing of skill mix to reflect demand from new studies. This
will enable the team to maintain support for Vasculitis and Rheumatology
studies, but also to increase recruitment from osteoarthritis, rehab and crossdivisional studies.
1.11
Ophthalmology
Increase NHS participation in Ophthalmology studies on
the NIHR CRN Portfolio
Proportion of acute NHS Trusts recruiting into
Ophthalmology studies on the NIHR CRN Portfolio
60%
1.12
Renal Disorders
Increase the proportion of NHS Trusts recruiting into Renal
Disorders studies on the NIHR CRN Portfolio which actively
engage renal and urological patients in research
Proportion of NHS Trusts recruiting into Renal Disorders
studies on the NIHR CRN Portfolio which implement Patient
Carer & Public Involvement and Engagement (PCPIE)
strategies for Renal Disorders research
25%
Provide support for the Sleep Study – a relatively large new study co-ordinated
from Oxford and involving RBFT and BucksHT
Build on research interest from Mandip Bindra and Richard Smith at Stoke
Mandeville Hospital (BucksHT) to support involvement in Portfolio studies.
Arrival at Stoke Mandeville Hospital of Markus Groppe - a new Medical Retina
Consultant who previously worked with OUHT ( Prof McLaren) as an academic
fellow - who is likely to be proactive in terms of research.
RDM to scan Portfolio and liaise with R&D staff in trusts to find studies
appropriate to the services / expertise in individual trusts. For example at MKFT
there are consultants who are keen to participate in research studies but
recognise that the studies would need to be aimed at patients with relatively
basic problems. Patients with more complex problems are referred elsewhere.
Research interested / active staff in other trusts to be encouraged to attend the
regular research meetings held at the Eye Research Group Oxford (ERGO)
with a view to creating a network-wide identify. Use this group to inform,
encourage and support staff from other trusts to participate in recruiting to
studies.
Support ERGO to make patients aware of Ophthalmology research and
develop database of patients with interest in research so information sheets
about studies can be distributed directly.
The region has 4 trusts with renal units associated with them, but these are all
legally entities of either OUHT or RBFT. As such patients seen in MKFT or
BucksHT are seen as OUHT or RBFT patients. All centres have information on
research studies available to patients and some have patient groups associated
with clinical service that the LCRN intends to approach with regards to
supporting research activities.
6
ID
Specialty
Objective
Measure
Target
1.13
Stroke
Increase the proportion of NHS Trusts, providing acute
Stroke care, recruiting to Stroke studies on the NIHR CRN
Portfolio
Proportion of NHS Trusts, providing acute Stroke care,
recruiting participants into Stroke studies on the NIHR CRN
Portfolio
80%
1.14
Surgery
Increase NHS participation in Surgery studies on the NIHR
CRN Portfolio
Proportion of acute NHS Trusts recruiting patients into
Surgery studies on the NIHR CRN Portfolio
85%
LCRN activities and initiatives to contribute to achievement of objective(s)
All acute trusts are participating in Portfolio stroke studies and the LCRN will
continue to engage with them in order to promote participation in Portfolio
research studies. OUH is beginning to build a stroke research registry to
facilitate future stroke research.
Recruit three Research Nurses to vacancies created by departure of previous
postholders. Create and support a new team to provide a flexible resource to
work across trusts in the LCRN region.
Ensure all staff involved in recruiting attend specialist training in recruitment of
participants to surgery studies.
Create a forum for research active / interested surgeons to meet to consider
involvement in Portfolio studies. Expand this group to include surgeons from all
trusts.
RDM to scan Portfolio for appropriate potential studies and communicate with
Speciality lead and relevant surgeons across the network.
GROUP 2: PORTFOLIO BALANCE
Delivering a balanced portfolio (across and within Specialties) that meets the needs of the local population and takes into account national Specialty priorities
ID
Specialty
Objective
Measure
2.1
Ageing
Increase access for patients to Ageing studies on the
NIHR CRN Portfolio
Proportion of Ageing-led studies which are multicentre
studies
2.2
Cancer
Increase the number of cancer patients participating in
studies, to support the national target of 20% cancer
incidence
Number of LCRNs recruiting at or above the national target
of 20%, or with an increase compared with 2014-15
2.3
2.4
Cancer
Cancer
Increase the number of cancer patients participating in
interventional trials, to support the national target of 7.5%
cancer incidence
Deliver a Portfolio of studies including challenging trials in
support of national priorities
Number of LCRNs recruiting at or above the national target
of 7.5%, or with an increase compared with 2014-15
Number of LCRNs recruiting into studies in:




Cancer Surgery
Radiotherapy
Rare cancers (cancers with incidence
<6/100,000/year)
Children's Cancer & Leukaemia and Teenagers &
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
50%
The LCRN has plans to recruit a Specialty Lead and develop its Age and Ageing
Portfolio but this may take some time since there are no active studies in the
region
15
From latest published data, the LCRN is currently achieving approximately 11%
against this target and it is unlikely therefore that this can be increased to 20%
within the next financial year. Activities we will undertake to improve our
achievement include-
15
15

new RDM appointed with effect from 1st February 2015

produce metrics to highlight the performance by acute trust to focus on
areas of poor achievement

scan the study pipeline to identify and support new interventional studies

develop an additional flexible workforce within the LCRN with the
capabilities and capacity to recruit to Cancer studies (including surgery
studies)
From latest published data, the LCRN is currently achieving approximately 5%
for this measure. Activities we will undertake to improve our achievement
include
new RDM appointed with effect from 1st February 2015

produce metrics to highlight the performance by acute trust to focus on
areas of poor achievement

