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JRO CTIMPs risk assessment
Section 1: Administrative Information
Title of Proposal:
Short Title:
UCL sponsor number:
Chief Investigator’s Name:
Employer:
Sponsor Regulatory Advisor/ATMP
Regulatory Manager:
Date of Risk Assessment (RA):
If amendment to initial RA indicate new
date and area(s) where risk has changed
(add additional rows, if required)
Date:
Changes in section/question No:
Date:
Changes in section/question No:
Please tick the level of risk involved, either high medium or low;
Risk Management Plans – complete this column with a brief plan to eliminate or manage the risk, if medium or high, should be given, and to
what or whom the risk is (subjects, staff, trial outcome, regulatory, organisation, budget) if considered necessary. Please state if no adequate
risk management plan can be devised. Include monitoring mitigation where applicable, for e.g., increase in number of on-site visits, identifying
triggers for on-site visits, increase in frequency of compliance forms completion, or visits for additional training
If there is substantial amendment that is likely to affect to a significant degree, the safety or integrity of patients or the management of the trial,
there may be a need to re-assess the risk assessment of the trial.
Where indicated; multiple risks in the same category may be listed, e.g. if there is more than one IMP each one must be listed in the
appropriate category.
If a question cannot be answered please state not known and assign the highest risk category.
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Area of Risk
Risk Management Plans
Section 2: Chief Investigator and Resources
1) Peer review
High
No peer review/insufficient evidence of peer review
Medium
Internal peer review
Low
External peer review
High
2) CI experience
Medium
Low
Experienced CI
High
Never completed GCP training or last GCP training
completed before implementation of CT regulations
(1 May 2004)
Low
Completed previously (post 1 May 2004)
High
No experience of using one or more of the
investigational medicinal product(s) (IMPs)
3) GCP Training
4) CI experience of IMP
(where use implies: handling,
administration and familiarity with safety
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Has no experience of being CI or PI on any clinical
trial.
Has no experience of this trial phase if trial is phase I
or phase I/IIa
Has no experience of being CI or PI on noncommercial trials
Has experience of being CI or PI, but no experience
of running multiple site trials (where the proposed
trial is multi site)
Has limited experience of being CI or PI on this trial
phase or in non-commercial trials
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Area of Risk
profile of the IMP(s)), (if more than one
IMP is to be used in the trial, please list
all IMPs and state IMP name in risk
management column)
5) Involvement of other (non-IMP) study
interventions which are high risk/novel
procedures eg surgical, (please state
intervention in risk management column)
6) Trial costing and funding
Any trial that falls into the medium or
high category in this question must
be referred to SOC.
Medium
Risk Management Plans
Has treated less than 50 patients with one or more of
the IMP(s)
Low
Extensive experience (ie treated 50 or more patients)
in use of all of the IMP(s) used in the trial.
High
No experience of using the study intervention
Medium
Limited experience with study intervention (ie use in
less than 50 patients)
Low
Experienced in use of study intervention (ie use in 50
or more patients)
High
No funding or minimal funding
Not costed by JRO
Medium
Costed by JRO but not received all funding
Low
Costed by JRO and fully funded
High
>200 patients
Low
<200 patients
High
>5 years
Medium
2-5- years
Low
<2 years
Section 3: Trial Size and Sites
7) Total number of patients planned?
8) Anticipated total trial duration?
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Area of Risk
9) No. and location of planned sites?
10) Does the JRO have previous
experience of running trials at the
planned site(s)?
11) National or International?
12) If international, number of countries
outside UK?
High
>5 sites
Medium
2-5 sites
Low
1 site
High
Site/facility not known to UCL
Medium
Mixture of known and unknown sites
Low
Sites well known to UCL
High
International outside EEA
Medium
International within EEA
Low
National UK
High
>1
Medium
1
Risk Management Plans
Section 4: Trial Design and Complexity
High
Human Pharmacology (First in man) (Phase l)
Safety and dose ranging study (Phase I/IIa)
Therapeutic exploratory (Phase ll)
13) Phase of Trial
Medium
14) Number of arms
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Therapeutic confirmatory (Phase lll)
Low
Therapeutic use (Phase lV)
High
Medium
4 or more
2-3
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Area of Risk
15) Randomisation
16) Have randomisation
personnel/system been set-up/identified?
