"Clinical Trial Indemnity Form" - Ireland

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Clinical Trial Indemnity Form
(“the Hospital”)
To:
(“the Authority
1
”)
(“the Investigator”)
Dr
(“the Sponsor”)
From:
(Enter Name of pharmaceutical company or other)
(“the Study”)
RE:
(Enter the full title of the protocol, including any protocol numbers and version dates)
1.
This agreement made on date signed by the parties is between
……………………………….. (Name of Pharmaceutical Company or other)
(“the Sponsor”) and …………………………………... (“the Hospital”) and
the ……………………….. (“the Authority”).
1.1 It is proposed that the Authority should agree to participate in the above
sponsored study (“the Study”) involving patients of the Authority (“the
Subjects”) to be conducted by Dr ……………………….. (“the Investigator”)
in accordance with the Protocol annexed, as amended from time to time with
the agreement of the Sponsor and the Investigator. The Sponsor confirms that
it is a term of its agreement with the Investigator that the Investigator shall
obtain all necessary approvals for the Study and shall resolve with the
Authority any issues of a revenue and resource nature.
2.
The Authority agrees to participate by allowing the Study to be undertaken on
its premises utilising such facilities, personnel and equipment, as the
Investigator may reasonably need for the purpose of the Study.
3.
In consideration of such participation by the Authority, and subject to
paragraph 4 below, the Sponsor indemnifies and holds harmless the Authority,
2
its employees and agents, including the Investigator and designate(s)
against
all claims and proceedings (to include any settlements or ex gratia payments
made with the consent of the parties hereto and reasonable legal and expert
costs and expenses) made or brought (whether successfully or otherwise)
3.1 by or on behalf of Subjects taking part in the Study (or their dependants)
against the Authority, its employees or agents including the Investigators and
designate(s) for personal injury (including death) to Subjects arising out of or
relating to the administration of the product(s) under investigation or any
clinical intervention or procedure provided for or required by the Protocol to
1
Note that in the case of HSE owned hospitals the term ‘Authority’ refers to the HSE.
2
An individual, a company, an institution or an organisation to which the Investigator has delegated
work relevant to the study.
SCA 25 10 13 (Version 3.0)
Page 1 of 3
Clinical Trial Indemnity Form
(“the Hospital”)
To:
(“the Authority
1
”)
(“the Investigator”)
Dr
(“the Sponsor”)
From:
(Enter Name of pharmaceutical company or other)
(“the Study”)
RE:
(Enter the full title of the protocol, including any protocol numbers and version dates)
1.
This agreement made on date signed by the parties is between
……………………………….. (Name of Pharmaceutical Company or other)
(“the Sponsor”) and …………………………………... (“the Hospital”) and
the ……………………….. (“the Authority”).
1.1 It is proposed that the Authority should agree to participate in the above
sponsored study (“the Study”) involving patients of the Authority (“the
Subjects”) to be conducted by Dr ……………………….. (“the Investigator”)
in accordance with the Protocol annexed, as amended from time to time with
the agreement of the Sponsor and the Investigator. The Sponsor confirms that
it is a term of its agreement with the Investigator that the Investigator shall
obtain all necessary approvals for the Study and shall resolve with the
Authority any issues of a revenue and resource nature.
2.
The Authority agrees to participate by allowing the Study to be undertaken on
its premises utilising such facilities, personnel and equipment, as the
Investigator may reasonably need for the purpose of the Study.
3.
In consideration of such participation by the Authority, and subject to
paragraph 4 below, the Sponsor indemnifies and holds harmless the Authority,
2
its employees and agents, including the Investigator and designate(s)
against
all claims and proceedings (to include any settlements or ex gratia payments
made with the consent of the parties hereto and reasonable legal and expert
costs and expenses) made or brought (whether successfully or otherwise)
3.1 by or on behalf of Subjects taking part in the Study (or their dependants)
against the Authority, its employees or agents including the Investigators and
designate(s) for personal injury (including death) to Subjects arising out of or
relating to the administration of the product(s) under investigation or any
clinical intervention or procedure provided for or required by the Protocol to
1
Note that in the case of HSE owned hospitals the term ‘Authority’ refers to the HSE.