scan the study pipeline to identify and support new studies

develop an additional flexible workforce within the LCRN with the
capabilities and capacity to recruit to Cancer studies
OUHT is the only site running children’s and young adults’ cancer and
Leukaemia trials. We will seek to expand these studies if feasible to other sites
Radiotherapy studies are already open in OUHT, RBFT and BucksHT and we
will endeavour to continue to run such studies in all our trusts
Trials in rare cancers are currently running in OUHT (Early and Late Phase
Teams), RBFT and MKFT,
7
ID
Specialty
Objective
Measure
Target
Young Adults
LCRN activities and initiatives to contribute to achievement of objective(s)
Recruiting to cancer surgery studies is a key priority for the LCRN. 3 research
nurses are currently being recruited to work for the network as a flexible
resource. They will be tasked with developing the cancer surgery Portfolio,
initially in Oxford
2.5
Cardiovascular
Disease
Increase access for patients to Cardiovascular Disease
studies on the NIHR CRN Portfolio
Number of LCRNs recruiting into multi-centre studies in at
least five of the six Cardiovascular Disease subSpecialties
15
In the financial year 2014/15, the LCRN recruited into multicentre studies in all
six sub-Specialties, we expect this to continue in 2015/16
The network is engaging with all trusts in the region to promote cardiovascular
studies. All secondary care providers in the region have active research studies.
The LCRN circulates studies trying to identify new sites on a regular basis to
encourage participation. The LCRN have identified and engaged with specific
trusts and clinical teams in the current financial year in order to grow
participation in the region.
The Cardiovascular Specialty promotes research in the region by organising an
annual research day to highlight cardiovascular research in the region, this is
rotated around sites in order to encourage participation across the region
2.6
Diabetes
Increase support for areas of Diabetes research where
traditionally it has been difficult to recruit
Number of LCRNs recruiting into diabetic foot studies on the
NIHR CRN Portfolio
15
The LCRN regularly distributes diabetic foot studies to sites across the region,
several sites are interested in these studies and there is active engagement with
foot care teams including for commercial studies. RBFT were selected for the
Leucopatch study in 2014/15, and were already supporting the HEELS study.
There is a very active strategic clinical network initiative to improve diabetic foot
care in the region, this objective synergises with this initiative.
2.7
Diabetes
Increase access for people with Type 1 Diabetes to
participate in Diabetes studies on the NIHR CRN Portfolio
early after their diagnosis
Number of LCRNs approaching people with Type 1 Diabetes
to participate in interventional Diabetes studies on the NIHR
CRN Portfolio within six months of their diagnosis
15
All of the secondary care sites in the region are taking part in the ADDRESS2
study. As interventional studies become available on the Portfolio suitable
patients are approached to participate in these studies. The network is actively
supporting DRN827 which is led by Prof Steve Gough. The paediatric research
group is supporting UKCRN16990 that recruits type 1 patients within 6 months of
diagnosis and will be active in 2015/16, as well as several other T1 diabetes
studies
2.8
Gastroenterology
Increase the proportion of patients recruited into
Gastroenterology studies on the NIHR CRN Portfolio
Number of participants (per 100,000 population), recruited
into Gastroenterology studies on the NIHR CRN Portfolio
15
Widen research activity to include more emerging Gastroenterology subSpecialties associated with identified and appropriately experienced potential
PIs including: Luminal (Travis, Keshav, Brain); Endoscopy (East); GI Bleeding
(Jairath, Bailey); Oesophageal (Bird, Lieberman); Immunobiology (Simmons);
Imaging (Slater).
Support the development of the FINS study aimed at recruiting a relatively large
number of people with faecal incontinence.
Engage with Industry and support increase in number of commercial studies to
evaluate new drugs aimed at Inflamed Bowel Disease.
Support the development of more investigator-initiated studies.
Support PPIE initiatives to create a public / patient website and facilitate patient
research meetings to consider current research priorities and studies.
2.9
Genetics
Increase access for patients with rare diseases to
participate in Genetics studies on the NIHR CRN Portfolio
Number of LCRNs recruiting into multi-centre Genetics
studies through the NIHR UK Rare Genetic Disease
Research Consortium
14
The LCRN is participating in studies through the NIHR UK Rare Genetic Disease
Research Consortium
Following staffing difficulties in 2014/15 there is a need to maintain study
participation and recruitment and 2 new research nurses to be in post Q1
2015/16
We will engage clinicians in trusts across the region to identify barriers and
promote solutions to improve patient access to study participation outside Oxford
2.10
Haematology
Increase access for patients to Haematology studies
undertaken by each LCRN
Number of LCRNs recruiting into studies in at least three of
the four following Haematology subSpecialties :
Haemoglobinopathy, Thrombosis, Bleeding disorders,
Transfusion
15
The LCRN has active studies in Thrombosis, Bleeding disorders, Transfusion but
there is potential for increased activity across the region.
We aim to identify an appropriate study and engage clinicians in 1 additional
trust
8
ID
Specialty
Objective
Measure
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
We will provide resource to enable the opening of 2 Portfolio studies at OUHT,
with support for other sites
2.11
Hepatology
Increase access for patients to Hepatology studies on the
NIHR CRN Portfolio
Number of LCRNs recruiting into a multi-centre study in all of
the major Hepatology disease areas (including Viral
Hepatitis, NAFLD, Autoimmune Liver Disease, Metabolic
Liver Disease)
15
Build on existing LCRN Hepatitis research Portfolio which includes academic
and commercial studies in set up targeting Auto-immune disease, NAFLD and
Viral Hepatitis.
Provide support to the new consultant with the Hepatology team at OUHT, Dr
Jeremy Cobbold, who has a specialist interest in non-alcoholic fatty liver disease
(NAFLD). NAFLD is a current western epidemic and is opening up major new
research opportunities. He has initiated a specialist NAFLD clinic which will help
to facilitate recruitment to studies.
Support the development of clinical cohorts and databases in all the major liver
disease areas to ensure access to the right patients to optimise study
recruitment.
Continue to support the regular (6 weekly) LCRN meetings involving the Oxford
Hepatology team and researchers/clinicians from trusts across the region to
ensure access for patients to research is communicated regionally. These
meetings are currently attended by clinicians from RBFT and BucksHT. There is
a need to encourage representation from MKFT.
2.12
Infectious Diseases
and Microbiology
Increase access for patients to Infectious Diseases and
Microbiology studies on the NIHR CRN Portfolio
Number of LCRNs recruiting into antimicrobial resistance
research studies on the NIHR CRN Portfolio
15
Build upon existing active LCRN involvement in multi-centre anti-microbial
resistance research studies including ARREST, CIVAS and OVIVA.
