Clinical Trial Indemnity Form printable pdf download

Clinical Trial Indemnity Form

(“the Hospital”)

To:

(“the Authority

”)

(“the Investigator”)

(“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)

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.

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.

In consideration of such participation by the Authority, and subject to

paragraph 4 below, the Sponsor indemnifies and holds harmless the Authority,

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

Note that in the case of HSE owned hospitals the term ‘Authority’ refers to the HSE.

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)

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Clinical Trial Indemnity Form