2
An individual, a company, an institution or an organisation to which the Investigator has delegated
work relevant to the study.
SCA 25 10 13 (Version 3.0)
Page 1 of 3
which the Subjects would not have been exposed but for their participation in
the Study;
3.2 by the Authority, its employees or agents including the Investigator and
designate(s) by or on behalf of a Subject (or his dependants) for a declaration
concerning the treatment of a Subject who has suffered such personal injury.
4.
The above indemnity by the Sponsor shall not apply to any such claim or
proceeding:
4.1 to the extent that such personal injury (including death) is caused by the
negligent or wrongful acts or omissions or breach of statutory duty of the
Authority, its employees or agents including the Investigator and designate(s);
4.2 to the extent that such personal injury (including death) is caused by the
failure of the Authority, its employees or agents including the Investigator and
designate(s) to conduct the Study in accordance with the Protocol;
4.3 unless as soon as reasonably practicable following receipt of notice of such
claim or proceeding, the Authority shall have notified the Sponsor in writing
of it and shall, upon the Sponsor’s request, and at the Sponsor’s cost, have
permitted the Sponsor to have full care and control of the claim or proceeding
using legal representation of its own choosing;
4.4 if the Authority, its employees or agents including the Investigator and
designate(s) shall have made any admission in respect of such claim or
proceeding or taken any action relating to such claim or proceeding prejudicial
to the defence of it without the prior written consent of the Sponsor such
consent not to be unreasonably withheld, provided that this condition shall not
be treated as breached by a statement properly made by the Authority, its
employees or agents including the Investigator and designate(s) where (a) such
statement is required by law or (b) where the content and publication of such
statement has been agreed by the Authority and the Sponsor.
5.
The Sponsor shall keep the Authority and its legal advisers fully informed of
the progress of any such claim or proceeding, will notify the Authority of the
nature of any defence to be advanced and will not settle any such claim or
proceeding without notification to the Authority.
6.
Without prejudice to the provisions of paragraph 4.3 above, the Authority will
use its reasonable endeavours to inform the Sponsor promptly of any
circumstances reasonably thought likely to give rise to any such claim or
proceeding of which it is aware and shall keep the Sponsor reasonably
informed of developments in relation to any such claim or proceeding.
Likewise the Sponsor shall use its reasonable endeavours to inform the
Authority of any such circumstances and shall keep the Authority reasonably
informed of developments in relation to any such claim or proceeding made or
brought against the Sponsor in connection with the Study.
SCA 25 10 13 (Version 3.0)
Page 2 of 3
7.
The Authority and the Sponsor will each give to the other such help as may
reasonably be required for the efficient conduct and prompt handling of any
claim or proceeding by or on behalf of Subjects (or their dependants) or
concerning such a declaration as is referred to in paragraph 3.1 above.
8.
Without prejudice to the foregoing, if injury is suffered by a Subject while
participating in the Study, the Sponsor agrees to operate in good faith the
Guidelines published in 2013 by the Irish Pharmaceutical Healthcare
Association (IPHA) and entitled “Clinical Trial Compensation Guidelines”
and shall request the Investigator to make clear to the Subjects that the Study
is being conducted subject to those Association Guidelines.
For the purpose of this Indemnity, the expression “agents” shall be deemed to
9.
include any clinician or administrative official employed by the Authority
under a contract of service but to exclude independent contractors.
10.
This indemnity shall be governed by and construed in accordance with Irish
law.
11.
The Authority is entitled to rely fully upon the accuracy of all information
supplied to it by or on behalf of the Sponsor concerning the drugs under study
and is not required to obtain independent verification of any information
supplied.
SIGNED on behalf of the Authority
________________________________
Hospital Chief Executive
Date_____________________________
SIGNED on behalf of the Sponsor
_________________________________
Date_____________________________
SCA 25 10 13 (Version 3.0)
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