Build links and facilitate better awareness, communication and co-ordination
between the various groups in the LCRN area actively involved in research in the
Infectious Diseases & Microbiology Specialty.
Encourage local Chief Investigators (CIs) to have studies adopted on Portfolio.
Offer and provide support in design of investigator initiated studies to maximise
the chance of acceptance onto the Portfolio.
2.13
Metabolic and
Endocrine
Disorders
Increase access for patients with rare diseases to
participate in Metabolic and Endocrine Disorders studies
on the NIHR CRN Portfolio
Number of LCRNs recruiting into established studies of rare
diseases in Metabolic and Endocrine Disorders on the NIHR
CRN Portfolio
15
The LCRN will promote participation in M & E studies to investigators across the
region. The clinical lead for M & E has arranged a research awareness seminar
to promote greater participation across the region. M&E activity is expected to be
one of the growth areas within Div. 2 over the next 12 months.
2.14
Oral and Dental
Increase access for patients and practitioners to Oral and
Dental studies on the NIHR CRN Portfolio
A:
Proportion of Oral and Dental studies on the NIHR
CRN Portfolio recruiting from a primary care setting
20%
The LCRN does not currently have an active Portfolio of studies in this Specialty
and is hampered by the absence of a dental school in the region.
We aim to appoint a Specialty Lead for Oral and Dental by the end of March
2015.
B
Proportion of participants recruited from a primary care
setting into Oral and Dental studies on the NIHR CRN
Portfolio
30%
See above
2.15
Primary care
Increase access for patients to NIHR CRN Portfolio studies
in a primary care setting
Proportion of NIHR CRN Portfolio studies delivered in
primary care settings
15%
Develop GP Champions role and collaborate with DoPC to increase GP
engagement
Restructure Primary Care Delivery Team to enable provision of a region wide
service and direct support to GP Practices
Introduction of an improved performance management system to support
identification of areas of need
Implementation of the RSI scheme
2.16
Renal Disorders
Increase NHS participation in Renal Disorders studies on
the NIHR CRN Portfolio
A.
30%
The region has 4 acute NHS trusts with renal units associated with them, but
these are all legally entities of either OUHT or RBFT. Thus, all centres either
recruit patients into interventional studies or act as Patient Identification Centres
(PIC) sites for OUHT or RBFT-led studies.
The LCRN will continue to promote the available Randomised Controlled Trials
(RCT) studies across the region.
Proportion of acute NHS Trusts recruiting into multicentre Renal Disorders randomised controlled trials on
the NIHR CRN Portfolio
9
ID
Specialty
Objective
B.
Measure
Target
Proportion of Renal Units recruiting into multi-centre
Renal Disorders randomised controlled trials on the
NIHR CRN Portfolio
80%
LCRN activities and initiatives to contribute to achievement of objective(s)
As above
C.
2.17
Respiratory
Disorders
Increase access for patients to Respiratory Disorders
studies on the NIHR CRN Portfolio
Number of LCRNs recruiting participants into NIHR CRN
Portfolio studies in the Respiratory Disorders main disease
areas of Asthma, COPD or Bronchiectasis
15
Develop support for researchers with specific interest Asthma and COPD. This is
a relatively new topic of research for Oxford and the LCRN. The arrival of Dr
Bafadhel and Prof Porvord with experience of, and interest in, Asthma and
COPD research provides an important opportunity to expand research and
recruitment in this area.
Support involvement in existing multicentre Portfolio studies aimed at Asthma
and COPD e.g. Brightling-3.
Developing better links and understanding between primary and secondary care
in relation to Asthma and COPD research in order to facilitate better access to
patients.
Encourage communication and co-ordination between research staff in the
Critical Care, Infectious Diseases and Respiratory Disorders Specialties in
relation to Pneumonia studies.
Generate increased interest in Respiratory Disorder research outside of Oxford
in RBFT, MKFT and BucksHT by means of a summit / event.
2.18
Stroke
Increase the proportion of patients recruited into Stroke
randomised controlled trials on the NIHR CRN Portfolio
Number of patients (per 100,000 population) recruited into
Stroke randomised controlled trials on the NIHR CRN
Portfolio
8
The LCRN regularly circulates information on studies looking for additional sites
to all centres in the region. RCT’s are actively promoted and the development of
a balanced portfolio at each site, with a mix of RCT and observational studies is
encouraged. As previously mentioned a research registry for stroke patients is
being developed at OUH at present to assist in this objective.
2.19
Stroke
Increase activity in NIHR CRN Hyperacute Stroke
Research Centres (HSRCs)
A:
Number of patients recruited to Hyperacute Stroke
studies on the NIHR CRN Portfolio in each NIHR CRN
HSRC
50
No HSRC centres in the region although some HSRC studies are active in the
region
B:
Number of patients recruited to complex Hyperacute
Stroke studies on the NIHR CRN Portfolio in each
NIHR CRN HSRC
15
No HSRC centres in the region although some HSRC studies are active in the
region
GROUP 3: RESEARCH INFRASTRUCTURE
Developing research infrastructure (including staff capacity) in the NHS to support clinical research
ID
Specialty
Objective
Measure
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
3.1
Cancer
Establish local clinical leadership and a defined portfolio
across the cancer subSpecialty areas
Number of LCRNs with, for each of the 13 Cancer
subSpecialties, a named lead and a defined portfolio of
available studies
15
We have worked with the Cancer Strategic Clinical Network within the Local
Area Team (LAT) to develop a robust process for leadership of the 13 subSpecialties which is now clearly documented.
Jointly, we have worked to identify leads for sub-Specialties. As at 10th February
2015 we have named leads for 10 of the 13 sub-Specialties. For the remainder,
the lead activity will nominally will fall under the remit of the PBOG leads whilst
we seek more nominations. The role has a robust role description
A new RDM for Division 1 started on 1st February who will support this process
3.2
Anaesthesia,
Perioperative
Medicine and Pain
Management
Establish links with the Royal College of Anaesthetists’
Specialist Registrar networks to support recruitment into
NIHR CRN Portfolio studies
Number of LCRNs where Specialist Registrar networks are
recruiting into NIHR CRN Portfolio studies
4
Engage with Oxford Deanery Anaesthetic Trainees (OxDAT) which organises
training for Anaesthetist Specialist Registrars in the area.
Encourage and facilitate OxDAT to build upon current activities to support
recruitment into Portfolio studies.
RDM to scan Portfolio for potential new studies and communicate with Clinical
Lead and OxDAT.
10
ID
Specialty
3.3
Dementias and
Neurodegeneration
(DeNDRoN)
Objective
Optimise the use of “Join Dementia Research” to support
recruitment into DeNDRoN studies on the NIHR CRN
Portfolio
Measure
The proportion of people identified for DeNDRoN studies on
the NIHR CRN Portfolio via “Join Dementia Research”
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
3%
With the support of the Join Dementia Research (JDR) project manager, execute
a comprehensive JDR promotional plan, which includes raising awareness
among the following key sectors
NHS trust communications teams and events;

