-
Healthcare research study: College‐sponsoredIC
HT
Div
isio
nsCI
/PI (
SID
st
udy
team
)JR
O
(fun
ding
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CO
(spo
nsor
)Su
ppor
t se
rvic
esEx
t. o
rgs
30 calendar days
GOVERNANCE RECRUITMENTWORK‐UPFEASIBILITY
Confirm sponsorshipArrange peer reviewReceive valid IRAS Check
internal approvals Monitor trial
Check external approvals
Issue Trust approval
Project initiation
Review amendments
Develop proposal
Assess feasibility
Apply for funding
Initiate site and recruitment
FPFVClose site
Coordinate work‐up
Submit to IRAS
Run governance checks
Issue Trust permission
Advise costs / feasibility
Prepare grant / contract
Process service request
Work‐up award
Issue approvals, eg REC
Activate funding
Confirm service approval
Confirm funding
Develop protocolAssess feasibility
Apply for funding
Divisional review
Assess costing
Coordinate study work‐up
Approve IRAS submission
Submit forms to IRAS
Prepare documentationInitiate recruitment
Capture accrualsClose site
Report / archive / publish
Reaffirm feasibility
Finalise study logisticsBrief trial teamPlan study logistics
Confirm portfolio eligibility
30 calendar days
DAY 30: R&D approval DAY 60: First patientDAY 0: IRAS
Submission
Overview Thursday, 16 July 2015
(c) Imperial College London College-sponsor-process-v13 no
links
-
Healthcare research study: College‐sponsoredJR
O (f
undi
ng)
JRCO
(s
pons
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Supp
ort
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ices
Ext.
or
gsCI
/PI (
SID
st
udy
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HT
Div
isio
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Feasibility Work‐up
Feasible?
REVIEW
Review costing (InfoEd)
Develop protocol
RETURN TO MAP OVERVIEW
Work‐up process
>>>
Divisional review
Decision Station (task)
NO
Enter on Documas
Confirm sponsorship
Submit funding application
Cancel study
Advise service costs / feasibility
Complete funding
application
YES
Approve grant application
Assess feasibility
Cost service agreements
Assess resources / capacity
Assess costing (create InfoEd)
Negotiate contract / agreements
Confirm portfolio eligibility
Milestone
Develop research
idea
Feasibility Thursday, 16 July 2015
(c) Imperial College London College-sponsor-process-v13 no
links
http://www3.imperial.ac.uk/jointresearchoffice/clinicaltrialsprocess/stagesandstations/feasibilitystage/developresearchidea
-
Healthcare research study: College‐sponsoredJR
O
(fun
ding
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CO
(spo
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Div
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t. o
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CI/P
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Work‐upFeasibility Governance
LOCALPI submits SSI (IRAS)
Log receipt (valid
submission)
Process request for services
Arrange peer review (if reqd)
STUDY‐WIDECI submits REC /
R&D (IRAS)
Coordinate study
work‐up
Prepare to hire study staff
Governance process
>>>
Feasibility process
-
Healthcare research study: College‐sponsoredEx
t.
agen
cies
JRO
(f
undi
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JRCO
(spo
nsor
)Su
ppor
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rvic
esIC
HT
Div
isio
nsCI
/PI (
SID
st
udy
team
)GovernanceWork‐up Recruitment
20 days
Log receipt (valid
submission)
Initiate governance
review
Approve trial?
SUSPEND NO
Issue Trust approval
YESComplete
governance review
Issue approvals, eg REC / MHRA /
ARSAC
Confirm contract / finance
Confirm service approvals
Check policy / procedure / legal reqs
30 calendar days
Brief trial team
Recruitment process
>>>
Work‐up process
-
Healthcare research study: College‐sponsoredEx
t org
sIC
HT
Div
isio
nsJR
O
(fun
ding
)JR
CO (s
pons
or)
Supp
ort
serv
ices
CI/P
I (SI
D
stud
y te
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Governance Recruitment
30 calendar days
20 days
Initiate recruitment
Monitor and oversee trial
Activate funding
Capture subject accruals (End of
Treatment)Close site
Governance process
