Insurance Checklist for Studies involving Human Participants
Part 1
University Department :
Project Reference:
Chief Investigator for University:
Title of Trial:
Sponsor(s):
Please provide a brief description of the study:
For each question 1-8, please tick the appropriate box:
1a)
Is the proposed study a Non-hazardous Clinical Trial?*
Yes
No
* Please refer to attached guidance notes for definition of Nonhazardous Clinical Trial.
1b)
If the answer to question 1a) is “Yes”, will any part of the trial be
conducted outside of the European Union?
Yes
1c)
No
If the answer to question 1a) is “No”, will the trial involve the use of
research subjects outside Great Britain, Northern Ireland, the Channel
Islands or the Isle of Man?
Yes
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No
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2)
Will any post graduate students or undergraduate students be engaged
in the conduct or performance of the trial?
Yes
3)
Will the trial involve assisting with or altering in any way the process of
conception or investigating or participating in methods of
contraception?
Yes
4)
No
Is the trial being sponsored by a pharmaceutical manufacturer or
similar commercial organisation?
Yes
8b)
No
Will written informed consent be obtained either from the research
subject or their legal guardian?
Yes
8a)
No
Will (or could) the total number of research subjects exceed 5,000?
Yes
7)
No
Will the trial involve research subjects known to be pregnant at the time
of the trial?
Yes
6)
No
Will the trial involve the use of a drug or medical device designed or
manufactured by the University?
Yes
5)
No
No
If the answer to question 8a) is “Yes”, is the pharmaceutical
manufacturer or similar commercial organisation providing insurance
cover?
Yes
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No
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If any of the answers to Q1b), 1c), or Q2–6 is “Yes”, or any answer to Q7 or
Q8a or 8b is “No”, the trial may need to be submitted to the University’s
insurers for further consideration. Please contact Dr Debra Stuart in the
University’s Research Governance Office: debra.stuart@glasgow.ac.uk
for advice if your study falls into either category.
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Insurance Commencement Form for Studies Involving Human
Participants
Part 2
Please refer to the definitions set out in the attached Guidance Notes and
then tick ONE of the following which best describes this trial:
Clinical Trial of an Investigational Medicinal Product (CTIMP)
Non CTIMP Drug Trial
Excluded Trial
Non Hazardous Clinical Trial
All other Trials
In what capacity is the University acting in respect of the trial? Please
read all of the 4 options below (Sections A – D) and then select ONE by
ticking the most appropriate box and completing the requested
information.
Section A.
Sponsor (or Co-Sponsor with NHS GG&C in the case of a CTIMP) of the trial
where the University is the only participating centre and all Research Subjects
will be recruited by the University to the trial.
Please advise the total number of Research Subjects to be recruited to the
trial:
…………………………….….
Section B.
Sponsor (or Co-Sponsor with NHS GG&C in the case of a CTIMP) of a multicentre trial involving both the University as a trial centre and other trial sites.
Please supply details requested below:
1) Total number of Research Subjects to be recruited by the University to the
trial.
…………………………….….
2) Total number of Research Subjects to be recruited to the trial by other
participating sites.
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…………………………….….
3) Are all other participating sites contractually required to provide insurance
cover for injury to their own Research Subjects?
Yes
No
If “Yes”, please provide a brief description of the participating site insurance
cover:
Section C.
As a participating centre in a multi-centre trial where others are acting as
Sponsor of the trial:
Please supply details as requested below.
1) Total number of Research Subjects to be recruited by the University to the
trial.
…………………………….….
2) Is insurance being provided by the trial Sponsor?
Yes
No
If “Yes”, please provide a brief description of the Sponsor insurance cover:
Section D.
As a participating centre in a single site trial where others are acting as
Sponsor of the trial.
Please supply details as requested below:
1) Total number of Research Subjects to be recruited by the University to the
trial.
…………………………….….
2) Is insurance being provided by the trial Sponsor
Yes
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No
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If “Yes”, please provide a brief description of Sponsor insurance cover:
In each case, please advise any other information regarding the
University’s role in the trial that you consider may be of importance or
would assist the Insurers’ understanding of the trial.
THE FORM MUST BE SIGNED AND DATED (BELOW) BEFORE IT IS
RETURNED
Signed
Role in Trial
Date
For Clinical Trials of Investigational Medicinal Products and of Non CTIMP
Drug Trial please return the completed form to Dr Debra Stuart, Research
Governance Manager, Tennent Institute, Church Street, Western infirmary.
For all other types of trials please return the completed form to Mr Paul Ellis,
Senior Contracts Manager, Research Support Office, No 10 the Square.
GUIDANCE NOTES
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How is a Clinical Trial defined by the University Insurers?
The University’s insurer considers a Clinical Trial to mean an investigation or
series of investigations conducted on persons for a Medicinal Purpose and
authorised by the relevant ethics committee.
Medicinal Purpose means;
a) treating or preventing disease;
b) diagnosing disease or ascertaining the existence degree of or extent
of a physiological or psychological condition;
c)
assisting with or altering in any way the process of conception or
investigating or participating in methods of contraception;
d) inducing anaesthesia; or
e) otherwise preventing or interfering with the normal operation of a
physiological or psychological function in order to improve health or
well-being.
Clinical Trial of an Investigational Medicinal Product (CTIMP)
A CTIMP is any investigation in human subjects intended to:



discover or verify the clinical, pharmacological and/or pharmacodynamic
effects of one or more investigational medicinal product(s) (IMP);
identify any adverse reactions to one or more IMPs;
study absorption, distribution, metabolism and excretion of one or more
IMPs with the object of ascertaining the safety or efficacy of those
products.
If you think your trial falls into this category, please contact the Research
Governance Manager (debra.stuart@glasgow.a.c.uk) to discuss the project in
more detail.
Non CTIMP Drug Trial
Drug trials of Non-Investigational Medicinal Products (Non-CTIMPs) are
studies which do not use Investigational Medicinal Products (IMPs) as defined
by the Medicines and Healthcare products Regulatory Agency (MHRA). In
studies of this nature standard drug treatment is given (i.e. using the drug for
the purpose for which it is marketed and sold by the manufacturer), not an
experimental treatment.
Excluded Trials
Certain Clinical Trials are excluded, by our insurers, from automatic cover.
Your answers to Part 1 of this form should elicit the required information to
determine whether a trial is excluded from automatic cover. In summary,
excluded trials are:

large scale trials involving more than 5000 Research Subjects;
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



trials involving conception or contraception;
trials involving pregnant women;
trials involving Research Subjects who are resident outside Great Britain,
Northern Ireland, the Channel Islands or the Isle of Man;
trials where the substance under investigation has been designed and/or
manufactured by the University.
Sometimes cover can be provided for such trials at additional cost, but the
University’s insurers will require individual notification in advance with full
details (e.g. trial protocol / ethics application and patient information sheet)
and cover is not provided unless we specifically agree in writing.
Non-hazardous Clinical Trial
Non-hazardous Clinical Trials are those trials which involve one or more of the
following only:






the insertion of needles into patients' veins for the purpose of withdrawing
blood samples;
the measurement of physiological processes using non-invasive methods;
the measurement of psychological processes using non-invasive methods
of data gathering from surveys, questionnaires or interview of Research
Subjects;
the administration by mouth of foods or variation of diet other than the
administration of drugs or food supplements;
the collection of body secretions and excretions by non-invasive methods
for analysis;
the use of tissue samples which would otherwise be disposed of subject to
i) written informed consent in accordance with the Applicable Legislation
being obtained in all cases;
ii) the storage and disposal of such tissue material in accordance with the
Applicable Legislation once the research has been undertaken;
iii) such tissue material not having been obtained in connection with any
other Clinical Trial.
All other Trials
These are all other Clinical Trials which do not fall into any of the above
categories.
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