NHS clinical teams who care for people with dementia and wards/memory
clinics; third sector organisations (eg Age UK, Young Dementia Research,
Oxford Federation of Women’s Institutes, Thames Valley U3A, ARUK,
Alzheimer’s Society networks); primary care – GPs and community
hospitals; dementia advisors; dementia research awareness events).
Locally support the national media launch with local activities
Use 2 existing JDR champions to maximise JDR promotion – identify a
third champion in Berkshire.
Record and report on screening logs to monitor local study participation via
JDR
Offer JDR to people who have signed up to existing research interested
dementia/control databases in Berkshire and Oxon/Bucks



3.4
Dementias and
Neurodegeneration
(DeNDRoN)
Increase the global and psychometric rating skills and
capacity of LCRN staff supporting DeNDRoN studies on
the NIHR CRN Portfolio
Proportion of LCRN staff who support DeNDRoN studies
who have successfully completed Rater Programme
Induction and joined the national Rater database
40%
By March 2015, 14/28 staff will have attended rater induction events
Monitor registration on the register following attendance at rater induction events
Support local delivery of rater induction events and rating forums for existing
raters using local practice leads (4 in region). Discuss with COO to ensure
budget in place if external facilitators are required
Support local practice leads to participate in the national practice lead
community, and allow sufficient time in work plan to do so
Ensure that local job descriptions include the requirement to conduct
psychometric and/or global rating scales
Include rating development skills in staff objectives
3.5
Infectious Diseases
and Microbiology
Maintain research preparedness to respond to an urgent
public health outbreak
Number of LCRNs maintaining a named Public Health
Champion
15
The LCRN has developed and approved an Expedited Study Process for Urgent
Public Health Studies.
An urgent Public Health Champion has been appointed – Dr Dushyant Mital.
3.6
Mental Health
Maintain and enhance the skills and capacity of staff
supporting Mental Health studies on the NIHR CRN
Portfolio in frequently used Mental Health study eligibility
assessments (e.g. PANSS, MADRS, MCCB)
Number of staff trained in frequently used Mental Health
study eligibility assessments
139
Develop 2 practice leads to support the on-going development of rating skills
(Oxford/Bucks and Berkshire) in staff across the region.
Ensure collaborative working and idea sharing between Mental Health and
DeNDRoN rating practice leads.
We have 17 PANSS certified raters in the region; we must ensure that these
certified raters have adequate opportunities to retain rating skills/competency by
live experience in studies and use of PPI volunteers as appropriate
Rationally appraise NIHR resource use in Division 4 and map against our key
objectives and potential means of achieving them
Pursue the integration of clinical care and research recruitment
3.7
Neurological
Disorders
Increase clinical leadership capacity and engagement in
each of the main disease areas in the Neurological
Disorders (MS; Epilepsy and Infections) Specialty
Number of LCRNs with named local clinical leads in MS;
Epilepsy and Infections
15
Neurological disorders Specialty leads to identify local clinical leads. At the
current time, we have suitable candidates who would be willing to support this
activity.
Enable and support these leads to develop local engagement and capacity,
particularly across DGHs
3.8
Reproductive
Health and
Childbirth
Increase engagement and awareness of the Reproductive
Health and Childbirth Specialty
Number of LCRNs with a named midwifery lead to increase
engagement and awareness
15
A Midwife Champion has been identified in the LCRN and has participated in the
national discussions held to date
Engage with Clinical leads within the 4 trusts across the region to increase
participation in both commercial and non-commercial obstetrics and gynaecology
research
Provide opportunities for research midwives and nurses to collaborate more
closely and cross work between obstetrics and gynaecology studies
11
ID
Specialty
Objective
Measure
Target
LCRN activities and initiatives to contribute to achievement of objective(s)
Provide training, education and networking opportunities to research nurses and
midwives across the region through a bi-annual Division 3 meeting
12
CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 3: LCRN plans against the Operating Framework 2015-16
POF Area
LCRN Governance
Research Delivery
Operating Framework requirement
Operating
Framework
Reference
Information required
Planned LCRN actions/activities for 2015-16 or other requested
information
Milestones &
outcomes once
complete
Timescale
The Host organisation shall develop and
maintain an assurance framework
including a risk management system
3.12
Assurance that a framework and system are
in place to be provided by the Host
organisation nominated Executive Director’s
signature on Annual Plan coversheet and
submission of a copy of the latest version of
the LCRN’s risk register as Appendix 1 to the
Annual Plan
N/A
N/A
N/A
The Host organisation will ensure that
robust and tested local business
continuity arrangements are in place for
the LCRN. This is to enable the Host
organisation to respond to a disruptive
incident, including a public health
outbreak, e.g. pandemic or other related
event, maintain the delivery of critical
activities / services and to return to
‘business as usual’. Business continuity
arrangements should be in line with
guidance set out by the national CRN
Coordinating Centre.
3.14
Assurance that robust and tested local
business continuity arrangements are in place
for the LCRN to be provided by the Host
organisation nominated Executive Director’s
signature on Annual Plan coversheet
N/A
N/A
N/A
The Host organisation must ensure that
appropriate arrangements are in place to
support the rapid delivery of urgent public
health research, which may be in a
pandemic or related situation. It shall
ensure that the LCRN has an Urgent
Public Health Research Plan which can
be immediately activated in the event that
the Department of Health requests
expedited urgent public health research.
The Host must also appoint an active
clinical investigator as the LCRN’s Public
Health Champion to act as the key link
between the LCRN and the national CRN
Coordinating Centre and support the
Urgent Public Health Research Plan in
the event of it being activated.
3.15
Assurance that the LCRN has an Urgent
Public Health Research Plan in place to be
provided by the Host organisation nominated
Executive Director’s signature on Annual Plan
coversheet
Existing plan to be activated upon request
As per plan
Not known
Confirm name and contact details of LCRN’s
Public Health Champion against Specialty
objective 3.5
Provided via completion of Table 2
N/A
N/A
The Host organisation must ensure that
LCRN activity is included in the local
internal audit programme of work
3.17
Date of planned audit or anticipated timescale
if exact date not yet known
The Host trust’s internal auditors are KPMG. They have been
provided with all the necessary internal audit guidance by the LCRN.
The COO met with KPMG to agree the scope of the initial audit. This
was carried out in February/March 2015 and the audit report is
awaited.
No further formal internal audit work is anticipated for 2015/16,
unless particular issues or concerns are raised but there will be a
programme of work by the Host R&D Finance department to provide
assurances regarding the accuracy of financial returns received from
Partner organisations
First internal audit
completed and report
finalised
R&D Finance work
programme agreed
By end April 2015
The Cross Divisional and Support Services Team Manager is the link
person for the CRN Study Support Service programme. Information
will be cascaded down via the monthly Operational Management
Group meetings to the other divisions and will form part of the cross
divisional update at each meeting to all Research Delivery Managers.
Information will be cascaded to all trusts via the monthly RM&G
On-going
The Host organisation shall ensure that
all LCRN organisations adhere to
national systems, Standard
Operating Procedures and operating
manuals in respect of research delivery
6.1-6.20
Provide confirmation that the LCRN has a link
person for the CRN Study Support Service
programme and describe how information is
cascaded to relevant colleagues
Activities to be
completed throughout
2015/16
On-going
13
CRN: Thames Valley and South Midlands Annual Plan 2015-16 as specified by the national CRN
Coordinating Centre. The Host
organisation shall ensure that the LCRN
management team provides excellent
study performance management, in line
with the standards and guidance issued
by the national CRN Coordinating Centre,
in order to ensure that all NIHR CRN
Portfolio studies recruit to agreed
timelines and targets.
Manager meetings.
If required, and dependent, on future developments, additional
meetings to discuss the programme of work will be arranged. When
sufficient clarity is available for researchers a separate programme of
engagement will be designed
To ensure that all partner organisations follow the agreed CRN
national systems, Standard Operating Procedures and operating
manuals in respect of research delivery, the following key actions will
be in place-
Provide a brief outline (1-2 paragraphs) of the
LCRN’s plans for implementation and delivery
of the Study Support Service
Provide a summary of expertise and skills that
you have available locally to support
implementation of AcoRD including the
number of individuals able to provide advice
on the attribution of activities in line with the
Attributing the costs of health and social care
Research & Development (AcoRD) guidance1
and a description of the model(s) the LCRN
has used to date in providing advice

On-going oversight by the RM&G Lead Manager (Adeeba
Asghar)

work with trusts to identify any non-compliant processes and
systems

exception reporting to the Executive and Partnership Groups to
highlight any areas of non-compliance, concerns or potential
duplication of activities

The LCRN is committed to the efficient and speedy
implementation of this service building on initiatives already ongoing within the region. We already operate a lead network
function providing a service to chief investigators and study
teams, for particularly multi-site studies, and we will build on this
to deliver the new services required by the CRN. An initial
structure for the provision of these functions by the LCRN has
been prepared for discussion and agreement.

The support services required by local teams and researchers
will be delivered both by staff funded in the local trusts and by
LCRN core team and we will work with partner organisations to
develop our plans in line with the most recent national guidance
from the CRN
Cross Divisional team
structure for the study
support service
Operational plan
agreed by Partnership
group
Transition of core
RM&G staff into Study
support service roles.
By end September
2015
The Thames Valley has two trained AcoRD specialists in addition to
the AcoRD Lead who sits on the national project board for
implementation. The networks is committed to improving the cost
attribution for studies led from the region in line with the AcoRD
guidance, to this end the network:

Engages as early as possible with researchers in the funding
application process to offer initial advice at the initial round of
application supplemented by more in depth support at full
application.

Promotes workshops on cost attribution for researchers with two
presently planned in trusts in the region to increase the general
knowledge base amongst research staff.

Promotes the principle that the cost attribution should be
undertaken once by the Lead Network. Costings undertaken by
other networks will be accepted by the Thames Valley and South
Midlands and reciprocal agreement would be expected.

Engage closely with the finance departments of trusts to
facilitate and mutually agree cost attribution.

Offers a cost attribution service to all researchers irrespective of
funder.

