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Sheffield Teaching Hospitals NHS Trust

Clinical Research Offi
ce

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Clinical Research Office and CReST (Clinical Research Systems Team)

Informatics Program


1.

Brief Introduction

The rationale for funding the CReST research informatics program, and the aspirations
behind its inception, are primarily
to support the growth of
research

in Sheffield

by

expand
ing

our research portfolio

and

improving Sheffield’s
national and international
reputation in Clinical Research
.

Research

Strategy

STH
participates

increasingly in

research activities with a strategic emphasis. Whilst
program
mes of research have long played a part in many Directorates’ goals, the granting of
several large programme grants, the establishment of the
Sheffield
Cancer Research Centre
and the successful

Clinical Research Facility NIHR Experimental bid award are

a m
ajor
endorsement of Sheffield’s combined academic and clinical strengths in designing
future
world leading

research architectures and infrastructure.


An often under
-
appreciated part of such an infrastructure is the comprehensive data
acquisition, storage
and transport facility needed to ensure that the highest possible data
quality is established and maintained
. It is a requirement that the

processing of
this
data
for
anonymised research take
s

place safely, securely and seamlessly within

routine clinical
p
ractice. These data

systems are not standardised

and

must integrate
for data interpretation
locally
. This integration process is a core
function

of the
CReST team.

Regulatory Research Support

Scrutiny of research processes by regulatory authorities
makes
r
esearch conduct an
essential
.
This research must be

set up and managed in accordance with the various
regulatory requirements in a timely streamlined fashion to increase the number of research
studies set up in Sheffield. Once a study is set up, there need
s to be the infrastructure to
ensure effective

study

management

and metric reporting.


2.

Research Informatics Systems in development


The
CReST
team
are currently developing/implementing a number of Research Informatics
systems to facilitate Clinical study s
et up and management in Sheffield.


a)

PHinD

(
Patient Integrated Datastore
)

PHInD is a data querying system based on the i2b2 system developed by Harvard University.
STH has significantly re
-
engineered it to deal with very large volumes of data and we are
cu
rrently i
nserting data from all core systems.

This will allow the trust for the first time to run queries across all of these systems in a few
seconds. More importantly in the context of cohort identification it also allows us accurately
assess the exclusi
on criteria which are often specified in clinical trials. This system, whilst
developed for research purposes, clearly has applications in other areas of the trust such as
audit and service improvement and we will be working over the next 6 months to estab
lish
the governance framework for accessing the system.


b)

Clinical Systems

Based on an internally developed database management system we are currently engaged
with the academic directorates to roll out clinical data management systems to support both
clin
ical research activities and service provision. The overriding philosophy of this activity is
that unless the system used is of clinical value and brings benefits to those using it the data
Sheffield Teaching Hospitals NHS Trust

Clinical Research Offi
ce

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quality will be poor and therefore the research value will be poor
. We seek to integrate with
existing systems where possible and bring added value to routine clinical data with advanced
information management. ArQ comes with facilities to integrate with ICE, PACS, Outpatient
clinic lists to name a few, and has an analyt
ics interface that let users run complex queries
and export results into numerous formats for further analysis.


c)

Clinical Research Office Systems

i)

There is a new
Research Management System (RMS
) in development to

streamline
research governance approval for

studies and facilitate
study set up.
Work has been ongoing on this system since Mar 2012 and go
-
live date is
currently estimated to be end of April 2013.

ii)

A

new web based document repository
,
Alfresco
,

came into use on the 1
st

July
2012

for storage of stud
y documents. Alfresco is
now in use

for more effective
document sharing
,
introducing

document version control.

iii)

The introduction of
Edge
, a
n externally purchased

clinical trial management
software
,

is currently scheduled for installation in

May

2013
,

which
will facilitate
patient tracking through clinical trials and also accurately record patient accrual
into studies.


Note;

The
three

systems, whilst independent will all be accessible

through the new
Research
Management System (RMS).


3.

Organisational charts

Please see appendix 1.


4.

Roles & Responsibilities

Please see appendix 1.


5.

Reporting lines and A
ccountability

Please see appendix 1.






Sheffield Teaching Hospitals NHS Trust

Clinical Research Offi
ce

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APPENDIX 1


CRO Executive
Chair (Simon Heller)
Academic
Clinical
databases
PHiND
Project Manager:
Steven Wood
Research
Management
System
Alfresco
Document
Repository
E
-
dge
Accrual and
Tracking System
LEAD:
Jen Boston
LEAD:
Ramila Patel
LEAD:
Dipak Patel
Project Manager:
Jen Boston
Research Informatics Executive
Chair (Wendy Tindale)
CRO Informatics Project Group
Chair (Jen Boston)
Research finance
systems
LEAD:
Keith McCormack
Grant Profile:
Lydia Harris
Industry Process:
Tanya Loughran
Grant Process:
Jen Boston
Research Informatics Implementation Manager
Steven Wood
Intelligence
Function
LEAD:
Lydia Harris
Martin
Collins
Lyndsey
Grievson