17) Blinded trial
Low
Medium
1
Yes
Low
No
Medium
Internal system
Low
Validated external system
Not applicable
High
Yes
Low
No
High
Internal system
24 h external system requiring input from trial team
(eg use of web based system)
Validated external system
Medium
18) Has an unblinding system (24 h
system) been set up/identified?
Low
Risk Management Plans
Not applicable
High
Yes
Low
No
19) Cross Over design
Study conducted in USA or Canada or its
jurisdictions.
High
Trials meeting criteria for an insurance waiver as per
sponsor SOP S28 on insuring clinical studies.
20) Insurance cover considerations
Study with Sites outside the UK (other than US and
Canada)
Medium
UCL to act as legal representative but required to
provide insurance cover.
Study with Sites outside the NHS or intention to enrol
private patients
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Area of Risk
Low
Risk Management Plans
None of the above
Subjects are ‘healthy’ volunteers not patients
Vulnerable adults
Pregnant or nursing women
High
Patients incapable of giving consent personally
Patients in emergency situations (e.g. unconscious)
21) Risks associated with the subject
groups
Children under 16 years of age where interventions
are not standard of care
Women of Child bearing potential (no contraception
requirement in protocol)
Patients with poor prognosis/terminal disease
22) Will a medical device be used in the
trial?
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Medium
Subjects are patients with capacity, but with
comprehension or cognition difficulty e.g. certain
neurological conditions, early dementia
Low
None of above
High
Non-CE marked trial device
Medium
CE-marked trial device
Low
No device to be used
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Area of Risk
High
23) Will any NIMPs be used in the trial?
Low
Risk Management Plans
NIMP(s) has/have no marketing authorisation within
EU.
NIMPs to be used have marketing authorisation
within UK and to be used as per SmPc
No NIMPs to be used
Section 5: Trial and Data Management
24) Is there a CRO or an external Clinical
Trials Unit supporting the management of
the trial?
25) Is data being transferred outside of
UCL?
26) If answered yes to previous high risk
category, is the identifiable data being
transferred outside the UK?
27) Is sensitive patient data being
collected?
High
Yes
Low
No
High
Yes, identifiable data to be transferred
Medium
Pseudo anonymised data to be transferred
Low
No data to be transferred, or anonymised data only to
be transferred.
High
Yes, outside the EEA
Medium
Yes, outside the UK but within EEA
Low
No
High
Yes
Low
No
High
Unlikely to be in place at the start of the trial
Medium
Some; have begun to consider software, security and
QC process.
28) Is there a data management plan?
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Area of Risk
29) Samples to be transferred outside
site
30) Are there any third party vendors or
central service providers (where multiple
vendors will be used please list all in the
appropriate category)
Low
Yes, appropriate database and statistical software
has been identified, procedures for QC of data in
place.
High
Yes, outside the UK
Medium
Yes, within the UK
Low
No
High
Yes, not known to UCL
Medium
Yes, known to UCL
Low
No
High
31) Is there a requirement to audit the
IMP manufacturer or central service
providers (eg central laboratory)?
Medium
Low
Risk Management Plans
Manufacturer and/or central service provider require
auditing but insufficient trial funding available
Manufacturer and/or central service provider require
auditing but not completed before start of trial
Manufacturer and/or central service provider require
auditing and there is sufficient trial funding available
Manufacturer and/or central service provider have
been audited by appropriate Sponsor staff within the
last 2 years
Audit by questionnaire required only
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Section 6: IMP Information
Please tick all that apply and multiple score a category if it is applicable to more than one IMP
High
Not licensed in EU
Medium
IMP used outside EU MA.
Low
IMP used within their EU marketing authorisation(s)
IMPs used off-label if this off-label use is established
practice and supported by sufficient published
evidence and/or guidelines (such as in paediatrics
and/or oncology)
High
IMP without a marketing authorisation (MA) and no
human experimental data.
Medium
IMP without a marketing authorisation (MA) with
some human experimental data.
Low
IMP without a marketing authorisation (MA) in the
EU, but with MA outside EU.