Seeks to engage as widely as possible with all stakeholders to
include RDS, CTU and University colleagues.
1
Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/351182/AcoRD_Guidance_for_publication_May_2012.pdf
14
CRN: Thames Valley and South Midlands Annual Plan 2015-16 The Host organisation will ensure that all
LCRN Partner organisations adopt NIHR
CRN research management and
governance operational procedures.
The Host organisation will ensure that
quality, consistency and customer service
are central to the LCRN’s purpose in the
implementation, delivery and oversight of
NIHR CRN research management and
governance services.
Delivering on the
Government
Research Priority of
Dementia
Patient and Public
Involvement and
Engagement (PPIE)
The Industry Operations Manager will
work closely with the Chief Operating
Officer to establish and enable the
implementation of the NIHR CRN Industry
Strategy within the LCRN. The Industry
Operations Manager will establish and
lead the cross-divisional Industry function,
including the single point of contact
service, within the LCRN. The Industry
Operations Manager will work closely with
each Divisional Research Delivery
Manager across all research divisions to
ensure consistency of feasibility, study
delivery and coordination across all
divisions within the LCRN. The Industry
Operations Manager will be responsible
for the promotion of the Industry agenda
to LCRN Partner organisations and
investigators, delivering aspects of a
national NIHR CRN Industry Strategy
within the LCRN.
6.21
The Host organisation will ensure the
LCRN supports this strategy by:
Identifying and nominating clinical
Research Leads in each of these disease
areas (dementias, Parkinson’s disease,
Huntington’s disease and motor neurone
disease) to support the delivery of the
Dementias and Neurodegeneration
(DeNDRoN) studies on the NIHR CRN
Portfolio through local clinical leadership
and participation in national activities,
including national feasibility review
7.1-7.7
The Host organisation will support the
development and implementation of the
NIHR CRN Strategy for PPIE and deliver
a workplan with measurable targets for
ensuring that patient choice, equality and
diversity, experience, leadership and
involvement are integral to all aspects of
LCRN activity, in partnership across NIHR
CRN.
8.1-8.6
Provide a brief outline of local plans for
supporting CSP BAU activities within local
delivery structures in accordance with POF,
and noting clauses 5.28 & 5.29 when planning
RM&G local delivery structures
Where possible the network will seek to reduce duplication of local
checks. The network currently operates a single network assurance
for all primary care studies which has prepared this area well for the
smooth transition into the HRA.
The monthly RM&G Manager meetings will be used to discuss the
implementation plans of the HRA approval and assessment
processes. These will be attended by the local HRA champion.
It is envisaged that core staff will be transitioned into study wide
activities for the study support service within the Cross divisional
team.
On-going
On-going
Provide an outline for the performance
management of the provision of local
feasibility information (site intelligence and
site identification) for commercial contract
studies. To include action plans for
2
improvement in performance .
The network manages all local feasibility information through a
bespoke tracker which will be revised with the advent of the CPMS
system. Rates of return of site interest and non-return of site
intelligence are monitored on a monthly basis for report to the
Industry Operations Meetings.
The tracker should resolve incidents reported of non-return.
Furthermore:

All non-returns in this financial year will be investigated.

The LCRN tracker data will be fully reconciled with reports
from CRN CC. Our initial review suggests that there are
several data discrepancies between the data from CRN CC
and the local tracker information which indicates significantly
higher response rates than those which have been reported by
CRN CC

Separate meetings arranged with Divisions 1 and 2 to analyse
process flows.
Revision of tracker to
include feasibility
requests sent.
Meetings with
Divisions 1 and 2
1st April 2015 and ongoing
LCRN wide usage and adoption of the NIHR CRN costing template
has been achieved.
Industry Operations
Manager to seek
confirmations from all
trusts
Confirmation by 1st April
2015
Provide details of local strategies for
achieving LCRN wide usage and adoption by
Host and Partner organisations of the NIHR
CRN costing template
Please provide names and contact details for
identified clinical Research Leads for each of
these disease areas
Provide a comprehensive patient and public
involvement and engagement plan in line with
agreed format and guidance
Dementias:
Dr Rohan van der Putt (Rohan.Vanderputt@oxfordhealth.nhs.uk). This is a funded PA
Parkinson’s disease:
Dr Michele Hu (michele.hu@ndcn.ox.ac.uk). This is a funded PA
Huntington’s disease:
TBC, Helen Collins interim (helencollins1@nhs.net)
Motor neurone disease:
TBC, Helen Collins interim (helencollins1@nhs.net)
Provide via completion of Table 4
2
Information on recent performance provided by national CRN Coordinating Centre on 30/01/15 15
CRN: Thames Valley and South Midlands Annual Plan 2015-16 The Host organisation must identify a
senior leader to take responsibility for
Patient and Public Involvement and
Engagement (PPIE) within the LCRN.
The identified lead will participate in
nationally agreed PPIE initiatives and
support the delivery of an integrated
approach to PPIE across the NIHR CRN.
Continuous
Improvement (CI)
Workforce, Learning
and Organisational
Development
Information Systems
The Host organisation will promote and
sustain a culture of innovation and
continuous improvement across all areas
of LCRN activity to optimise performance
Provide the name and contact details for the
senior leader with identified responsibility for
patient and public involvement and
engagement
The Chief Operating Officer of the LCRN (Val Woods) is the senior
leader with responsibility for PPIE within the LCRN whilst a
replacement for Chris Hille is appointed
N/A
N/A
N/A
N/A
Val Woods
Mobile 07776 465940
val.woods@nihr.ac.uk
9.1-9.6
The Host organisation will develop a
workforce plan for LCRN staff that will
enable a responsive and flexible
workforce to deliver NIHR CRN Portfolio
studies. This will be developed in
partnership with Local Education and
Training Boards (LETBs) and other
stakeholders and other local learning
providers, including Academic Health
Science Networks (AHSNs)
10.1-10.10
The Host organisation must ensure that
appropriate, reliable and well maintained
information systems and services are in
place and fully operational as specified
13.1-13.19
Provide an assessment of the LCRN’s current
position in relation to Continuous
Improvement
Continuous improvement is not treated a separate work programme
but as an underlying foundation for the LCRN’s on-going work. The
network has numerous projects and areas of work that come under
the area of continuous improvement. Work is presently underway to
identify and list these on the CRN website.
A continuous improvement working group will be instigated to provide
support to the numerous staff engaged on these activities. The green
belt 6 sigma training will be used to support several initiatives in this
annual plan.
Provide an action plan for promoting and
sustaining a culture of innovation and
continuous improvement across all areas of
LCRN activity, including the LCRN’s approach
to developing capacity and capability of the
LCRN workforce (the latter to be evidenced in
the LCRN’s submitted workforce development
plan)
Provide via completion of Table 5
Provide details of continuous improvement
projects to be delivered locally in 2015-16 (via
CRN Central)
Please submit details by adding to the CRN CI site
Provide a workforce plan in line with agreed
format and guidance
Provide the name and contact details for the
senior leader with identified responsibility for
LCRN workforce development
Confirm LPMS systems are live and
operational as required
Provide via completion of Table 6
Helen Collins
Mobile: 07825 356499
Email: helen.collins@nihr.ac.uk
N/A
N/A
The LPMS options appraisal was presented to OUHT and the
Partnership Group at the end of November 2014. The Group
concluded that we should continue to invest in the Joint Research
Office (JRO) Portfolio System which already has wide scale adoption
in the Host trust and in joint work with Oxford University. We
therefore sought a waiver from the trust's standing financial
instructions to procure LPMS from the existing supplier (Baseline
Software Ltd) on the fair grounds of standardisation and compatibility
with existing service.
Baseline Software Ltd has registered as a LPMS supplier with the
NIHR CRN. They are now extending the JRO Portfolio System to
work across the LCRN and interface to CPMS. They expect to
implement this version in Q1 2015/16
Developing new functionality may take longer. Once CPMS is live,
we build required interfaces between CPMS and LPMS and better
assess the areas where additional functionality is required from
LPMS
N/A
N/A
16
CRN: Thames Valley and South Midlands Annual Plan 2015-16 Engagement and
Communication
Information
Governance
It is the responsibility of the Host
organisation to ensure that there is a
specialist, experienced and dedicated
communications function to support the
work of the LCRN, with a sufficient budget
line. The Host organisation will support
the development and implementation of
the NIHR CRN Strategy for
Communications and ensure that the
LCRN communications function develops
and delivers a local communications
delivery plan that recognises the LCRN’s
position as part of a national system. The
plan should also encompass local
delivery of national NIHR/NIHR CRN
campaigns.
Actively promote and enable good
information governance relating to all
areas of LCRN activity
Confirm arrangements are in place for
provision of an LCRN Service Desk function
and provide contact details
Support for IT systems is currently dealt with by the Host IT
department service desk facility. A series of meetings has also held
with Host organisation to explore the establishment of a separate
‘CRN service desk’ which would triage all LCRN-related calls relating
to Host systems, any other local solutions used by the LCRN and the
new LPMS system through a single system, the performance of
which would be monitored by the LCRN Information Systems
Manager. This is scheduled for further discussion at the forthcoming
LPMS Steering Group meeting in April 2015 and would be
implemented once the LPMS has been fully rolled out across the
region
N/A
N/A
Provide the name and contact details of the
identified lead for the Business Intelligence
function
Dr Mark Dolman
Mobile 07776 477724
mark.dolman@nihr.ac.uk
N/A
N/A
N/A
N/A
14.1
Describe the dedicated communications
function the LCRN has in place
The LCRN has 2 PPI and Communications Managers who support
initiatives across all areas
A senior lead is currently being appointed to provide leadership for
this area to maximise opportunities to communicate and engage with
internal and external stakeholders across the region more effectively
14.2
Outline up to 5 priorities/priority activities
contained in the LCRN’s local
communications delivery plan
Establish a high level PPIE Reference Group with input from across
the region/Specialties/trusts to help develop, deliver and oversee the
LCRN’s communication and engagement plans
Develop a new internal engagement programme to address gaps left
by the transition to the new LCRN governance structures and capture
opportunities to network more creatively across the region
Develop and implement an effective communications strategy across
all media which spans across all 3 counties and aligns better with
communication strategies with other local networks and trusts (e.g.
BRC, BRU, CLAHRC)
Produce a comprehensive plan for the development, distribution and
usage of promotional materials to promote the activities of the
network
Implement a specific communications plan to target awareness
raising of the LCRN’s activities across all primary care settings
14.3
Budget line identified in Annual Financial Plan
for 2015-16
15.2
Provide the Information Governance Toolkit
2013-14 (version 11)3 score for the LCRN
Host organisation and confirmation of
attainment of Level 2 or above on all, or any
exceptions which arise from or impact on
LCRN-funded activities
Final 2013/14 score of Host organisation was 86%, which equates to level 2 attainment overall. Confirmation received that
all requirements met this level of attainment.
15.5
Provide a copy of the LCRN’s documented
process for reporting information governance
incidents arising from LCRN-funded activities
to the national CRN Coordinating Centre
Please submit as Appendix 2 to your plan
15.8
Provide the name, email address and contact
number(s) for the individual with specialist
knowledge of information governance
identified to respond to queries raised relating
to LCRN-funded activities
N/A
Progress on all
activities to be reviewed
at end of March 2016
N/A
Dr Christopher Bunch
Consultant Physician and Caldicott Guardian Oxford University
Hospitals NHS Trust
chris.bunch@ouh.nhs.uk
01865 221343
N/A
N/A
N/A
3
https://www.igt.hscic.gov.uk/ 17
CRN: Thames Valley and South Midlands Annual Plan 2015-16 15.9
Provide details of information systems utilised
in LCRN activities and assurance/evidence
that these are in line and comply with the
2013 NIHR Information Strategy4
Information systems used by the network include RDMIS, Open Data
Platform, SharePoint and the hub/Google platform. The network is
actively seeking to progress to the national service offering of the hub
and is project planning migration of all shared e-mail addressed to
NHS net and all files currently stored on host shared drives will be
migrated to the Google Platform during the course of Q1/Q2 2015/16
financial year. Host shared drives will then be decommissioned The
network preferentially accesses the hub whenever possible and
supports the movement of central documentation from SharePoint
files to the hub and the eventual decommissioning of the former.
ODP is seen as a vital resource for the network and wider access is
recommended to the wider research community working on portfolio
studies.
N/A
N/A
4
https://docs.google.com/a/nihr.ac.uk/file/d/0B6w0JTB5jHBSSldZT0Qyc05lVms/edit?usp=drive_web
18
CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 4: LCRN Patient and Public Involvement and Engagement Plan 2015-2016
Planned actions in 2015-16
Milestones and outcomes once actions complete
Timescale
Lead
Promote research opportunities in line with the
NHS Constitution and inform patients about local
research opportunities
Key actions-
Milestones-
Hub/websites established to promote participation
in research opportunities and PPIE campaigns
Project plan developed and sites set up. Guidance on
usage and promotional activities in place
By end Q2
2015/16
Information Systems
Manager and Lead
Communications and
Engagement Manager
Promote patient stories in local and national press,
newsletters and other media
Develop/promote at least 10 patient studies for local
and national use
By end Q4
2015/16
Communications and
Engagement Managers
Social media strategies revised to improve
information available for patients/carers and public
regarding opportunities for involvement and
participation
Revised strategy agreed and actions in place
By end Q4
2015/16
Lead Communications
and Engagement
Manager
Promote OK to Ask across the region
Active engagement by members trusts in campaign
with follow-on publicity
May 2015
Communications and
Engagement Managers
LCRN annual event to be focussed on PPIE
PPIE Groups involved in developing agenda and
running event
November 2015
COO
Strengthen links with trust Communications and
PPI departments to maximise opportunities to raise
awareness and develop collaborative approaches
to engagement
Each trust department contacted and approaches for
promoting activities jointly developed and agreed
By end Q4
2015/16
Lead Communications
and Engagement
Manager
Outcomes

Patients, carers and the wider public better
informed about our activities
PPIE further embedded as core business in work
of LCRN and CRN
19 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16
Milestones and outcomes once actions complete



Timescale
Lead
Raising our profile and reputation
Increase in demand for, and participation in,
research studies
Improved collaboration with stakeholders
Actively engage and involve patients, carers and
the wider public in all aspects of the LCRN and
wider research endeavours
Key actions-
Milestones-
Ensure that PPIE is embedded in development and
approval of key LCRN strategies, plan and reports
PPIE representatives on Partnership Group are
routinely consulted on key plans, reports and
strategies
By end Q1
2015/16
COO
Establish PPIE Oversight Group for the LCRN with
membership drawn from Partnership Group patient
representatives and those involved in other aspects
of the LCRN’s activities to help LCRN to develop
and oversee delivery of PPIE initiatives and plans
and foster stronger culture of collaborative and
joined up working
Formal meetings held with Oversight Group and ToR
agreed
By end Q2
2015/16
Lead Communications
and Engagement
Manager
Continue to provide support to local engagement
groups within specific disease areas
Active local groups supported from core team on ongoing basis for Cancer, Diabetes and DeNDRoN
specialties
ongoing
Communications and
Engagement Managers
Complete current work with AHSN, BRC,BRU,
CLAHRC, trusts and other groups within the region
to provide comprehensive and streamlined
approach for PPIE activities with clear signposting
for patients, carers and members of the public
Signposting/roadmaps in place and promoted across
region
By end Q2
2015/16
Communications and
Engagement Managers
Produce common expenses policy for region-wide
use by above groups
Implemented for consistent use across region (where
possible)
By end Q2
2015/16
COO
20 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16
Develop specific approach for PPIE activities within
primary care settings
Milestones and outcomes once actions complete
Extended lines of communication within Primary
Care (including CCGs) with specific
engagement/promotional programme in place
Timescale
Lead
By end Q2
2015/16
COO
Outcomes