32) Status of trial IMP(s)
33 If high risk in previous category,
please complete relevant category here
Advanced Therapy Medicinal Product
High
IMP classified as a Genetically Modified Organism
IMP consisting of manipulated tissues or cells
34) Type of IMP
35) Human Tissue Authority License(s)
(or equivalent outside UK) required for:
procurement, testing, processing,
storage, distribution, import, and/or export
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Medium
Biological or biotechnological product
Low
None of above
High
Yes, outside UK
Medium
Yes, within UK
Low
No
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High
IMP requires manufacture specifically for this trial
Medium
IMP requires further manipulation specifically for this
trial eg overencapsulation, radiolabelling
Low
None of above
High
IMP requires sourcing from outside UK
Medium
All IMPs provided for trial from UK source
Low
Hospital stock used for all IMPs
38) If previous question was answered as
high risk, please specify if IMP is sourced
from within or outside EEA.
High
Outside EEA
Low
Within EEA
39) IMP classified as needing advice from
the ‘Expert Advisory Group’ or
‘Commission on Human Medicines’ form
the MHRA
High
Yes
Low
No
High
Yes
Low
No
41) Will the IMP be provided free of
charge by a company specifically for use
in this trial
Medium
Yes
Low
No
42) Is the CI being paid by any
High
Yes
36) IMP manufacture
37) IMP sourcing
40) Is UCL responsible for producing IB
and IMPD?
Conflict of Interest
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commercial party for his/her involvement
in the trial?
43) Is the CI providing data to any of the
commercial parties involved in the trial for
the purpose of licensing the IMP or
varying the current marketing
authorisation?
44) Does the CI occupy a position of
Director, Partner, Consultant or Trustee in
any of the commercial parties involved in
the trial?
45) Is the CI a member of a committee
providing advice to any of the commercial
parties involved in the trial?
46) Does the CI have any Significant
Financial Interests in any of the
commercial parties involved in the trial?
47) Are there any potential intellectual
property issues?
48) Will the trial produce data that could
be used for commercialisation purposes ?
49) Does the CI or members of his/her
family have any significant financial
interests in the company/manufacturer
supplying the IMP or funding the trial?
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Low
No
High
Yes
Low
No
High
Yes
Low
No
High
Yes
Low
No
High
Yes
Low
No
High
Yes
Low
No
High
Yes
Low
No
High
Yes
Low
No
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Section 7: Other Issues - Sponsorship.
High
50) Is the CI currently under investigation
for misconduct, or for any other reason?
51) Are there any other issues that may
impede on the decision of UCL to take on
sponsorship/ EU representation for the
above trial?
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Yes
Low
No
High
Yes
Low
No
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Count risk factors (RF)
in each category1
Score for each
RF
High Risk
2
Medium Risk
1
Category
Score
Downgraded
RFs2
Adjusted
Score
ADJUSTED
TOTAL
TOTAL
Where more than one risk category has been checked in a question (e.g. one high and one medium) please count them both.
Downgrade RFs in to the category immediately below if a risk management plan is in place which eliminates or substantially ameliorates the risk. For each
RF you downgrade, subtract 1 from the Category Score column. For instance, if a High risk is downgraded to Medium, subtract 1; if two Mediums are
downgraded to Low risk, subtract 2.
2
YES/NO
Comment
Has the trial previously been reviewed by the sponsorship
oversight committee?
Does it now fall into one of the categories for automatic referral to
the SOC?*
*Please refer to SOC risk assessment template for list of automatic referral categories
Adjusted Total
Rating
Sponsorship Decision
26 to>36
High Risk
Refer to SOC
16 – 25
Moderate Risk
Consider referring to SOC, depending on proportion of high risks.
6 – 15
Moderate/Low Risk
Discuss with CTOM to give Sponsorship outside SOC
5 and under
Low Risk
Discuss with CTOM to give Sponsorship outside SOC
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Override
The SRA/ATMP
Regulatory Manager
performing the RA can
over-ride the calculated
rating and raise or lower it
if appropriate – this should
be discussed with a
manager and documented.
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Date risk assessment finalised with
CTOM/ Review in Clinical Trials Team:
‘Sponsorship in Principle’ decided outside SOC, and SOC to be informed at next sitting
Decision
(select one choice):

Trial to be presented and discussed at SOC
Name and signature of Sponsor
Regulatory Advisor/ATMP Regulatory
Manager
Date
Name and signature of Clinical Trial
Operations Manager/ JRO Director or
Deputy Director
Date
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