LCRN strategies and plans are better informed
as result of PPIE input
Stronger patient voice with wider ‘reach’
Stronger alignment and commitment with regard
to PPIE activities from stakeholders across the
region
System-wide approach with more consistency
(e.g. expenses)
Gather feedback from participants in studies as
well as patients, carers and the public, directly
involved in supporting study delivery
Key actions-
Milestones-
Complete develop of patient experience
questionnaire for participants in studies to provide
feedback on regularly basis
Questionnaire(s) approved and in use in at least
50% of trusts
By end Q4
2015/16
Lead Communications
and Engagement
Manager
Ensure that Patient / carer case studies and stories
are gathered, collated and analysed on an on-going
basis and captured in communication activities.
Contribute to the national CRN ‘Patient Stories
Campaign’
Develop/promote at least 10 patient studies for local
and national use
By end Q4
2015/16
Communications and
Engagement Managers
Participate in region-wide project (chaired by
AHSN) to develop a common understanding and
shared approach to PPIE recording & impact in the
region
As per project plan (still in development)
TBA
Communications and
Engagement Managers
Create further opportunities for participants to
provide feedback and general comment on the
LCRN’s activities and ensure that feedback is
Ensure that Twitter accounts etc. are active across
region and that all PPIE communications and
promotional activity contains easy-to-use details for
By end Q2
2015/16
Communications and
Engagement Managers
21 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16
appropriately acknowledged (already in place with
Cancer and Diabetes LCRN patient groups).
Milestones and outcomes once actions complete
Timescale
Lead
contacting the LCRN and acknowledging
contributions
Outcomes



PPIE feedback is properly valued
LCRN strategies and plans are better informed
as result of PPIE input
Drives culture of continuous improvement
Stronger patient voice
Count how many actively involved patients, carers
and the public access NIHR CRN learning and
development resources
Key actions-
Milestones-
Attendance at specific training events measured
and feedback collected
Metrics reported to Partnership Group meeting
By end Q4
2015/16
COO
Develop, promote and measure access to ELearning opportunities, to include national and
LCRN initiatives (e.g. building on LCRN workforce
induction and development programmes)
Initial E-Learning modules available and process in
place to measure take-up rates
By end Q2
2015/16
COO
Capture attendance metrics from all other events
and meetings that involve PPIE (including those
that are managed by core LCRN team and those
supported by network members across the region
Metrics being collected on regular basis and analysis
shared with Partnership Group
By end Q4
2015/16
Lead Communications
and Engagement
Manager
Complete induction programme for newly
appointed patient representatives on Partnership
Group
Process completed and feedback collected
By end Q1
2015/16
COO
Survey patients, carers, the public and our
researchers to identify further learning &
development needs and opportunities
Survey distributed to all contacts and feedback
analysed
By end Q3
2015/16
Lead Communications
and Engagement
Manager
22 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16
Milestones and outcomes once actions complete
Timescale
Lead
Outcomes

Success can be properly measured
Supports continuous improvement in quality and
scope of resources

Values PPIE involvement and feedback
Support the development and implementation of
the national NIHR CRN Strategy for PPIE
Key actions-
Milestones-
Update this PPIE plan and align with NIHR CRN
strategy once the national strategy been approved
LCRN strategy updated and discussed at
Partnership Group meeting
By end Q3
2015/16
COO
Ensure national strategy is circulated widely across
stakeholders and can be accessed easily
Strategy available on intranet and internet websites,
circulated to all PPIE contacts and shared with
regional groups
By end Q2
2015/16
COO
Promote the ‘NIHR Patient Research Ambassador’
initiative
50% of trusts to have adopted ‘Patient Research
Ambassador’ initiative and embedded the approach
within their organisations
By end Q4
2015/16
Lead Communications
and Engagement
Manager
Appoint Lead Communications and Engagement
Manager to engage in national initiatives
Recruitment Process complete and manager in post
1 September
2015
st
COO
Outcomes



Enables best practice to be developed, shared
and implemented
Drives culture of continuous improvement
Strengthens patient voice
National and local strategies and plans will be
better informed

Improves collaboration and consistency
23 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 5: Continuous Improvement Action Plan 2015-2016
Planned actions in 2015-16
Milestones and outcomes once actions complete
Timescale
Lead
Scoping of all continuous improvement projects and
initiatives throughout Cross Divisional team and all
Divisions
Item for the Operational Management Group meeting.
Research Delivery Managers requested to supply details
May/June 2015
Harriet Savage
Recording all continuous improvement projects on the
national website
Dependent on previous action
30/6/15
Harriet Savage
Training of 3 staff for green belt Lead Six Sigma.
Attaining national training. Identification of appropriate
projects
31/5/15
Mark Dolman
Completion of a Cohesive network continuous
improvement strategy for the Thames Valley and South
Midlands
Consultation with continuous improvement group.
Consultation with Trusts
Strategy for sign off by partnership group
30/10/15
Mark Dolman
Establishment of a system for monitoring and
registering new continuous improvement projects in
order that the benefit can be realised comprehensively
across the network and duplication minimised.
To be driven by continuous improvement group
30/6/15
Harriet Savage
Analysis of overlap and inclusion of Workforce
Development in any strategic operations.
Discussion in workforce development meeting
On-going
Harriet Savage
Establishment of a continuous improvement group with
ToR for the network
Representatives to be sought from all divisions and cross
cutting team
30/4/15
Mark Dolman
Sourcing of a standard suite of project management
documentation to be used for continuous improvement
National advice and availability sourced in the first
instance. Correct branding added before availability
31/7/15
Harriet Savage
24 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Table 6: LCRN Workforce Plan 2015-2016
Planned actions in 2015-16
Milestones and outcomes once actions complete
Timescale
Lead
Delivering network business
Consolidate and deliver Induction
programme
Webinar delivery – each month, effective Feb 15. Keep
updated and review in light of evaluation
IT training – include as part of programme by June
2015. Look at webinar format
Working in the CRN workshop
Meet and Greet: finalise signposting document, then
formulate Meet and Greet plans
Every month
NIHR hub, CPMS, LPMS, excel
training – start delivering by June
2015, and monthly thereafter
depending on need
Roll out as per local need, likely to
be 1 in every 6 weeks, once
backlog has been cleared
By July 2015
Helen Collins/Nancy
Hopewell
Delivering network business
Deliver Fundamentals of Clinical Research
Nursing
Subject to quality of training materials delivered by the
national team, deliver first 2 day course 25/26 March.
Deliver to RNs who have been in post <18 months
Roll out as per local need, likely to
be 1 in every 8 weeks, once
backlog has been cleared
Nancy
Hopewell/Sally Beer
Delivering network business
Deliver Fundamentals of Clinical Research
Develop local training to ensure equity of training
opportunities across local workforce
Aim to finalise material/format by
November 2015, then roll out
according to local need thereafter
Helen Collins + TBC
Regulation and Safeguarding
GCP programme
Introduction to GCP version 3 to be piloted 8 April 2015,
then GCP facilitators trained locally on 22 April 2015,
then rolled out across region
Refresher GCP course: national update planned for late
2015. Implement changes locally as per national
timescales
PI GCP: awaiting national launch. Implement changes
locally as per national timescales. Local clinical director
is keen to use this to support PI engagement
April 2015
As per national timescales
As per national timescales
Nancy Hopewell
and local GCP
facilitators, + Dr
Belinda Lennox
Regulation and Safeguarding
Valid Informed consent
Review current local course and update
By September 2015
Nancy
Hopewell/Sally Beer
Delivering network business
Let’s Talk Trials
2-3 facilitators to attend national training in June/July
2015
Develop Roll out programme to
start in October 2015
Nancy Hopewell
25 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Planned actions in 2015-16
Milestones and outcomes once actions complete
Timescale
Lead
Speciality specific and Responsive
Specialty specific courses
Rater training; Cancer Researchers Introductory course
Continue to support these national
programmes
Helen Collins –
rater;
Nancy Hopewell Cancer
Speciality specific and Responsive
Specialty specific courses
Continue to run where courses are available
Develop and run Training needs analysis survey to
inform Specialty specific learning
Develop survey questions – May
2015
Open survey and collate/report
results – July 2015
Each division to develop WFD
strategy – by September 2015
Helen Collins, Tess
John, David Porter,
Nancy Hopewell
Delivering network business
Team building for core network team
Using “Working in the CRN” materials and other
facilitators, develop and deliver core team building
sessions
Refine content from December
2014, and deliver in April and
September 2015
Val Woods/Nancy
Hopewell
26 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 Appendix 1: LCRN Risk Register NIHR Clinical Research Network Risk Register March 2015 Owner of LCRN Risk Register: V Woods, Chief Operating Officer, LCRN Updated: 24 February 2015 Next Review: May 2015 Scoring legend 1 2 3 4 5 Likelihood Over 12 months: Rare Over 12 months:
Unlikely Within 3 – 12 months: Possible Within 3 months:
Likely Within 3 months:
Almost certain Consequence Insignificant Minor Moderate Major Catastrophic Risk Score (on averaged
basis for all risks listed)
Risk Level >15 8 ‐ 14 4 ‐ 7 1 ‐ 3 Extreme Risk
High Risk Moderate Risk Low Risk Inherent (gross) # CRN1 Risk Description Uncertainty around requirements for new study support service as HRA introduced Likeli‐
Impact hood (1‐5) (1‐5) 4 3 Residual (net) Consequence of Failure to Manage Risk Activities to Reduce/Eliminate Risk (a) 12 Could be both operational and reputational risk to LCRN If a ‘quick start up’ approach is adopted by HRA before all systems/processes have been developed, there is a real risk of confusion for researchers 



Likeli‐
hood Impact (1‐5) (1‐5) Risk Control Score (b) (a‐b) Responsibility monitor new requirements closely and plan workloads well ahead, reviewing level of resource as necessary keep Executive Group updated on any issues work with CRN CC on new arrangements work closely with HRA local Champion (Janet Boothroyd) 4 2 8 4 Cross Divisional Manager re‐advertise roles if necessary advertise more widely than NHS jobs if required to improve quality of candidates applying for roles Work with Host trust on retention policies/enhancements 4 2 8 7 Cross Divisional Manager Could destabilise and demotivate work teams CRN2 Cannot recruit or retain good staff due to high cost of living and low unemployment in the region 5 3 15 Impact on resilience of LCRN Ineffective career planning Demotivating for existing staff due to work pressures 


26 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 CRN3 Continuing complexity in metrics and on‐going differences between metrics for DH and CRN 5 3 15 Lack of LCRN buy in with trusts if focus on DH metrics and not CRN ones 


work with CRN CC on concerns continue to highlight at national meetings develop effective systems for collecting data locally (eg LPMS) to meet all requirements 4 2 8 7 Cross Divisional Manager 

work with CRN CC further work with local stakeholders (LAT, CCGs) 4 2 8 7 Cross Divisional Manager deliver primary care strategy Strengthen links with GP groups – especially outside Oxfordshire closer working with LAT 3 2 6 4 Clinical Lead/RDM for Division 5 better use of data to understand and performance manage improve processes for supporting follow up consider direct taskforce 3 2 6 4 Clinical Lead/RDM for Division 1 deliver industry strategy work collaboratively across the region with other NIHR funded bodies close working with Partnership Group better use of data to understand and performance manage hold regional industry conference 3 2 6 4 Cross Divisional Manager May reduce effectiveness of monitoring of performance against time to target and first patient visit Too much time diverted to debates on how performance is measured rather than focusing on problem solving CRN4 Cannot agree policy for ETC 5 3 15 Cannot run studies Reputational risk CRN5 Primary Care recruitment below national average 5 2 10 Not achieving potential in the Thames Valley & South Midlands region 

Not meeting national objectives 
Losing momentum on Primary Care research CRN6 Cancer recruitment below national average 5 2 10 Not achieving potential in the Thames Valley & South Midlands region Not meeting national objectives 


Losing momentum on Cancer research CRN7 Industry performance is below national average 5 2 10 Not achieving HLOs Not achieving potential in the Thames Valley & South Midlands region Not meeting other national objectives Reputational damage and missed opportunities 




Impact in terms of RCF funding which further limits ability to grow commercial portfolio 27 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 CRN8 Ineffective implementation of Google platforms and hub 4 2 8 Lack of awareness of CRN activities 
Not using Hub to full potential or in line with national expectations 
implement action plan to develop hub working locally work with CRN CC on technical issues 3 2 6 2 Cross Divisional Manager hold meetings of LPMS Steering Group and Project Group as soon as CPMS implemented, agree scope of additional functionality required and build necessary interfaces asap 5 1 5 5 Chief Operating Officer make guidelines clear signal early what can and can’t be done more work to consider costings at study development stage so that realistic expectations and common understanding can be set very close operational management of budget
retain contingency fund if possible to address urgent requests closer work with OUH R&D Finance to develop stronger systems that incorporate all funding sources (BRC, RCF, commercial, Grant etc) in decision making 2 2 4 5 COO/RDMs/Cross Divisional Manager discuss plans for new chair at next meeting once in place, schedule meetings well in advance vary format to make meetings attractive and opportunities to showcase achievements 2 2 4 2 Chief Operating Officer work with OUH chief nurse on updating and co‐coordinating policies and approaches for attracting, retaining and developing research and clinical roles provide support through CRN workforce development initiatives 2 2 4 2 Chief Operating Officer Unable to access up to date information CRN9 LPMS implementation will over run into 2015/16 5 2 10 Will not meet CRN objectives Reputational risk 

CRN10 Requests for SSC funding on new studies will outstrip ability of CRN to commit financial support, particularly moving into 2015/16 3 3 9 Operational and Reputational risk Missed recruitment opportunities 





CRN11 Partnership Group meetings may not meet all CRN objectives 3 2 6 Difficulties in making meetings all quorate 
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Difficulties in scheduling 4 x meetings 
per year Chair is stepping down CRN12 Cannot fill posts or retain research staff in OUH due to fixed contract length whilst at same time there are trust concerns that availability of research posts in OUH may be impacting adversely on their ability to retain staff in clinical posts 3 2 6 CRN cannot attract or keep experienced staff 
Leads to disruptive staff turnover OUH cannot retain sufficient cover in clinical posts 
Policies for research staff and clinical staff are not in alignment 28 CRN: Thames Valley and South Midlands Annual Plan 2015‐16 CRN13 Insufficient space available at Churchill sites for research staff 3 2 6 Cannot run studies if no space so impacts on delivery of recruitment objectives ‐raise at Executive Group meetings Adverse impact on team morale ‐offer ‘hot desk’ space in network office at NOC 2 2 4 2 Chief Operating Officer 2 2 4 4 Chief Operating Officer ‐arrange meetings of all relevant stakeholders on Churchill site to find better solution Staff leave due to poor working conditions CRN14 Implications of LCRN policy not to fund Clinical Delivery PAs in 2015‐16 4 2 8 Clinician’s unable to source funding from other sources or embed in job plans Could impact upon morale Couple impact on study delivery ‐raise at Executive Group meetings ‐improve internal communications with Divisional RDMs and Clinical Research Leads to flag up and address potential issues at an early stage ‐explore solutions and best practice from other LCRNs 29 CRN: Thames Valley and South Midlands Annual Plan 2015-16 Appendix 2: LCRN Process for Reporting Information Governance breaches to the CRNCC
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